BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 1171345 · Received September 22, 2008

    Report

    Report Number
    1219856-2008-00443
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 22, 2008
    Manufacturer
    ARROW INTL, INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: INTRA-AORTIC BALLOON (IAB) WAS RETURNED FOR EVAL. GUIDEWIRES, SHEATH AND PUMP TUBING WERE NOT RETURNED. THERE WAS BLOOD ON ALL EXTERIOR SURFACES OF IAB. IAB WAS SEVERELY BENT AND KINKED AT VARIOUS LOCATIONS THROUGHOUT LENGTH. BLADDER WAS CUT APPROXIMATELY 23 CM FROM DISTAL TIP, APPROX 4.5 CM REMAINING ATTACHED TO CATHETER TIP. APPROXIMATELY 22.7 CM OF BLADDER WAS MISSING AND NOT RETURNED. CENTRAL LUMEN WAS CUT APPROX 14 CM FROM DISTAL TIP, APPROX 8.5 CM OF CENTRAL LUMEN MISSING AND NOT RETURNED. FOS FIBER WAS CUT APPROX 3.7 CM FROM PROXIMAL END OF BLADDER TIP, APPROX 29.8 CM OF FIBER MISSING AND NOT RETURNED. CATHETER WAS ACCORDIANED APPROX 13.5 CM IN LENGTH FROM PROXIMAL END OF BLADDER AND AGAIN APPROX 19 CM FROM PROXIMAL END OF BLADDER; APPROX 2 CM IN LENGTH. CENTRAL LUMEN WAS BENT/KINKED APPROX 22.2 CM AND 24.5 CM ABOVE BIFURCATION AND APPROX 10.5 CM, 11.8 CM AND 13.8 CM ABOVE PROXIMAL END OF BLADDER. THERE WAS APPROX 5 MM OF A GUIDEWIRE PROTRUDING FROM THE LUER END OF IAB. DUE TO THE FACT, THE GUIDEWIRE HAD BEEN CUT, IT UNRAVELED AND BECAUSE OF KINKS IN CENTRAL LUMEN, IT WAS NOT POSSIBLE TO REMOVE FROM IAB. MISSING PORTIONS OF GUIDEWIRE WERE NOT RETURNED. A DHR REVIEW WAS CONDUCTED ON THE IAB AND IT MET ALL SPECIFICATIONS AND PASSED ALL IN-PROCESS TESTING. THERE WERE NO MANUFACTURING ABNORMALITIES ESTABLISHED BETWEEN THE DHR AND THE REPORTED COMPLAINT. DUE TO SEVERELY DAMAGED CONDITION OF RETURNED IAB AND MISSING PIECES, IT WAS NOT POSSIBLE TO EVALUATE CUSTOMER COMPLAINT. A CAPA HAS BEEN INITIATED TO ADDRESS THE ISSUE OF PREMATURE UNWRAPPING OF IAB.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION. THE MD INSERTED THE SHEATH AND WHILE INSERTING THE IAB THROUGH THE SHEATH INTO THE PT, THE MEMBRANE OF THE IAB BEGAN TO UNWRAP. THE MD COULD NOT REMOVE THE IAB WITHOUT DOING A "CUT DOWN." AFTER REMOVING THE IAB FROM THE PT, ANOTHER IAB WAS NOT INSERTED. THE PT EXPIRED TWO HOURS LATER. PER THE MD, THE DEATH WAS NOT ATTRIBUTED TO THE IAB INCIDENT.

    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. MF8050913

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention