ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Sep 17, 2009 · Event occurred Aug 18, 2009
Report 2210968-2009-01050 · MDR key 1502940
Device
Generic name
Suture, Non-absorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
XZW10B55
Lot number
ADE386
Product problems
- Detachment Of Device Component
Patient
UNK
- No Consequences Or Impact To Patient
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
INTERNATIONAL CUSTOMER REPORTED THAT A PT UNDERWENT A MITRAL VALVE REPAIR. THE SURGEON REQUESTED ECG AND NOTICED BLEEDING ALONG THE SUTURES SECURING THE VALVE. THE SURGEON RECANNULATED THE PT AND REOPENED THE HEART TO ACCESS THE MITRAL VALVE. THE SURGEON NOTICED THAT 2 OF THE 11 SUTURES SECURING THE VALVE HAD LOOSENED. A PLEDGET FROM ONE OF THE LOOSENED SUTURES CAME OFF AND FELL IN THE PT'S BODY. THE PLEDGET WAS NOT RETRIEVED THE SUTURES WERE REMOVED AND DISCARDED AND REPLACED WITH COMPETITOR PRODUCT.
Additional Manufacturer Narrative
(B)(4). (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.