MAUDE Adverse Event Report: MAQUET CV FUSION 7MM-40CM SUPP PERIPHERAL GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Catalog Number VS015030470

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.

Event Description

The hospital reported during surgery for occlusive arterial disease, fusion 7 mm-40 cm supp peripheral graft leaked (yellowish fluid ¿ seemed to be plasma) from the graft surface, while it was being used as a perfusion line.The amount of leakage was about 2l.It occurred during the pcps and the internal pressure of the graft seemed to be approx.300 mmhg.The customer assumed that the leak was from the ptfe pores.The surgery was finished with no adverse event.

Manufacturer Narrative

Internal complaint number trackwise #(b)(4).Autonumber # (b)(4).The device was returned to factory for evaluations.Signs of blood and clinical usage were observed.The graft was covered in blood with one end connected to a connector.The other end of the graft had a litter impression of blood indicating that the end was probably connected to another connector.There were no signs of the graft being torn.A flow and leak test were performed.Water was run through the graft.There was no leak observed.To check the leakage through the pores, the graft was soaked in a water bath.There were no bubbles observed.Based on the return condition of the product and the investigation results, the reported failure was not confirmed.The device was used as a perfusion line for pcps.As per the ifu, the intended use of fusion grafts are designed to repair or replace peripheral arteries, indicating that the device was used off label.

Event Description

The hospital reported during surgery for occlusive arterial disease, fusion 7mm-40cm supp peripheral graft leaked (yellowish fluid ¿ seemed to be plasma) from the graft surface, while it was being used as a perfusion line.The amount of leakage was about 2l.It occurred during the pcps and the internal pressure of the graft seemed to be approx.300mmhg.The customer assumed that the leak was from the ptfe pores.The surgery was finished with no adverse event.

• Brand Name: FUSION 7MM-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
• MDR Report Key: 7165823
• MDR Text Key: 96592373
• Report Number: 2242352-2018-00017
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K153523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: VS015030470
• Device Lot Number: 25131731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Device Age: YR
• Date Manufacturer Received: 03/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1