MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SURGIPRO II; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	VP-735-X
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2018
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 a coronary artery bypass graft on the saphenous vein, the suture detached from the needle and strand on vessel anastomosis.A new device with the same lot number was used to complete the case.There was no patient injury reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGIPRO II
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7682793
• Report Number: 1219930-2018-03776
• Device Sequence Number: 906607
• Product Code: GAW
• UDI-Device Identifier: 20884521038810
• UDI-Public: 20884521038810
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K050947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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: 10/31/2022
• Device Model Number: VP-735-X
• Device Catalogue Number: VP-735-X
• Device Lot Number: A7K0264SX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1