BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-THIN SDS BALLOON CATHETER

    MDR report key: 845908 · Received March 5, 2007

    Report

    Report Number
    6000089-2007-00335
    Event Type
    Malfunction
    Date Received
    March 5, 2007
    Date of Event
    February 1, 2007
    Report Date
    February 5, 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

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS AS OF THE DATE OF THIS REPORT. K011909.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY TREATMENT PROCEDURE OF THE ARM, BALLOON SHAFT FRACTURE DIFFICULTIES WERE ENCOUNTERED. THE CUSTOMER STATED THAT, "WHEN WITHDRAWING THE BALLOON THROUGH THE SHEATH, THE BALLOON IN THE UNDERLINE SHAFT BROKE SEPARATING FROM THE PROXIMAL SHAFT. THE BALLOON AND THE SHAFT AND THE SHEATH WERE REMOVED AS A SYSTEM AND THERE WERE NOT PATIENT COMPLICATIONS. PATIENT IS FINE." THE PHYSICIAN DID NOT HAVE ANY DIFFICULTY INFLATING THE BALLOON, AND WAS ABLE TO INFLATE THE BALLOON ON THE FIRST ATTEMPT. THE BALLOON WAS INFLATED TO 18ATMS. THE PHYSICIAN DID NOT HAVE ANY DIFFICULTY DEFLATING THE BALLOON, AND THE BALLOON DID NOT BURST PRIOR TO DETACHMENT.

    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 9186820

    Patients

    Seq Age Sex Outcome Treatment
    1 * STARTER BENTSON 150CM GUIDE WIRE