MAUDE Adverse Event Report: MAQUET CV FUSION BIOLINE 7MM-80CM SUPP PERIPHERAL; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Catalog Number M00201503087B0

Device Problem Device Slipped (1584)

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

Event Date 05/12/2016

Event Type  malfunction  

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 nonconformance recorded in the lot history.(b)(4).

Event Description

The hospital reported that during a fem pop bypass, the rings on a fusion bioline graft became loose with only a small bit of manipulation of the graft.This began at the factory edge of the product without any prior removal of the ringed segment.This was at the proximal arterial anastamosis at the common femoral artery.At the distal anastamosis to the popleteial artery, the graft was cut to length.The ringed portion unraveled 5 to 6 spirals above where it was cut and did not provide the doctor the support that they were looking for.The graft was previously soaked in 50k units of bacitracian for 15 minutes before implant.Product was implanted and the patient is doing very well.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).The release testing records were reviewed for the bead peal strength.The graft profile results were also reviewed.There were no non-conformances observed in the bead peel or the graft profile values recorded during release testing.

Event Description

The hospital reported that during a fem pop bypass, the rings on a fusion bioline graft became loose with only a small bit of manipulation of the graft.This began at the factory edge of the product without any prior removal of the ringed segment.This was at the proximal arterial anastamosis at the common femoral artery.At the distal anastamosis to the popliteal artery, the graft was cut to length.The ringed portion unraveled 5 to 6 spirals above where it was cut and did not provide the doctor the support that they were looking for.The graft was previously soaked in 50k units of bacitracin for 15 minutes before implant.Product was implanted and the patient is doing very well.The hospital did not report any patient effects.

• Brand Name: FUSION BIOLINE 7MM-80CM SUPP PERIPHERAL
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 5718517
• MDR Text Key: 48146078
• Report Number: 2242352-2016-00548
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: M00201503087B0
• Device Lot Number: 25121938
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 08/31/2016
• Date Device Manufactured: 01/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1