BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 1022876 · Received March 28, 2008

    Report

    Report Number
    1219856-2008-00155
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    November 4, 2007
    Report Date
    March 28, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K040801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER EVALUATION, IT WAS DETERMINED THAT THE EVENT WAS MDR REPORTABLE. EVALUATION: THE INTRA-AORTIC BALLOON (IAB) WAS RETURNED. PUMP TUBING AND GUIDEWIRES WERE NOT RETURNED. THE SHEATH WAS ON THE BLADDER APPROX 4.1 CM FROM THE DISTAL TIP. THE BLADDER WAS STILL FURLED IN THE SHEATH. THERE WAS BLOOD ON THE EXTERIOR SURFACE ON THE IAB AND IN THE FURLS OF THE BLADDER. A VACUUM WAS PULLED ON THE IAB AND HELD. A DIFFERENT GUIDEWIRE WAS FED THRU THE CENTRAL LUMEN WITH NO RESISTANCE. THE SHEATH WAS REMOVED FROM THE IAB FOR FURTHER INVESTIGATION; NO RESISTANCE WAS ENCOUNTERED. THE IAB WAS SLIGHTLY BENT APPROX 12.5 CM FROM THE DISTAL TIP. IAB WAS SUBMERGED AND PRESSURIZED IN WATER. NO LEAKS WERE DETECTED IN THE IAB OR BLADDER. SHEATH AND BLADDER WERE MEASURED AND WITHIN SPECIFICATION. A DEVICE HISTORY RECORD RE-REVIEW WAS CONDUCTED ON THE IAB, AND IT MET ALL SPECIFICATIONS AND PASSED ALL IN-PROCESS TESTING. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CARDIAC CATH LAB, THE MD INSERTED THE SHEATH VIA THE RIGHT FEMORAL ARTERY. THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION AND GIVEN TO THE MD TO INSERT THROUGH THE SHEATH. THE MD COULD NOT ADVANCE THE IAB THROUGH THE SHEATH. AS A RESULT, ANOTHER IAB WAS USED WITH SUCCESS. THERE WERE NO REPORTED PT COMPLICATIONS.

    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. MF7065747

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention