BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 30 CC

    MDR report key: 2193274 · Received July 13, 2011

    Report

    Report Number
    1219856-2011-00249
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED IN THE CATH LAB. PRIOR TO INSERTION, THE PHYSICIAN VACUUMED THE INTRA-AORTIC BALLOON (IAB) INSIDE OF THE TRAY TIGHTLY AND REMOVED IT HORIZONTALLY FROM THE TRAY; HOWEVER, THE IAB LOOSENED WHILE THE PROCEDURE WAS IN PROGRESS. HE COULD NOT ADVANCE THE IAB BECAUSE OF THE UNWRAPPING AND SO HE OPENED ANOTHER KIT AND INSERTED THE IAB SUCCESSFULLY. HE USED THE LEFT FEMORAL ARTERY FOR BOTH INSERTIONS. THERE WERE NO REPORTED PT INJURIES, COMPLICATIONS OR DEATH. THE PT OUTCOME IS NOTED AS FINE. ADD'L INFO RECEIVED ON (B)(4) 2011 FROM THE DISTRIBUTOR INDICATED THE MD USED A TEFLON SHEATH. HE REMOVED THE SHEATH AND CATHETER TOGETHER AND THEN MADE A SECOND SUCCESSFUL INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 30 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK