BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 7 FR - 30 CC

    MDR report key: 2150522 · Received June 22, 2011

    Report

    Report Number
    1219856-2011-00221
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 21, 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
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CATH LAB THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED BY THE VASCULAR SURGEON (VS). AFTER THE IAB WAS PLACED, THE VS FOUND THAT THE TIP OF THE BALLOON DID NOT INFLATE UNDER THE FLUOROSCOPY. THE VS TRIED TO ADJUST THE IAB, BUT THE TIP OF THE BALLOON STILL WAS UNABLE TO FULLY INFLATE. A "HIGH BASELINE" ALARM OCCURRED. AS A RESULT, THE IAB WAS REMOVED AND A NEW KIT WAS OPENED AND USED WITH SUCCESS. X-RAYS ARE AVAILABLE FOR REVIEW. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO DELAY OR INTERRUPTION OF THERAPY. THERE WAS NO REPORT OF PATIENT DEATH, COMPLICATIONS OR INJURY. THE PATIENT OUTCOME IS THE PATIENT IS FINE. IT WAS NOTED THAT ARROW INTRA-AORTIC BALLOON PUMP (IABP) SERIAL NUMBER (B)(4) WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 7 FR - 30 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR IABP