MAUDE Adverse Event Report: MAQUET CV FUSION 8MM-40CM SUPP PERIPHERAL GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Catalog Number VS015030480

Device Problem Break (1069)

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

Event Date 05/12/2016

Event Type  malfunction  

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.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 the procedure, fusion 8mm-40cm supp peripheral graft was broken longitudinally.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).The device was returned to factory for evaluation.Signs of clinical use and evidence of blood were observed.There was no blood found in the eptfe layer of the graft.The knit polyester textile outer layer was covered with blood.A clean longitudinal cut with a frayed segment was observed on the eptfe inner layer.The smoothness of the cut indicates that the cut was made with a sharp scalpel.There was no cut observed on the outer textile layer.Based on the return condition of the device and the evaluation results, the reported complaint for the failure mode "cut in material" is confirmed.The dhr for the lot was reviewed.There were no nonconformance's found in the lot.The lot meet all the specifications criteria.

Event Description

The hospital reported that during the procedure, fusion 8mm-40cm supp peripheral graft was broken longitudinally.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).

Event Description

The hospital reported that during the procedure, fusion 8mm-40cm supp peripheral graft was broken longitudinally.The hospital did not report any patient effects.

• Brand Name: FUSION 8MM-40CM SUPP PERIPHERAL GRAFT
• 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: 5748237
• MDR Text Key: 48858477
• Report Number: 2242352-2016-00587
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/30/2016

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: 11/30/2018
• Device Catalogue Number: VS015030480
• Device Lot Number: 25120391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2016
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Initial Date Manufacturer Received: 05/30/2016
• Initial Date FDA Received: 06/24/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/15/2016; 11/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2015
• 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