BEUDAMED
    FDA Adverse Event Death Summary report: N

    LINEAR RLM 7.5FR. 40CC IAB

    MDR report key: 3140417 · Received May 29, 2013

    Report

    Report Number
    2248146-2013-00004
    Event Type
    Death
    Date Received
    May 29, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K041281
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND WILL BE SENT FOR SANITIZATION AND EVALUATED UPON RETURN. A REVIEW OF DEVICE HISTORY RECORDS DOES NOT SHOW ANY NON-CONFORMANCES WHICH MIGHT BE CONSIDERED RELATED TO THIS EVENT. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A F/U MEDWATCH WILL BE SUBMITTED WHEN THE DEVICE INVESTIGATION IS COMPLETE. MEANWHILE, IT IS IMPORTANT TO NOTE THAT THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: IN APPENDIX A FACTORS AFFECTING AUGMENTATION, "PHYSIOLOGICAL CONDITIONS CAN CONTRIBUTE TO POOR AUGMENTATION. AMONG THEM ARE: PT'S MEAN ARTERIAL BLOOD PRESSURE IS LOW." IN THIS CASE, THE PT'S BLOOD PRESSURE WAS REPORTED TO BE LOW PRIOR TO THE INITIATION OF THERAPY, AND CONTINUED TO FALL THROUGHOUT THE PROCEDURE, WHICH MAY HAVE CONTRIBUTED TO THE AUGMENTATION ISSUE THAT WAS REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, MEDICAL TREATMENT WAS STARTED ON AN (B)(6) URGENT PT, WITH A BLOOD PRESSURE READING OF 60MMHG. ALTHOUGH THE INTRA-AORTIC BALLOON (IAB) WAS SUCCESSFULLY INSERTED, DURING INITIATION OF THERAPY, THE DISTAL SIDE OF THE BALLOON WAS NOT INFLATING. THIS RESULTED IN SUB-OPTIMAL AUGMENTATION. THE PHYSICIAN REPOSITIONED THE IAB BY MOVING IT TOWARDS THE PT'S ABDOMEN; HOWEVER, THE BALLOON REMAINED IN A SEMI-INFLATED STATE. THE PT'S BLOOD PRESSURE BEGAN TO FALL AS THE PT EXPERIENCED BRADYCARDIA, AT WHICH POINT AN EXTERNAL PACEMAKER WAS USED. THE PT'S BLOOD PRESSURE CONTINUED TO FALL. THE PT THEN EXPERIENCED VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION. WHEN THE PT'S BLOOD PRESSURE DROPPED TO 30MMHG, THE PHYSICIAN BEGAN CARDIAC MASSAGE. AFTER 2 HOURS, THE IAB WAS REMOVED FROM THE PT. THE PT EXPIRED AS A RESULT OF CARDIOGENIC SHOCK. THE DOCTOR FELT THAT THE PT OUTCOME WAS NOT UNANTICIPATED; HOWEVER, THE FACT THAT THE IAB DID NOT FUNCTION AS EXPECTED MAY HAVE CONTRIBUTED TO THE OUTCOME. THE DOCTOR DOES NOT NECESSARILY BELIEVE THAT THE PT'S DEATH IS ATTRIBUTED TO THE IAB FUNCTIONAL FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236531 LINEAR RLM 7.5FR. 40CC IAB INTRA-AORTIC BALLOON DSP DATASCOPE CORP 0684-00-0491 2826

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death