BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    MDR report key: 3193075 · Received June 21, 2013

    Report

    Report Number
    3005462046-2013-00037
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    LIT
    PMA / PMN Number
    K100303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT INFO IS UNK. THE HOSPITAL DECLINED TO PROVIDE THE PATIENT INFO. THE ANGIOSCULPT DEVICE, 0.018" GUIDE WIRE AND 0.014" EXTENSION GUIDE WIRE WERE RETURNED FOR EVAL. VISUAL EVAL OF THE ANGIOSCULPT DEVICE FOUND NO UNUSUAL CHARACTERISTICS. THE PROXIMAL END OF THE 0.018" GUIDE WIRE APPEARED CORRODED WITH DIVOTS AND MULTIPLE KINKS OBSERVED. THE 0.014" EXTENSION GUIDE WIRE CONNECTOR WAS NECKED AND BENT, THUS, ADD'L HANDLING DURING LAB ANALYSIS RESULTED IN THE TIP OF THE EXTENSION GUIDE WIRE CONNECTOR TO BREAK. DURING FUNCTIONAL TESTING, THE 0.018" GUIDE WIRE WAS INSERTED THROUGH THE DISTAL TIP WITH NO RESISTANCE. HOWEVER, THE PROXIMAL END OF THE GUIDE WIRE FELT ROUGH AGAINST THE LUMEN WALL DURING RETRACTION. THE 0.014" EXTENSION GUIDE WIRE WAS INSERTED THROUGH THE DISTAL TIP WITH NO RESISTANCE. BASED ON THE LAB ANALYSIS, NO FAILURE WAS DETECTED ON THE ANGIOSCULPT DEVICE. AS A CONSERVATIVE MEASURE AN MDR IS BEING SUBMITTED BECAUSE IT CANNOT BE DETERMINED WITH 100% CERTAINTY IF THE ANGIOSCULPT DEVICE CAUSED OR CONTRIBUTED TO THE SEPARATION OF THE GUIDE WIRE FROM THE EXTENSION GUIDE WIRE. SINCE THIS EVENT OCCURRED OUTSIDE OF THE PATIENT, THERE IS NO RISK OF PATIENT INJURY.

    Description of Event or Problem · 1

    DURING ABOVE-THE-KNEE PERCUTANEOUS PERIPHERAL INTERVENTION, THE CATHETER COULD NOT CROSS THE TIBIAL LESION AND THE 0.014" EXTENSION GUIDE WIRE CAME OFF THE 0.018" GUIDE WIRE. A SJM JACKAL 6.0X 20MM WAS USED AND THE PROCEDURE WAS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283374 ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW) LIT ANGIOSCORE, INC. 2076-6040 F12090025

    Patients

    Seq Age Sex Outcome Treatment
    1 JAPAN LIFELINE- ATHLETE PADDLER| 0.014" X 165 CM EXTENSION GUIDE WIRE| ASAHI INTECC- NEO'S| 0.018" X 165 CM GUIDEWIRE