ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received May 25, 2011
Report 2210968-2011-00669 · MDR key 2103074
Device
Generic name
Suture, Non-absorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
SXP82
Lot number
ALB999
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4)- PLEDGET FRAYING. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.
Additional Manufacturer Narrative
(B)(4). CONCLUSION: ONE RETURNED OPENED PACKAGE WAS EXAMINED UNDER A STEREOMICROSCOPE AT 10-50X. FIVE GREEN AND FIVE WHITE DOUBLE-ARMED PLEDGETED SUTURES WERE PRESENT. EACH OF THE PLEDGETS WERE EXAMINED AND IMAGED AND ALL WERE CONSISTENT WITH THE SOFT CUT PLEDGETS. THE IMAGED PLEDGETS ON THE SUTURE COULD BE INTERPRETED AS FLUFFY. THE PRODUCT PACKAGING ALSO INDICATED THE PLEDGETS AS SOFT TFE POLYMER PLEDGETS. THE END-USER'S CONCERNS MIGHT BE BETTER ADDRESSED BY USING A SUTURE PRODUCT WITH A HARD PLEDGET. 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 PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT PROCEDURE ON AN UNKNOWN DATE. THE SURGEON STATED THAT THE PLEDGETS ARE NOT ALL COMPRESSED LIKE THEY SHOULD BE AND SOME WERE FLUFFY AND FRAYING. THE SURGEON WAS WORRIED THAT IT WILL COME APART INSIDE THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.
Remedial action
- Other