BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERLING MONORAIL

    MDR report key: 1241059 · Received November 20, 2008

    Report

    Report Number
    2134265-2008-04414
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    September 17, 2008
    Report Date
    October 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DILATATION OF A DIALYSIS SHUNT, A BALLOON RUPTURE OCCURRED. THE DIALYSIS SHUNT WAS IN THE LEFT ARM. THE VESSEL WAS MILDLY TORTUOUS. THE LESION WAS 70% STENOSED AND NOT CALCIFIED. THE STERLING 8.0 X 40MM/135 CM 4FRENCH BALLOON CATHETER WAS ADVANCED TO THE SITE. THE BALLOON WAS INFLATED TWO TIMES FOR 30 SECONDS AT 8ATM. THE BALLOON RUPTURED DURING WITHDRAWAL OF THE CATHETER, A CIRCUMFERENTIAL TEAR WAS REPORTED. FORCEPS WERE USED TO REMOVE THE REMAINDER OF THE CATHETER. THE ENTIRE BALLOON WAS REMOVED FROM THE PT. THE DILATATION OF THE HEMODIALYSIS SHUNT WAS SUCCESSFUL. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PT'S CURRENT STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING MONORAIL DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC NA 11233036

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention