BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRA PTA CATHETER W/ EMBOLIC CAP

    MDR report key: 2060780 · Received March 10, 2011

    Report

    Report Number
    3008350672-2011-00005
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    Manufacturer
    ANGIOSLIDE LTD.
    Product Code
    LIT
    PMA / PMN Number
    K090364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE CARTON AND POUCH LABELING SHOWS THAT RECOMMENDED GUIDE WIRE SIZE FOR USE WITH DEVICE IS 0.035". A 0.014" GUIDE WIRE WAS UTILIZED DURING THE PORTION OF THIS PROCEDURE WHEN THE INCIDENT OCCURRED. IFU PRECAUTIONARY STATEMENTS: "ALWAYS USE A GUIDE WIRE (0.035") SUPPORT FOR ADVANCEMENT AND RETRIEVAL OF SYSTEM COMPONENTS."

    Description of Event or Problem · 1

    TREATMENT OF LEFT DISTAL SFA WITH CHRONIC TOTAL OCCLUSION AND CALCIFICATION USING 6FR SHEATH AND .014" GUIDE WIRE AND ANGIOSLIDE 4X100 DEVICE. THE DEVICE WAS PREPARED PER IFU INSERTED INTO PATIENT SUCCESSFULLY, BALLOON INFLATED TO 10 ATMS FOR 45 SECONDS. REDUCED TO 2 ATMS AND PARTICLE CAPTURE PROCESS INITIATED. DURING THE CAPTURE PROCESS, THE BALLOON RUPTURED. THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE BUT THE RUPTURED BALLOON GOT CAUGHT ON THE GUIDE WIRE. HE THEN ATTEMPTED TO REMOVE THE GUIDE WIRE AND DEVICE TOGETHER, BUT COULD NOT DUE TO RESISTANCE ENCOUNTERED WITH INTRODUCER SHEATH. THE PHYSICIAN THEN REMOVED SHEATH, DEVICE, AND GUIDE WIRE TOGETHER. PHYSICIAN REINSERTED ANOTHER INTRODUCER AND ANOTHER MFR'S DEVICE IN ORDER TO 'CLEAN UP' THE REGION. NO OTHER INTERVENTION AT THIS POINT. PATIENT RETURNED THE FOLLOWING DAY FOR A FOLLOW UP PROCEDURE USING AN ANGIOSLIDE 5X80 DEVICE WHICH FUNCTIONED AS EXPECTED. THIS COMPLETED THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRA PTA CATHETER W/ EMBOLIC CAP CATHETER, ANGIOPLASTY, PERIPHERAL, TRAN LIT ANGIOSLIDE LTD. 1001-05 90355

    Patients

    Seq Age Sex Outcome Treatment
    1