MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 54"(135CM) 4-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	D7870
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).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: how long was the wait time in the procedure due to this issue? 5 minutes.Was any intervention provided due to lack of blood flow during the wait time? no.Did only 1 suture break during this procedure? more than one.Was patient's post-operative care changed? no.Lot number, not none.The single complaint was reported with multiple events.There are no additional details regarding the additional patient events.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.Can you clarify the number of patient events the suture broke? were the other events reported? what are the complaint numbers? please provide the following for each event: date of the procedure? what is the specific number of devices that failed in each procedure? was there any patient consequence during the procedure? how long was the wait time in the procedure due to this issue? additional device reported in mw 2210968-2019-81532.
Event or Problem Description
It was reported that the patient underwent a cardiovascular procedure on an unknown date and suture was used.The suture broke when creating the anastomosis.The patient had no inbound blood supply at the moment.The procedure was delayed around 5 minutes.Another device was used to complete the procedure.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: can you clarify the number of patient events the suture broke?: 2.Were the other events reported?: no.Please provide the following for each event: date of the procedure?: not known.What is the specific number of devices that failed in each procedure?: 2.Was there any patient consequence during the procedure?: no.How long was the wait time in the procedure due to this issue?: 7min.Note: events reported via 2210968-2019-81531, 2210968-2019-81532, 2210968-2019-83334, 2210968-2019-83335.

• Brand Name: PROLENE SUTURE 54"(135CM) 4-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8625039
• Report Number: 2210968-2019-81531
• Device Sequence Number: 1654741
• Product Code: GAW
• UDI-Device Identifier: 10705031028708
• UDI-Public: 10705031028708
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

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: Health Professional
• Device Catalogue Number: D7870
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 06/26/2019
• Patient Sequence Number: 1