BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-THIN SDS BALLOON CATHETER

    MDR report key: 797465 · Received December 13, 2006

    Report

    Report Number
    6000089-2006-02568
    Event Type
    Malfunction
    Date Received
    December 13, 2006
    Date of Event
    November 14, 2006
    Report Date
    November 14, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    k011889
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. A REVIEW OF THE MFG RECORDS FOR BATCH # 830359 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL ANGIOPLASTY TREATMENT PROCEDURE INVOLVING THE COMMON ILIAC, BALLOON WITHDRAWAL DIFFICULTY OCCURRED. ACCORDING TO THE CUSTOMER "DURING THE PROCEDURE, THEY DEPLOYED THE BALLOON INSIDE THE BODY, THEN THEY REMOVED THE BALLOON. WHEN THEY TRIED TO PUT IT BACK IN THROUGH THE SHEATH, IT WOULD NOT GO." THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. PATIENT STATUS IS REPORTED AS "NO COMPLICATIONS." ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-THIN SDS BALLOON CATHETER DQY, CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC NA 8303591

    Patients

    Seq Age Sex Outcome Treatment
    1 *