BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE DESTINATION RENAL GUIDING SHEATH

    MDR report key: 3021162 · Received March 26, 2013

    Report

    Report Number
    1118880-2013-00011
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    K012854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - IS BASED UPON EVALUATION OF RETURNED SAMPLE AND USER FACILITY INFORMATION; IS BASED UPON TESTING OF RESERVE SAMPLES. CONCLUSIONS - IS BASED UPON EVALUATION OF RETURNED SAMPLE AND USER FACILITY INFORMATION; IS BASED UPON TESTING OF RESERVE SAMPLES EVALUATION OF UNDAMAGED SECTIONS OF THE RETURNED SAMPLE THE INVOLVED DEVICE WAS RETURNED AND EVALUATED. EXAMINATION CONFIRMED: (1) THE PLASTIC SHEATH HAD BEEN SEVERELY STRETCHED PRIOR TO BEING TORN; (2) BOTH THE INNER AND OUTER LAYERS OF THE SHEATH WERE SEPARATED, EXPOSING THE COIL WIRE; AND (3) THE COIL WIRE HAD BEEN STRETCHED, ALSO, BUT REMAINED INTACT. EXAMINATION OF RESERVE SAMPLES FROM THE REPORTED LOT, THE PREVIOUS LOT AND THE SUBSEQUENT LOT CONFIRMED NO EVIDENCE OF ABNORMALITIES OR DEFECTS. TESTING OF THE RESERVE SAMPLES CONFIRMED THAT PERFORMANCE SPECIFICATIONS WERE MET. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT HAS NOT BEEN REPORTED PREVIOUSLY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS FOR THIS LOT NUMBER. ALTHOUGH THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED UPON THE AVAILABLE INFORMATION, THE EVENT DESCRIPTION AND APPEARANCE OF THE RETURNED SAMPLE ARE CONSISTENT WITH THE SHEATH HAVING BEEN DAMAGED AS A RESULT OF CONTINUED ATTEMPTS TO MANIPULATE THE DEVICE AGAINST RESISTANCE. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE INSTRUCTIONS-FOR-USE, WHICH STATES: "ADVANCE OR WITHDRAW THE SHEATH SLOWLY. IF RESISTANCE IS MET, DO NOT ADVANCE OR WITHDRAW THE SHEATH UNTIL THE CAUSE OF RESISTANCE HAS BEEN DETERMINED." ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A PORTION OF THE GUIDING SHEATH BECAME SEPARATED DURING A SFA CROSSOVER PROCEDURE. FOLLOW-UP COMMUNICATION CONFIRMED THAT: (1) THE SHEATH WAS PLACED INTO THE RIGHT FEMORAL ARTERY; (2) RESISTANCE WAS ENCOUNTERED DURING ATTEMPTS TO CROSSOVER THE ILIAC ARCH; (3) REPORTEDLY, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE FOLLOWING SUCCESSFUL PLACEMENT OF THE STENT IT WAS NOTED THAT THE "OUTER LAYER PEELED OFF;" (4) THE DETACHED PORTION OF THE DEVICE WAS RETRIEVED FROM THE PUNCTURE SITE USING A SNARE; (5) THE ENTIRE SHEATH WAS ABLE TO BE REMOVED FROM THE PATIENT; (6) THE INITIAL PROCEDURE WAS COMPLETED SUCCESSFULLY; AND (7) THERE WAS NO REPORTED IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124112 PINNACLE DESTINATION RENAL GUIDING SHEATH GUIDING SHEATH DYB TERUMO MEDICAL CORPORATION NA PA04

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR GUIDEWIRE| SNARE