BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOSAVE HYBRID

    MDR report key: 10143730 · Received June 11, 2020

    Report

    Report Number
    2249723-2020-00898
    Event Type
    Injury
    Date Received
    June 11, 2020
    Date of Event
    May 21, 2020
    Report Date
    July 23, 2020
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: PMA/510(K)# FROM: UNKNOWN TO: K112372.

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER INTRA-AORTIC BALLOON PUMP (IABP) THERAPY ENDED, THE CLINICAL TEAM REMOVED THE BALLOON CATHETER FROM THE PATIENT ARTERY AND TORE THE FEMORAL ARTERY. THEY EMERGENTLY MOVED THE PATIENT TO THE OPERATING ROOM TO CONTROL THE SITUATION AND COMPLETE REMOVAL OF THE BALLOON. AFTER REMOVING THE BALLOON CATHETER, THE TEAM IS DESCRIBING THAT THE TIP OF THE BALLOON CATHETER WAS MELTED. THE BALLOON CATHETER WAS NOT REPLACED. INDICATION FOR USE OF THE IABP THERAPY WAS TO WEAN THE PATIENT FROM CARDIOPULMONARY BYPASS. NO PATIENT DEATH OCCURRED. PLEASE REFER TO MFG REPORT NUMBER 2248146-2020-00282 FOR INFORMATION ON THE INVOLVED BALLOON CATHETER.

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER INTRA-AORTIC BALLOON PUMP (IABP) THERAPY ENDED, THE CLINICAL TEAM REMOVED THE BALLOON CATHETER FROM THE PATIENT ARTERY AND TORE THE FEMORAL ARTERY. THEY EMERGENTLY MOVED THE PATIENT TO THE OPERATING ROOM TO CONTROL THE SITUATION AND COMPLETE REMOVAL OF THE BALLOON. AFTER REMOVING THE BALLOON CATHETER, THE TEAM IS DESCRIBING THAT THE TIP OF THE BALLOON CATHETER WAS MELTED. THE BALLOON CATHETER WAS NOT REPLACED. INDICATION FOR USE OF THE IABP THERAPY WAS TO WEAN THE PATIENT FROM CARDIOPULMONARY BYPASS. NO PATIENT DEATH OCCURRED. PLEASE REFER TO MFG REPORT NUMBER 2248146-2020-00282 FOR INFORMATION ON THE INVOLVED BALLOON CATHETER.

    Additional Manufacturer Narrative · 1

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS IABP UNIT CANNOT BE REVIEWED PER THE SOP SINCE THE SERIAL NUMBER FOR THE UNIT WAS NOT PROVIDED. THERE WAS NO REPORTED MALFUNCTION OF THE INVOLVED IABP, AND THE SERIAL NUMBER WAS NOT PROVIDED TO US. HOWEVER, UPON INVESTIGATION, WE WERE ADVISED THAT THE THERAPY WAS TERMINATED PRIOR TO REMOVING THE BALLOON, THUS THE IABP WAS STOPPED PRIOR TO REMOVING THE BALLOON. IN ADDITION, THE PERFUSIONIST STATED THAT THE IABP WAS NOT IN THE OR WHEN THEY WERE ADDRESSING THE SITUATION. NO FURTHER INVESTIGATION IS REQUIRED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER INTRA-AORTIC BALLOON PUMP (IABP) THERAPY ENDED, THE CLINICAL TEAM REMOVED THE BALLOON CATHETER FROM THE PATIENT ARTERY AND TORE THE FEMORAL ARTERY. THEY EMERGENTLY MOVED THE PATIENT TO THE OPERATING ROOM TO CONTROL THE SITUATION AND COMPLETE REMOVAL OF THE BALLOON. AFTER REMOVING THE BALLOON CATHETER, THE TEAM IS DESCRIBING THAT THE TIP OF THE BALLOON CATHETER WAS MELTED. THE BALLOON CATHETER WAS NOT REPLACED. INDICATION FOR USE OF THE IABP THERAPY WAS TO WEAN THE PATIENT FROM CARDIOPULMONARY BYPASS. NO PATIENT DEATH OCCURRED. PLEASE REFER TO MFG REPORT NUMBER 2248146-2020-00282 FOR INFORMATION ON THE INVOLVED BALLOON CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609789 CARDIOSAVE HYBRID SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other IAB SENSATION 34CC| IAB SENSATION 34CC| IAB SENSATION 34CC| IAB SENSATION 34CC