MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC FUSION BIOLINE 6MM-80CM SUPP PERIPHERAL; VASCULAR GRAFT

Model Number M00201503086B0

Device Problems Split (2537); Delamination (2904)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/27/2014

Event Type  malfunction  

Event Description

The hospital reported that during femoropopliteal bypass surgery, an extra piece of graft was trimmed off the fusion bioline 6mm-80cm supp peripheral main graft.Later it delaminated on the back table.The piece was cut off with scissors and was not used on the patient.The piece split in two pieces, ptfe and other dacron.The hospital did not report any patent effects.

Manufacturer Narrative

Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.A lot history record review was completed for the reported product lot number.There was no non-conformance recorded in the lot history.(b)(4).

• Brand Name: FUSION BIOLINE 6MM-80CM 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: 3818604
• MDR Text Key: 4450576
• Report Number: 2242352-2014-00365
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2014

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: 07/31/2016
• Device Model Number: M00201503086B0
• Device Lot Number: 25081231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2014
• Initial Date FDA Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 58 YR