MalfunctionGAS
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Jan 28, 2011
Report 2210968-2011-00082 · MDR key 1990515
Device
Generic name
Suture, Non-absorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
X523H
Lot number
BLK264
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNK
- Nonresorbable materials, unretrieved in body
Narrative
Additional Manufacturer Narrative
(B)(4): CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
Description of Event or Problem
IT WAS REPORTED THAT A PT UNDERWENT A MITRAL VALVE REPLACEMENT SURGERY IN (B)(6) 2009 AND SUTURE WAS USED. THE PT WAS TOLD THAT A NEEDLE IS STUCK IN OR NEAR A PULMONARY VEIN AND SITUATED AGAINST THE LUNG. NO ADDITIONAL INFO WAS PROVIDED.