BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 30 CC FOS

    MDR report key: 1022879 · Received March 28, 2008

    Report

    Report Number
    1219856-2008-00154
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    September 23, 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
    GM
    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. GUIDEWIRE WAS NOT RETURNED. THERE WAS BLOOD ON EXTERIOR SURFACE OF IAB. THE SHEATH WAS ON THE CATHETER SHAFT APPROX 19 CM FROM THE PROXIMAL END OF THE BLADDER. THERE WAS A BEND IN THE CENTRAL LUMEN APPROX 13 CM FROM THE DISTAL TIP. THE PUMP TUBING WAS ATTACHED TO THE LOCK CONNECTOR. THE ONE-WAY VALVE WAS TETHERED TO THE IAB. THE SLIDE CONNECTOR AND CAL-KEY WERE ATTACHED TO THE FIBER OPTIX SENSOR (FOS) CABLE. THE FOS WAS LIGHT LEVEL TESTED AND FAILED, INDICATING A BROKEN FOS. THE CAL-KEY WAS TESTED SEPARATELY AND PASSED. A VACUUM WAS PULLED ON THE IAB, BUT DID NOT HOLD. A VACUUM WAS THEN PULLED ON THE ONE-WAY VALVE AND IT HELD. A DIFFERENT GUIDEWIRE WAS FED THRU THE CENTRAL LUMEN WITH SLIGHT RESISTANCE AT THE BEND. THE IAB WAS SUBMERGED AND PRESSURIZED IN WATER. A GROSS LEAK WAS DETECTED AT THE FOS/BIFURCATION JUNCTION. THE BIFURCATION WAS EXAMINED UNDER MAGNIFICATION. IT APPEARS THAT THE BOND WAS COMPROMISED. A DEVICE HISTORY RECORD RE-REVIEW WAS CONDUCTED ON THE IAB, AND IT MET ALL SPECIFICATIONS AND PASSED ALL IN-PROCESS TESTING. THE CAUSE OF THE REPORTED COMPLAINT WAS DUE TO THE LEAK AT THE FOS/BIFURCATION JUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CATH LAB, THE MD INSERTED A SHEATH VIA THE "RIGHT". THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION AND THE MD INSERTED IT WITHOUT INCIDENCE. EIGHT HOURS LATER, THE PUMP, AUTOCAT 2 WAVE ALARMED "HELIUM LEAK." THE PT WAS "WEANED AND THE IAB WAS EXPLANTED." THE MD NOTICED THAT THERE WAS A LEAK AT THE BIFURCATION. ANOTHER IAB WAS NOT INSERTED BECAUSE THE PT WAS STABLE. THERE WERE NO REPORTED PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 30 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. MF7076095

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR