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

Model Number M00201503066B0

Device Problem Delamination (2904)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2014

Event Type  malfunction  

Event Description

The hospital reported that during a below knee left fem pop bypass with fusion bioline 6mm-60cm supp peripheral, the surgeon used a gore tunneler, placed 6x60 ringed fusion bioline graft, removed some of the rings, cut the end of the graft to angle into patient's vein and the pet layer became detached from the ptfe layer completely.This also occurred on the other end of the graft as well and was difficult to suture both layers together due to the angle of placement (deep behind patient's knee - not easy visual for surgery) case was delayed because patient received platelets prior.

Manufacturer Narrative

The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.There was no nonconformance recorded in the lot history which would be considered related tot he reported event.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 ; 9737097690
• MDR Report Key: 4105464
• MDR Text Key: 4718462
• Report Number: 2242352-2014-00982
• 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: 08/13/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: M00201503066B0
• Device Lot Number: 25091275
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/19/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/13/2014
• Initial Date FDA Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: No
• 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