BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-THIN SDS BALLOON CATHETER

    MDR report key: 918660 · Received March 27, 2007

    Report

    Report Number
    6000089-2007-00461
    Event Type
    Malfunction
    Date Received
    March 27, 2007
    Date of Event
    February 22, 2007
    Report Date
    February 26, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DQY
    PMA / PMN Number
    K011889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K) #: K011909.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR AN ARM DECLOTTING TREATMENT PROCEDURE, BALLOON DETACHMENT DIFFICULTIES WERE ENCOUNTERED. THE CUSTOMER STATED THAT "WHEN THEY REMOVED THE BALLOON SHAPING [FOLDING] TOOL, THE BALLOON CAME OFF THE SHAFT OF THE CATHETER. USED ANOTHER ONE SUCCESSFULLY." NO PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-THIN SDS BALLOON CATHETER DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORP. NA 9367496

    Patients

    Seq Age Sex Outcome Treatment
    1 *