BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-THIN SDS BALLOON CATHETER

    MDR report key: 796508 · Received December 8, 2006

    Report

    Report Number
    6000089-2006-02533
    Event Type
    Malfunction
    Date Received
    December 8, 2006
    Date of Event
    November 8, 2006
    Report Date
    November 9, 2006
    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

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS AS OF THE DATE OF THIS REPORT. ADDITIONAL PMA 510(K)# K011889.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FEMORAL ARTERY ANGIOPLASTY TREATMENT PROCEDURE, BALLOON REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE CUSTOMER STATED THAT, "DURING WITHDRAWAL, THE WHOLE BALLOON SEGMENT CAME OFF FROM THE CATHETER UPON REMOVAL THROUGH A 6F SHEATH. BALLOON IS LODGED IN THE DISTAL END OF THE SHEATH." IT WAS FURTHER REPORTED THAT AN OVER-THE-WIRE PIN PULL TECHNIQUE WAS USED TO RETRIEVE THE BALLOON AND THE ENTIRE SEGMENT WAS SUCCESSFULLY REMOVED. THE PT WAS ASYMPTOMATIC DURING THIS EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE WITH NO PT INJURIES OR COMPLICATIONS. PT STATUS IS REPORTED AS "FINE."

    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 0008580609

    Patients

    Seq Age Sex Outcome Treatment
    1 *