BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB:8FR - 40 CC FOS

    MDR report key: 1832089 · Received September 3, 2010

    Report

    Report Number
    1219856-2010-00590
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 31, 2010
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CATH LAB THE FIBEROPTIX SENSOR (FOS) WAS INITIALLY CONNECTED TO THE INTRA-AORTIC BALLOON PUMP (IABP) AND THERE WAS NO RECOGNITION OF FOS; MD CONTINUED WITH INSERTION REGARDLESS. THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED THROUGH A SHEATH INTO THE PTS' FEMORAL ARTERY. UPON STARTING IABP, KINKED LINE ALARMS OCCURRED. THE FLUOROSCOPY SHOWED THAT THE IAB HAD UNWRAPPED AND THAT THERE WERE NO VISIBLE KINKS IN PT. AS A RESULT, THE IAB AND SHEATH WERE REMOVED AND REPLACED. THE CATH LAB MANAGER MENTIONED THAT "ALTHOUGH THE GAS LINE WAS NOT VISIBLY KINKED OUTSIDE PT, IT WAS DRAPED ACROSS PT AND MADE SEVERAL TURNS TO THE IABP WHICH COULD HAVE BEEN CONTRIBUTING." THERE WAS NO REPORTED PT DEATH OR INJURY. THERE WAS AN INTERRUPTION IN THERAPY BECAUSE THE IABP WAS UNABLE TO PUMP DUE TO THE "KINKED LINE ALARM." MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THE OUTCOME OF THE PT IS LISTED AS "OK." ADDITIONAL INFO RECEIVED ON 08/26/2010 BY THE SALES REPRESENTATIVE STATED THAT THE SAME INSERTION SITE WAS USED FOR THE SECOND IAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB:8FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTERNATIONAL INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INTRA-AORTIC BALLOON PUMP