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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC COOLEY GRAFT; VASCULAR GRAFTS

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MAQUET CARDIOVASCULAR, LLC COOLEY GRAFT; VASCULAR GRAFTS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description
Physician asked for information on the life span of a graft as there was a failure (weeping or something) of an implant that had been implanted about twenty years ago.The product manager is not sure if it is a cooley graft or a competitor graft.The physician is checking on what graft was implanted.
 
Manufacturer Narrative
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.(b)(4).
 
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Brand Name
COOLEY GRAFT
Type of Device
VASCULAR GRAFTS
Manufacturer (Section D)
MAQUET CARDIOVASCULAR, LLC
wayne NJ
Manufacturer (Section G)
MAQUET CARDIOVASCULAR, LLC
45 barbour pond drive
wayne NJ 07470
Manufacturer Contact
tina evancho
45 barbour pond drive
wayne, NJ 07470
9737097265
MDR Report Key4360176
MDR Text Key19611658
Report Number2242352-2014-01401
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Type of Report Initial
Report Date 11/20/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/20/2014
Initial Date FDA Received12/19/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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