MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC. FUSION BIOLINE 6MM-60CM SUPP PERIPHERAL; VASCULAR GRAFT

Model Number M00

Device Problem Delamination (2904)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2014

Event Type  malfunction  

Event Description

The hospital reported that during femoral-popliteal bypass procedure, the surgeon tunnelled the graft as usual.After making a cut in the graft to match it with the vessel, he began to suture the graft into place.While suturing, he commented that the dacron outer layer was peeling away from the ptfe.The surgeon continued to suture, then stated that the ptfe was shredding at the end and pulling part.The end of the graft was cut and the remainder of the graft was used without any issues.It was reported that no cutting needle was used.

Manufacturer Narrative

The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.There are no other similar complaints reported against this batch.(b)(4).

• Brand Name: FUSION BIOLINE 6MM-60CM SUPP PERIPHERAL
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): MAQUET CARDIOVASCULAR, LLC.; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR, LLC.; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4207062
• MDR Text Key: 21240496
• Report Number: 2242352-2014-01153
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: M00
• Device Catalogue Number: VS01503066B0
• Device Lot Number: 25091278
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1