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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV FUSION BIOLINE 6MM-40CM SUPP PERIPHERAL; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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MAQUET CV FUSION BIOLINE 6MM-40CM SUPP PERIPHERAL; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER Back to Search Results
Catalog Number VS01503046B0
Device Problem Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/23/2016
Event Type  malfunction  
Manufacturer Narrative
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.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 the fusion bioline would not be a good option for an aorto fem bypass procedure because the rings come off the graft too easily.This is not good for an area that needs the external ring support that the graft is supposed to offer.The hospital felt that the rings should be stronger in their attachment to the graft.Graft was implanted (b)(6) 2015.No reported patient effects.
 
Manufacturer Narrative
(b)(4).The release testing records were reviewed for the bead peal strenght.The graft profile results were also reviewed.There were no non-conformances observed in the bead peel or the graft profile values recorded during release testing.
 
Event Description
The hospital reported that the fusion bioline would not be a good option for an aorto fem bypass procedure because the rings come off the graft too easily.This is not good for an area that needs the external ring support that the graft is supposed to offer.The hospital felt that the rings should be stronger in their attachment to the graft.Graft was implanted (b)(6) 2015.No reported patient effects.
 
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Brand Name
FUSION BIOLINE 6MM-40CM SUPP PERIPHERAL
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 Key5736770
MDR Text Key48565248
Report Number2242352-2016-00567
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131778
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2017
Device Catalogue NumberVS01503046B0
Device Lot Number25100180
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device Age YR
Date Manufacturer Received08/31/2016
Date Device Manufactured06/30/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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