MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC FUSION BIOLINE 8MM-40CM SUPP PERIPHERAL GRAFT; VASXCULAR GRAFT

Model Number M002015030480

Device Problem Delamination (2904)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/07/2015

Event Type  malfunction  

Event Description

The hospital reported that fusion bioline 8mm-40cm unsupp peripheral graft, was used for femoral bypass procedure.When the surgeon cut the anastomotic part at a diagonal line and removed a ring, the eptfe and knitted fabric was found peeled off.The customer managed to use the product for the patient.The other side was cut after a ring was removed and no peel-off occurred.Hospital reported no patient injury effects.

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.(b)(4).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).

Manufacturer Narrative

The reported graft segment was not returned to the factory for evaluation because the hospital was able to use that segment for the patient.The graft segment that was returned showed evidence of clinical use and evidence of blood.No evidence of long term implantation was observed.Based on the received condition of the device, we were unable to confirm the reported complaint for "delamination".The device history record (dhr) for this product lot was reviewed.The lot conformed to all applicable specifications and passed shear bond strength testing.The root cause is undetermined at this time because the event occurred during the use of the device and the procedural operation is unavailable for review.

• Brand Name: FUSION BIOLINE 8MM-40CM SUPP PERIPHERAL GRAFT
• Type of Device: VASXCULAR 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: 4759519
• MDR Text Key: 19722493
• Report Number: 2242352-2015-00378
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: M002015030480
• Device Lot Number: 25095076
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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