BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA-THIN BALLOON DILATATION CATHETER

    MDR report key: 408161 · Received July 31, 2002

    Report

    Report Number
    6000089-2002-00155
    Event Type
    Injury
    Date Received
    July 31, 2002
    Date of Event
    June 26, 2002
    Report Date
    June 27, 2002
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION, IRELAND, LTD.
    Product Code
    LIT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RENAL ARTERY TREATMENT PROCEDURE, A NIR ROYAL BILIARY STENT WHICH IS PREMOUNTED ON A TALON BALLOON WAS INSERTED THROUGH A CYBER GUIDE CATHETER OVER AN XS TROOPER WIRE. THE STENT WAS DEPLOYED IN THE RENAL ARTERY. HOWEVER, WHEN THE DOCTOR ATTEMPTED TO REMOVE THE BALLOON CATHETER FROM THE STENT HE ENCOUNTERED REMOVAL DIFFICULTIES. HE WAS UNCERTAIN WHETHER THE BALLOON WAS STUCK ON THE STENT OR WHETHER IT COULD NOT BE RETRIEVED THROUGH THE GUIDE CATHETER. THE BALLOON CATHETER AND THE GUIDE CATHETER HAD TO BE REMOVED FROM THE SHEATH TOGETHER. THE DOCTOR NEEDED TO GO BACK IN AND POST DILATE THE STENT TO 8MM SO HE CHOSE THE UT-SDS BALLOON CATHETER AND WENT IN THROUGH THE CYBER GUIDE CATHETER OVER THE TROOPER WIRE AND AGAIN, ON ATTEMPTING REMOVAL, HAD THE SAME DIFFICULTY. AGAIN, THE BALLOON CATHETER AND THE GUIDE CATHETER HAD TO BE FULLY REMOVED FROM THE SHEATH TOGETHER. RESISTANCE WAS FELT IN BOTH INSTANCES AND IT TOOK MORE "TUGGING" THAN NORMAL TO REMOVE THE BALLON. THE STENT WAS PROPERLY POSITIONED AND FULLY DEPLOYED. NO PATIENT PROBLEMS OCCURRED OTHER THAN EXTENDED PROCEDURE TIME.

    Description of Event or Problem · 1

    PREVIOUSLY IT WAS REPORTED AS BEING THE SAME AS MANUFACTURERS REPORT # 6000089-2002-00156 AND 60001093-2002-00088. SHOULD HAVE BEEN REPORTED AS SAME AS MANUFACTURERS REPORT #'S 6000089-2002-00156 ANJD 6000128-2002-00002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-THIN BALLOON DILATATION CATHETER PTA BALLOON DIL CATHETER LIT BOSTON SCIENTIFIC CORPORATION, IRELAND, LTD. NA 4556557

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention