BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRA AORTIC BALLON PUMP

    MDR report key: 12438642 · Received September 7, 2021

    Report

    Report Number
    MW5103751
    Event Type
    Injury
    Date Received
    September 7, 2021
    Date of Event
    May 1, 2021
    Report Date
    September 2, 2021
    Manufacturer
    MAQUET CARDIOVASCULAR US SALES LLC / DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT AWAITING OHT, REQUIRED PLACEMENT OF IABP FOR WORSENING CARDIOGENIC SHOCK. RIGHT AXILLARY IABP PLACED (B)(6) 2021; REMOVED AND REPLACED IN LEFT AXILLARY (B)(6) 2021 DUE TO IAPB RUPTURE. ON (B)(6) 2021, LEFT AXILLARY IABP REMOVED AND REPLACED W/RIGHT FEMORAL IABP DUE TO IABP RUPTURE. ON (B)(6) 2021, PT UNDERWENT OHT. SUBSEQUENTLY DISCHARGED FOR REHAB. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328520 INTRA AORTIC BALLON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP MAQUET CARDIOVASCULAR US SALES LLC / DATASCOPE CORP. 0684-00-0296-01U 3000140264
    1328521 INTRA AORTIC BALLON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP MAQUET CARDIOVASCULAR US SALES LLC / DATASCOPE CORP. 0684-00-0296-01U 3000140264

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention