MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 36"(90CM) 4-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	8581H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.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.
Event or Problem Description
It was reported that a patient underwent an aortic valve replacement on (b)(6 )2019 and suture was used.During the procedure, the suture broke while tying the knot.The procedure was completed with an alternate like device with no adverse patient consequences reported.No additional information was provided.

• Brand Name: PROLENE SUTURE 36"(90CM) 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: 8479719
• Report Number: 2210968-2019-79990
• Device Sequence Number: 1018949
• Product Code: GAW
• UDI-Device Identifier: 10705031017368
• UDI-Public: 10705031017368
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/12/2019

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: 8581H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 04/03/2019
• Patient Sequence Number: 1