MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN VASCUFIL; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	88864704-11V
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the open congenital heart procedure, after 3 hours during the anastomoses, the thread broke.The incision was extended due to the product issue.An alternative product was used to complete the case.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during open congenital heart procedure, after 3 hours during the anastomoses, the thread broke.The incision was extended due to the product issue.An alternative product was used to complete the case.No patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during open congenital heart procedure, after 3 hours during the anastomoses, the thread broke.The incision was extended due to the product issue.An alternative product was used to complete the case.No patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.A visual inspection of the returned product noted two needles and one suture.The needles were parked in the foam, and the sutures were coiled within the retainer.When pmv tried to remove the suture, it was found that the suture was in four pieces.A large cut was made in the foil which extended to the retainer.From the way the suture was cut, it appears that the cut into the retainer was the cause of the broken suture.Functional testing could not be performed.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VASCUFIL
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7731960
• Report Number: 1219930-2018-04160
• Device Sequence Number: 2770684
• Product Code: GAT
• UDI-Device Identifier: 20884521101842
• UDI-Public: 20884521101842
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K990952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/16/2019

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 Expiration Date: 04/30/2021
• Device Model Number: 88864704-11V
• Device Catalogue Number: 88864704-11V
• Device Lot Number: A6D0142X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 07/13/2018; 08/08/2018; 01/24/2019; 03/28/2019
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 08/02/2018; 10/03/2018; 02/19/2019; 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1