MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 8"(20CM) 2-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8533H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional evaluation summary: representative samples were received for product code 8533, lot kdh036.During the visual inspection of the samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were observed.A functional test was performed and the tensile strength force was above the minimum requirement.Per the condition of the representative samples, no suture breakage was found and the tested samples met the finished goods requirements.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What suture was used to complete the anastomosis? product code and lot number? what is the physician¿s opinion as to the etiology of or contributing factors to the patient¿s death? the patient demographic info: age, gender, weight, bmi at the time of index procedure date of the index surgical procedure the diagnosis and indication for the index surgical procedure in what tissue was the suture placed? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? what suture was used to complete the anastomosis? product code and lot number? date of patient death? was an autopsy performed? if yes, can you provide report of findings? other relevant patient history/concomitant medications, lot number.Device return status?.
Event or Problem Description
It was reported that a patient underwent an aortic aneurysm procedure on an unknown date and suture was used.The suture was used to complete the aortic aneurysm anastomosis.Four different sutures were used and each one snapped whilst doing intricate work of the aortic aneurysm anastomosis.The case was completed using a different product.The patient was okay after the procedure however passed during the night.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to fda: 11/1/2019.

• Brand Name: PROLENE SUTURE 8"(20CM) 2-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9267906
• Report Number: 2210968-2019-89399
• Device Sequence Number: 16677298
• Product Code: GAW
• UDI-Device Identifier: 10705031016743
• UDI-Public: 10705031016743
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 8533H
• Device Lot Number: KDH036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 11/01/2019
• Patient Sequence Number: 1