Alerta De Seguridad para NC Trek RX Coronary Dilatation Catheter

Safety alert

2017-184

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/440889-fda-advisory-no-2017-184

Fda advisory no. 2017-184 voluntary recall nc trex rx coronary dilatation catheter, with mdr-00260 all are hereby advised by the food and drug administration (fda) about the voluntary recall of the following nc trex rx coronary dilatation catheter with mdr-00260 product code 1012448-06,1012448-08,1012448-12,1012448-20, 1012449-08, 1012449-12, 1012449-20, 1012449-25, 1012450-06, 1012450-08, 101250-15, 101251-12, 101251-15, 1012452-08, 1012452-12, 1012453-12, 1012453-15, 1012453-20 distributed by getz bros. philippines, inc. 5th floor ortigas bldg., ortigas avenue, pasig city: product code: mdr-00260 description: nc trex rx coronary dilatation catheter (2. 75 mm, 3.00 mm, 3.25 mm, 3.50 mm, 3.75 mm & 4.00 mm) product code lot numbers product code         lot numbers                 1012448-06       60414g1 60721g1         1012448-20 60310g1 60421g1 60421g2 60527g1 60716g1 60819g1 60024g2         1012448-08             1012551-25     60208g1 60419g1 60420g1 60603g1 60906g1 61121g1 61121g2     60809g1               1012449-08 60317g1 60318g1 60412g1 60419g1 60502g1 60502g2 60525g1 60705g1 60801g1 60809g1 60826g1 60916g1 61121g1 61121g2         1012448-12                         1012448-12                                  1012449-20                     1012453-20 60225g1 60229g1 60318g1 60318g2 60429g1 60429g2 60607g1   60705g1 60804g1 60818g1 60921g1 60921g2 61108g1 61111g1 61128g1 61128g2 61218g1   60126g1 60223g1 60225g1 60226g1 60323g1 60331g2 60516g1 60519g1 60721g1 60805g1 60824g1 60907g1 61004g1 61116g1 61130g1   60209g1 60226g1 60505g1 60623g1 61122g1       1012449-12                                         1012449-12 60218g1 60303g1 60330g1 60330g2 60406g1 60406g2 60406g3 60406g4 60408g1 60413g1 60413g2 60425g1 60429g1 60511g1 60512g1 60531g1 60607g1 60623g1 60713g1 60721g1 60804g1 60805g1 60809g1 60816g1 60824g1 60926g1 60929g1 61012g1 61019g1 61019g2 61020g1 61115g1 61121g1 61122g1 61123g1 61123g2 61201g1 61208g1 61214g1 61214g2 61216g1 61216g2      1012451-12           1012452-08             1012450-15                             1012451-15   60205g1 60214g1 60502g1 61108g1 61213g1   60810g1 60921g1 61007g1 61216g1   60315g1 61130g1 60718g1 60901g1 60922g1 61128g1 60414g2 60505g1 60331g1 60224g1     60210g1 60224g1 60331g1 60505g1 60408g2 60913g1 60909g2 60828g2 60826g1 60727g1 60701g1 60607g1 60603g1     1012449-25       1012450-06         1012450-08         1012452-12       1012453-12                   1012453-15   60405g1 60412g1 60805g1     60610g1 61101g1   60530g1 60803g1 61014g1 61206g1   50109g1 50316g1 50210g1   60705g1 60810g1 60502g1 60621g1     60301g1 61111g1 61026g1 61121g1 60822g1 60428g1 60819g1 60331g1 60721g1 60909g1 60613g1 60303g1 60617g1 the cited product are being voluntarily recalled by getz bros. philippines, inc. because abbot vascular has initiated a voluntary field action regarding specific lots of the nc trex rx coronary dilatation catheter, nc traveller rx coronary dilatation catheter, and nc tenku rx ptca ballon catheter. production from the identified lots may exhibit difficult in removing the protective ballon sheath which can result in issues with inflating or deflating the ballon. the worldwide frequency of tight sheath removal, inflation and deflation and reported event is 0.12%. potential risks associated with ballon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardiac infarction. in one reported case, failure to deflate the ballon necessitated surgery, leading to multiple post-operative complication and death. distributors, retailers, hospitals that have any of the stated medical device product are instructed to discontinue further distribution, sale and use. all consumers are likewise advised not to purchase or use the affected product lots. any suspected adverse reaction experienced or any incident of the same cases from the use of the device but not limited to the lots stated above, should be reported immediately to fda at telephone no. (02) 857-1900 loc. 8301 or email us at this email address is being protected from spambots. you need javascript enabled to view it. . dissemination of the information to all concerned is requested. attachments: fda advisory no. 2017-184.Pdf.