BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 7.5 FR - 40 CC

    MDR report key: 4152518 · Received October 6, 2014

    Report

    Report Number
    1219856-2014-00190
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 9, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE DOCTOR INSERTED THE IAB-06840-U THROUGH THE SHEATH VIA LEFT FEMORAL ARTERY WITHOUT ISSUE. IMMEDIATELY AFTER PLACEMENT, IT INFLATED WITHOUT FAULT ON THE SCREEN. WHEN REBOOTING IN THE INTENSIVE CARE UNIT, AFTER SHUTOFF, THE IAB DID NOT INFLATE. AS A RESULT, THE IAB WAS REMOVED. A NEW KIT WAS RETRIEVED. THERE WAS NO REPORT OF PT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO DELAY IN THERAPY NOTED. THE PT WAS ALIVE. IT WAS NOTED THAT THE INTRA-AORTIC BALLOON PUMP USED DURING THIS EVENT WAS AN AUTOCAT2 WAVE, SN (B)(4). REFERENCE MDR 1219856-2014-00189 FOR THE SECOND EVENT INVOLVING THE SAME PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622118 IAB: 7.5 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. 18F14A0013

    Patients

    Seq Age Sex Outcome Treatment
    1