MAUDE Adverse Event Report: ETHICON INC. PRONOVA SUTURE 24IN (60CM) 8-0 BLU; SUTURE, NON ABSORBABLE, SYNTHETIC

Catalog Number	PN3741LG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cabg procedure on (b)(6) 2023 and suture was used.During the procedure, the suture was broken during lita-lad anastomosis.The broken suture was tied off and a new suture was used to continue, but suture breakage occurred again.Sutures broke 3 times in total, but the anastomosis was somehow completed.No problem with the patient¿s condition now.The operation time was extended within 30 minutes.The products were used on blood vessel.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # = > pc-(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 via: "1.Please provide lot number=> unk 2.Was there any change in the patient¿s post-operative care due to the prolonged procedure?=> no events reported via: 2210968-2023-06023, 2210968-2023-06024, 2210968-2023-06025.

• Brand Name: PRONOVA SUTURE 24IN (60CM) 8-0 BLU
• Common Device Name: SUTURE, NON ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17584796
• Report Number: 2210968-2023-06024
• Device Sequence Number: 4880489
• Product Code: GAW
• UDI-Device Identifier: 10705031238374
• UDI-Public: 10705031238374
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K001625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2023

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: PN3741LG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown