BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 2061516 · Received March 16, 2011

    Report

    Report Number
    1219856-2011-00098
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    March 5, 2011
    Report Date
    March 16, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K981660
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CVTS OT (CARDIOVASCULAR & THORACIC SURGERY OPERATING THEATER), THE INTRA-AORTIC BALLOON (IAB) CATHETER WAS INSERTED ON (B)(6) 2011. THE SHEATHLESS INSERTION OF THE IAB INTO THE PT THROUGH THE FEMORAL ARTERY WENT SMOOTHLY. X-RAYS WERE PERFORMED UNDER C ARM MACHINE. FIVE MINS AFTER THE IAB INSERTION, THE INTRA-AORTIC BALLOON PUMP (IABP) SHOWED LEAK IN IAB CATHETER & RAPID LOSS OF HELIUM. THE ALARMS OCCURRED AFTER "REPEATED TRIALS." PUMP STRIPS WERE NOT GENERATED. THE PT WAS SICK AND HE NEEDED IABP SUPPORT. THE CVT SURGEON DECIDED TO CHANGE THE IAB CATHETER AND INSERT A DATASCOPE MAGNET LINEAR 7.5 FR 40CC IAB CATHETER. AFTER INSERTION, NO ERROR/ALARMS OCCURRED AND THE IABP WAS RUNNING SMOOTHLY. THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS A TEN MIN DELAY IN IABP THERAPY. THERE WERE NO REPORTED PT COMPLICATIONS. THE PT OUTCOME IS LISTED AS THE PT RECOVERED VERY WELL AND STABLE. ADDITIONAL INFO RECEIVED ON (B)(4) 2011 FROM THE RA/QA MGR STATED THAT THE PUMP USED WAS A DATASCOPE PUMP AND THE PERFUSIONIST USED THE SAME INSERTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. MF9088868

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR DATASCOPE CATHETER| DATASCOPE INTRA-AORTIC BALLOON PUMP