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

Model Number M00201503086B0

Device Problem Material Frayed (1262)

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

Event Date 01/09/2015

Event Type  malfunction  

Event Description

The hospital reported that the external rings were difficult to remove and the fusion bioline 6mm-80cm supp peripheral "frayed" some when the rings were removed.The graft was implanted.The hospital did not report any patient 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.There was no nonconformances recorded in the lot history which would be considered related to the reported event.There are no other similar complaints reported against this batch.Internal complaint number - (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 ; 9737097265
• MDR Report Key: 4511512
• MDR Text Key: 21770422
• Report Number: 2242352-2015-00037
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/14/2015

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: 10/31/2016
• Device Model Number: M00201503086B0
• Device Lot Number: 25086509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2015
• Initial Date FDA Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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