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

Model Number	88864710-11V
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This event was originally reported on a quarterly summary report and is being resubmitted per fda request.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: during an open cabg procedure at the proximal anastomosis, the needle popped off of the thread.To complete the case another suture was used.No medical or surgical intervention was required.There was no injury to the patient.

• Brand Name: VASCUFIL
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• MDR Report Key: 6814151
• Report Number: 1219930-2017-06611
• Device Sequence Number: 19074943
• Product Code: GAT
• UDI-Device Identifier: 20884521101903
• UDI-Public: 20884521101903
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K990952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2017

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: 08/31/2019
• Device Model Number: 88864710-11V
• Device Catalogue Number: 88864710-11V
• Device Lot Number: A4H0570X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2017
• Initial Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1