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
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Patient Involvement (2645); Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem Description
N/a.
Additional 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
• Common Device Name: 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
• Report Number: 2242352-2020-00714
• Device Sequence Number: 2403785
• Product Code: DSY
• UDI-Device Identifier: 00384409005690
• UDI-Public: 00384409005690
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: GM
• PMA/510(K) Number: K131778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1