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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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MAQUET CARDIOVASCULAR LLC SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Lot Number 3000069363
Device Problems Break (1069); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 06/29/2020
Event Type  malfunction  
Event Description
The information reported was that the inner lumen of the micro puncture sheath had a device failure and sheared with iabp attempt. It is reported that it developed a puncture as it was being inserted. When the device failed, the patient was brought back to the cath lab and the balloon replaced. The entire system was removed and not retained in the body.
 
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Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
MAQUET CARDIOVASCULAR LLC
45 barbour pond rd
wayne NJ 07470
MDR Report Key10902666
MDR Text Key218195648
Report Number10902666
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/25/2020,08/31/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number3000069363
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/25/2020
Event Location Hospital
Date Report to Manufacturer11/25/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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