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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC FUSION 8MM-60CM SUPP PERIPHERAL GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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MAQUET CARDIOVASCULAR LLC FUSION 8MM-60CM SUPP PERIPHERAL GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER Back to Search Results
Model Number FUSION 8MM-60CM SUPP PERIPHERAL GRAFT
Device Problem Unraveled Material (1664)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2019
Event Type  malfunction  
Manufacturer Narrative
Trackwise id# (b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.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 use of a reinforced fusion 8mm-60cm supp peripheral graft prosthesis to perform femoro-femoral cross-bridging at the cutting of the prosthesis, part of the prosthesis separates between the ptfe and the polyester.No clinical consequence noted.The other part of the prosthesis is integrates and is posed by the surgeon.
 
Manufacturer Narrative
Trackwise id# (b)(4).The device was returned for evaluation.A follow up report will be submitted when the investigation is completed.
 
Event Description
The hospital reported use of a reinforced fusion 8mm-60cm supp peripheral graft prosthesis to perform femoro-femoral cross-bridging at the cutting of the prosthesis, part of the prosthesis separates between the ptfe and the polyester.No clinical consequence noted.The other part of the prosthesis is integrates and is posed by the surgeon.
 
Manufacturer Narrative
Internal complaint number: tw #(b)(4).The device was returned to the factory on 01/17/2020.An investigation was conducted on 05/13/2020.Signs of clinical use and evidence of blood was observed.Sign of blood was observed in the inner tubing of the fusion graft.Four pieces of fusion graft were returned for evaluation.Two pieces which were small in length were cut at an angle.Both the pieces had no support coil.Delamination of the textile and the eptfe was observed on one of these pieces.The textile layer was completely separated from the eptfe layer.The longer piece had the two ends cut at straight angles.The support coil was intact and no delamination was observed on the piece.Based on the return condition of the device and the evaluation result, the reported complaint is confirmed for the reported failure mode "unraveled material".
 
Event Description
The hospital reported use of a reinforced fusion 8mm-60cm supp peripheral graft prosthesis to perform femoro-femoral cross-bridging at the cutting of the prosthesis, part of the prosthesis separates between the ptfe and the polyester.No clinical consequence noted.T he other part of the prosthesis is integrates and is posed by the surgeon.
 
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Brand Name
FUSION 8MM-60CM 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 Key9459190
MDR Text Key187039507
Report Number2242352-2019-01360
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
PMA/PMN Number
K131778
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 02/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2021
Device Model NumberFUSION 8MM-60CM SUPP PERIPHERAL GRAFT
Device Catalogue NumberVS015030680
Device Lot Number25140173
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2020
Was the Report Sent to FDA? Yes
Date Manufacturer Received05/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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