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

Model Number	VP-735-X
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	03/29/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter: during cabg triple graft with lad lima connection (open procedure), sutures threads broke when the surgeon threw an knot while performing distal anastomosis.Suture was hydrated to make passage smooth.The surgeon employed continuous suturing technique.The patient has to be shifted from beating heart to on pump surgery because of continuous breaking of distal anastomosis suture which triggered the blood pressure of the patient to prevent permanent impairment of a function so it led to extension in surgical time up to 2 hours.The device was being applied to saphenous vein.There was unanticipated tissue loss as a result of this problem.There was tissue damage due to continuous needle prick as the thread was breaking continuously so surgeon had to harvest another vein for the additional graft as a result of this problem.Used another suture to resolve the issue in order to complete the case.Patient was temporarily injured.
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 NORTH HAVEN - MFG; 195 mcdermott road; north haven CT 06473
• MDR Report Key: 6525343
• Report Number: 1219930-2017-05373
• Device Sequence Number: 13859787
• Product Code: GAW
• UDI-Device Identifier: 10884521038813
• UDI-Public: 10884521038813
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K010909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: VP-735-X
• Device Catalogue Number: VP-735-X
• Device Lot Number: A6C0779X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2017
• Supplement Date Received by Manufacturer: 03/30/2017
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Other; Required Intervention
• Patient Age: 58 YR