BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB: 7.5FR - 40 CC

    MDR report key: 2960535 · Received February 12, 2013

    Report

    Report Number
    1219856-2013-00032
    Event Type
    Injury
    Date Received
    February 12, 2013
    Date of Event
    January 25, 2013
    Report Date
    February 12, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Adverse Event
    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 HAS BEEN REPORTED THAT THE EVENT INVOLVED A FEMALE PATIENT WHILE IN THE CARDIOVASCULAR SURGICAL INTENSIVE CARE UNIT (CVSICU) DURING USE. EIGHT DAYS AFTER THE VASCULAR SURGEON INSERTED THE INTRA-AORTIC BALLOON (IAB) THROUGH THE SHEATH VIA LEFT FEMORAL ARTERY, THE PUMP ALARMED HELIUM LEAD AND BLOOD WAS OBSERVED IN THE DRIVELINE TUBING. AS A RESULT, THE IAB AND SHEATH WERE REMOVED AS ONE UNIT SUCCESSFULLY. A NEW IAB WAS INSERTED THROUGH THE SHEATH VIA A NEW INSERTION SITE (RIGHT FEMORAL ARTERY) SUCCESSFULLY. THERE WERE PUMP STRIPS GENERATED AND THE LAST X-RAY WAS AFTER THE INSERTION. THERE WAS NO REPORT OF PATIENT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS AN APPROXIMATE 30 MINUTE DELAY OR INTERRUPTION IN THERAPY WITH NO HARM TO THE PATIENT NOTED. THE PATIENT OUTCOME IS THE PATIENT WAS NOT INJURED, NOR DID THEY EXPIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS NOTED THAT THE INTRA-AORTIC BALLOON PUMP USED WA A MAQUET, MODEL CS100.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61278 IAB: 7.5FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other MAQUET INTRA-AORTIC BALLOON PUMP