BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOXCROSS PTA CATHETER

    MDR report key: 1542687 · Received November 17, 2009

    Report

    Report Number
    9710478-2009-00131
    Event Type
    Malfunction
    Date Received
    November 17, 2009
    Date of Event
    October 28, 2009
    Report Date
    October 29, 2009
    Manufacturer
    ABBOTT VASCULAR SWITZERLAND
    Product Code
    LIT
    PMA / PMN Number
    K092286
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). DEVICE #1 - FOXCROSS DILATATION CATHETER; PART# 10308-60, LOT# 620109, IS BEING FILED UNDER A MEDWATCH REPORT # 9710478-2009-00130. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVAL. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADD'L RELEVANT INFO.

    Description of Event or Problem · 1

    DEVICE #2 MALFUNCTION: BALLOON RUPTURE. TIME OF MALFUNCTION: DURING PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING PRE-DILATATION OF THE MILDLY TORTUOUS COMMON BILE DUCT, THE 8X60 FOXCROSS BALLOON WAS INFLATED BY HAND AND RUPTURED. A SECOND 6X40 FOXCROSS BALLOON WAS INTRODUCED INTO THE ANATOMY AND ALSO RUPTURED DURING INFLATION. NO INFLATION DEVICE WAS USED DURING INFLATION OF EITHER BALLOON AND THE INFLATION PRESSURES ARE UNK. DILATATION WAS SUCCESSFULLY COMPLETED USING A THIRD FOXCROSS BALLOON. THERE WAS NO ADVERSE PT EFFECT. THOUGH REQUESTED, NO ADD'L INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOXCROSS PTA CATHETER LIT ABBOTT VASCULAR SWITZERLAND NA 607468

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR DEVICE #1 FOX CROSS DILATATION CATHETER