BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8FR - 40 CC FOS

    MDR report key: 1994250 · Received January 14, 2011

    Report

    Report Number
    1219856-2011-00014
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 12, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER DIRECTLY TO THE COMPETENT AUTHORITY (B)(4) THAT IN THE REPORTED EVENT, THE CUSTOMER STATED, "BLOCKING EVENT DURING INSERTION." PER THE RELEVANT DETAILS DURING INSERTION OF CATHETER, THREE PROBLEMS WITH THREE DIFFERENT CONSEQUENCES OCCURRED: THERAPY WAS DELAYED. ANOTHER IAB WAS USED. PT INJURY. THERE WAS NO REPORTED PT DEATH. THE PT WAS INJURED; HOWEVER, IT IS UNK IF THE PT REQUIRED MEDICAL/SURGICAL INTERVENTION. INTRA-AORTIC BALLOON PUMP (IABP) THERAPY WAS DELAYED / INTERRUPTED, LENGTH OF TIME IS LISTED AS UNK. IT IS REPORTED THAT THE MD DID USE A SHEATH AND THE DEVICE WAS REMOVED AND REPLACED. IT IS UNK IF THE INTRA-AORTIC BALLOON (IAB) REPLACEMENT WAS A SUCCESSFUL REPLACEMENT. THERE WERE REPORTED PT COMPLICATIONS. THE PT COMPLICATIONS ARE UNK. THE OUTCOME OF THE PT IS UNK.

    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