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

Model Number FUSION 6MM-40CM SUPP PERIPHERAL GRAFT

Device Problem Use of Device Problem (1670)

Patient Problems No Patient Involvement (2645); Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Trackwise id # (b)(4).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.

Event Description

This is notice of a potential product quality complaint received during market research study 16755 conducted by incrowd.Reporter id: 16755 - 2045178 q4: (when performing anastomosis, does the thread glide through the graft with ease?)a: acceptable comment: sometimes the prosthesis is difficult to pierce no patient involvement.

Event Description

N/a.

Manufacturer Narrative

Trackwise # (b)(4).Analysis of production for ship history conducted: (3331/213/67) a lot history record review was completed for lots 25150268 and 25151894 the last 2 lots shipped prior to the event/aware date.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.

• Brand Name: FUSION 6MM-40CM SUPP PERIPHERAL GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10406991
• MDR Text Key: 202913668
• Report Number: 2242352-2020-00714
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384409005690
• UDI-Public: 00384409005690
• Combination Product (y/n): N
• PMA/PMN Number: K131778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

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 Model Number: FUSION 6MM-40CM SUPP PERIPHERAL GRAFT
• Device Catalogue Number: FUSION VASCULAR GRAFT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 10/29/2021
• Supplement Dates FDA Received: 11/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1