BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-THIN SDS BALLOON CATHETER

    MDR report key: 802810 · Received December 28, 2006

    Report

    Report Number
    6000089-2006-02654
    Event Type
    Malfunction
    Date Received
    December 28, 2006
    Date of Event
    November 30, 2006
    Report Date
    December 1, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    k011889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS AS OF THE DATE OF THIS REPORT. 510(K)# K011909.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BILIARY ANGIOPLASTY AND STENTING TREATMENT PROCEDURE, BALLOON REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE CUSTOMER STATED THAT, AFTER DILATATION ANGIOPLASTY AND WHILE "WITHDRAWING THE BALLOON FROM THE PATIENT, RESISTANCE WAS FELT AND THE PHYSICIAN USED SOME EXTRA STRENGTH TO WITHDRAW THE BALLOON" FROM THE 6F INTRODUCER SHEATH. THE "BALLOON CATHETER SHAFT BROKE IN TWO PIECES; IT BROKE APPROX 1 CM PROXIMAL FROM THE PROXIMAL BALLOON MARKER." THE ENTIRE INTRODUCER SHEATH WAS WITHDRAWN. AFTER REMOVAL, THE PHYSICIAN COULD SEE THAT THE DISTAL PART OF THE BALLOON WAS NOT TOTALLY RE-WRAPPED AND HAD CAUSED THE STICKING IN THE INTRODUCER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THIS DEVICE WITHOUT PATIENT COMPLICATIONS. CURRENT PATIENT STATUS IS REPORTED AS "OKAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-THIN SDS BALLOON CATHETER DQY CATHETER, PERCUTANEOUS FGE BOSTON SCIENTIFIC CORPORATION NA 8495830

    Patients

    Seq Age Sex Outcome Treatment
    1 *