BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOSCULPT PTCA SCORING BALLOON CATHETER (EX)

    MDR report key: 2010675 · Received February 24, 2011

    Report

    Report Number
    3005462046-2011-00008
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    NWX
    PMA / PMN Number
    P050018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: LABORATORY EVALUATION OF THE RETURNED ANGIOSCULPT EX CATHETER WAS PERFORMED. BOTH THE DISTAL PORTION OF THE CATHETER SHAFT AND THE PROXIMAL PORTION OF THE CATHETER SHAFT WERE RETURNED TO ANGIOSCORE. IT WAS OBSERVED THAT THE DISTAL CATHETER SHAFT SEPARATED ON THE HYPOTUBE, PROXIMAL TO THE HYPOTUBE/DISTAL SHAFT JUNCTION. THE CATHETER SHAFT SHOWED EVIDENCE OF NECKING IN THE HYPOTUBE REGION. RESULTS: RETAINED DEVICE COMPONENTS IS A POTENTIAL ADVERSE EFFECT OF CORONARY ANGIOPLASTY PROCEDURES AND IS LISTED IN THE ANGIOSCULPT DEVICE IFU.

    Description of Event or Problem · 1

    A 3.0 X 10 MM ANGIOSCULPT EX DEVICE WAS UTILIZED FOR ATTEMPTED TREATMENT OF IN-STENT RESTENOSIS (ISR) IN THE MID TO DISTAL LEFT CIRCUMFLEX (LCX) CORONARY ARTERY. THE ANGIOSCULPT CATHETER COULD NOT BE DELIVERED COMPLETELY THROUGH THE TARGET LESION. THE CLINICIAN THEREFORE, DECIDED TO RETRACT THE ANGIOSCULPT DEVICE AND NOTICED THAT DURING WITHDRAWAL OF THE CATHETER SHAFT, THE BALLOON REMAINED STATIONARY. FURTHER WITHDRAWAL OF THE CATHETER SHAFT REVEALED A CATHETER SHAFT SEPARATION. A SECOND GUIDE WIRE (0.014" CHOICE PT) WAS THEN PASSED ALONGSIDE HE ORIGINAL GUIDE WIRE (0.014" COUGAR XT) AND OVER THAT A 1.5 X 10 MM CORDIS FIRE STAR BALLOON WAS ADVANCED TO THE AREA OF THE ANGIOSCULPT BALLOON/SCORING ELEMENT. THE 1.5 X 10 MM CORDIS FIRE START BALLOON WAS INFLATED, THEREBY FREEING UP THE ANGIOSCULPT AND AIDING IN ITS RETRACTION OUT OF THE CORONARY ARTERY. ALL GUIDE WIRES, BALLOONS AND THE GUIDING CATHETER WERE THEN SUCCESSFULLY REMOVED FROM THE PT. THE CLINICIAN COMPLETED THE PROCEDURE BY REPLACING THE GUIDING CATHETER AND GUIDE WIRE, USING CONVENTIONAL BALLOONS AND DEPLOYING AN ENDEAVOR 2.5 X 18 MM DRUG-ELUTING STENT (DES). BASED ON ANGIOSCORE'S REVIEW OF THE CATHETERIZATION PROCEDURE LOG AND PROCEDURAL ANGIOGRAM THAT WERE PROVIDED BY THE HOSPITAL, THERE WAS NO REPORTED VESSEL INJURY OR PT COMPLICATION RESULTING FROM THE CATHETER SHAFT SEPARATION. PT WAS DISCHARGED FROM THE HOSPITAL UNEVENTFULLY POST PROCEDURE AND THERE WAS NO REPORTED PROLONGED HOSPITALIZATION REQUIRED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOSCULPT PTCA SCORING BALLOON CATHETER (EX) NWX ANGIOSCORE, INC. 2034-3010 F09100031

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention 0.014" COUGAR XT GUIDE WIRE