BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRA PTA CATHETER W/EMBOLIC CAP

    MDR report key: 1950023 · Received December 6, 2010

    Report

    Report Number
    3008350672-2010-00002
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 10, 2010
    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

    A COMPANY/SALES REP WAS PRESENT DURING THIS CASE AND ADVISED THE PHYSICIAN AGAINST RE-USE OF THE DEVICE, HOWEVER, THE PHYSICIAN RE-USED THE DEVICE MULTIPLE TIMES. ADDITIONALLY, THE IFU, POUCH LABEL, AND CARTON LABEL CLEARLY STATE THAT THE DEVICE IS A SINGLE USE DEVICE. AFTER USING THE DEVICE FOUR TIMES, THE PHYSICIAN COULD NOT DRAW THE DEVICE INTO THE CATHETER SHEATH, AT WHICH TIME, THE COMPANY REP DIRECTED HIM TO FOLLOW THE STEPS IN THE IFU "BALLOON CATHETER OPERATION" SECTION ITEM 6: CAUTIONARY STATEMENT: "CAUTION: IF RESISTANCE MET DURING THE CATHETER WITHDRAWAL THROUGH THE SHEATH, SLIGHTLY ADVANCE THE SHAFT INTO THE INTRODUCER, SLIGHTLY ADVANCE THE PULLING KNOB TOWARD THE HANDLE GRIP, AND RE-ATTEMPT TO WITHDRAW. IF THE BALLOON CANNOT BE WITHDRAWN THROUGH THE SHEATH, WITHDRAW THE CATHETER AND SHEATH AS ONE UNIT." THE PHYSICIAN DID NOT FOLLOW THESE STEPS, RATHER HE INFLATED THE BALLOON TO 16 ATMS, WHICH IS ABOVE THE RATED BURST PRESSURE OF 12 ATMS FOR THE BALLOON, AS STATED IN THE IFU AND ON THE CARTON/POUCH LABELS. THEREFORE, WE HAVE DETERMINED THE INCIDENT DESCRIBED HEREIN TO BE ATTRIBUTED TO USER ERROR AND HAVE ASSIGNED THE RE-USE CODES. NO INJURY OR INTERVENTION TO PREVENT INJURY IS ASSOCIATED WITH THIS REPORT.

    Description of Event or Problem · 1

    THE PHYSICIAN USED A 4X100 DEVICE ON A PERIPHERAL VASCULAR PROCEDURE. THE DEVICE WORKED AS INTENDED DURING INITIAL USE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO REPEAT THE PROCEDURE ON THIS PT BUT HAD NO MORE 4X100 DEVICES AVAILABLE, SO THE PHYSICIAN RE-USED THE SAME DEVICE. A TOTAL OF FOUR PROCEDURES WERE PERFORMED ON THIS PT WITH THE SAME DEVICE. MULTIPLE USE IS IN VIOLATION OF THE IFU. DURING THE FOURTH USE, AFTER INFLATION, DEFLATION, INVERSION AND FURTHER DEFLATION, THE PHYSICIAN COULD NOT DRAW THE DEVICE BACK INTO THE INTRODUCER SHEATH. HE FOLLOWED THE PROCEDURE FOR SITUATIONS LIKE THIS (ADVANCING THE INNER CATHETER, RE-ATTEMPTING REMOVAL, ETC.) WITHOUT SUCCESS. HE DID NOT ATTEMPT TO REMOVE THE INTRODUCER SHEATH AND DEVICE TOGETHER (AS THE IFU INSTRUCTS). INSTEAD, THE BALLOON WAS INFLATED TO 16 ATMS (ABOVE THE RATED BURST PRESSURE STATEMENTS IN IFU AND CARTON/POUCH LABELS) TO PURPOSELY BURST THE BALLOON. AT THIS POINT, HE REMOVED THE DEVICE FROM THE PT. NO INJURY OCCURRED AS A RESULT.

    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 90354

    Patients

    Seq Age Sex Outcome Treatment
    1 Other