BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 1022877 · Received March 28, 2008

    Report

    Report Number
    1219856-2008-00156
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    November 6, 2007
    Report Date
    March 28, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    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. DATA KEY AND SLIDE CONNECTOR WERE ATTACHED TO THE FIBER OPTIX SENSOR (FOS) CABLE. SHEATH WAS ON THE BLADDER APPROX 8 CM FROM DISTAL TIP. BLADDER APPEARED TO BE BUNCHED UP IN THE SHEATH APPROX 9 MM FROM THE DISTAL TIP. SHEATH BODY WAS BUCKLED JUST BELOW THE HUB APPROX 2 MM IN LENGTH. IAB WAS BENT/KINKED APPROX 5 MM ABOVE THE BIFURCATION. FOS WAS LIGHT LEVEL TESTED AND PASSED. A DIFFERENT GUIDEWIRE WAS FED THRU THE CENTRAL LUMEN, BUT WOULD NOT PASS THE KINKED AREA OF THE BIFURCATION. IT APPEARED THAT AN ATTEMPT TO REMOVE THE IAB FROM THE SHEATH WAS MADE. THERE WAS BLOOD IN THE FURLS OF THE BLADDER. A VACUUM WAS PULLED ON THE IAB AND HELD. THE IAB WAS SUBMERGED AND PRESSURIZED IN WATER. NO LEAKS WERE DETECTED IN THE IAB OR BLADDER. SHEATH AND BLADDER WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATION. A DEVICE HISTORY REVIEW WAS CONDUCTED ON THE IAB AND IT MET ALL SPECIFICATIONS AND PASSED ALL IN-PROCESS TESTING. IT CANNOT BE DETERMINED WHEN OR HOW THE SLIGHT BUCKLE IN THE SHEATH OCCURRED. NO PROBLEM WAS FOUND WITH THE BALLOON.

    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 FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. MF7097088

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR