BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE DESTINATION RENAL GUIDING SHEATH

    MDR report key: 3063507 · Received April 17, 2013

    Report

    Report Number
    1118880-2013-00020
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    K012854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - IS BASED UPON EVALUATION OF USER FACILITY INFORMATION AND THE RETURNED SAMPLE; IS BASED UPON RESERVE SAMPLE TESTING . CONCLUSIONS - ARE BASED UPON EVALUATION OF USER FACILITY INFORMATION AND THE RETURNED SAMPLE; IS BASED UPON RESERVE SAMPLE TESTING. THE INVOLVED DEVICE WAS RETURNED FOR EVALUATION. HOWEVER, THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF PRODUCTION OR COMPLAINT RECORDS. THEREFORE, THE FAILURE INVESTIGATION WAS LIMITED TO ASSESSMENT OF USER FACILITY INFORMATION, THE RETURNED SAMPLE & RETENTION SAMPLES FROM RECENT LOTS OF THE SAME PRODUCT CODE. EXAMINATION OF THE RETURN SAMPLE CONFIRMED: THE SHEATH HAD BEEN STRETCHED WITH THE PLASTIC LAYERS BECOMING SEPARATED IN TWO LOCATIONS ALONG THE DEVICE; THE EDGES OF THE PLASTIC TUBING ADJACENT TO THE POINT OF SEPARATION WERE RAGGED; AND THE INNER COIL WIRE LAYER WAS STRETCHED, BUT REMAINED INTACT CONNECTING THE PORTIONS OF THE PLASTIC SHEATH. EVALUATION OF THE RESERVE SAMPLES CONFIRMED NO EVIDENCE OF ABNORMALITIES OR DEFECTS. TESTING OF THE RESERVE SAMPLES CONFIRMED THAT PERFORMANCE SPECIFICATIONS WERE MET. 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 MOST CONSISTENT WITH THE SHEATH HAVING BEEN DAMAGED AS A RESULT OF CONTINUED ATTEMPTS TO WITHDRAW THE DEVICE AGAINST SIGNIFICANT 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 REMOVAL FOLLOWING AN INTERVENTIONAL PROCEDURE ON A PATIENT WITH "SUBSTANTIAL SCAR TISSUE". FOLLOW-UP COMMUNICATION CONFIRMED THAT: THE SHEATH WAS PLACED INTO THE PATIENT'S LEG AFTER OVERCOMING SOME "STUBBORNNESS"; DURING REMOVAL, THE SHEATH BEGAN TO "STRETCH APART" NEAR THE ACCESS SITE WITH THE DISTAL PORTION REMAINING CONNECTED VIA THE INNER COIL WIRE; THE ENTIRE SHEATH WAS ABLE TO BE REMOVED THROUGH THE ACCESS SITE USING FORCEPS TO GRASP THE DISTAL PORTION AT THE POINT OF SEPARATION; THE INTERVENTIONAL PROCEDURE WAS CONFIRMED TO HAVE BEEN COMPLETED SUCCESSFULLY; AND THERE WAS NO REPORTED IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164537 PINNACLE DESTINATION RENAL GUIDING SHEATH GUIDING SHEATH DYB TERUMO MEDICAL CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR AMPLATZ SUPER STIFF .035 WIRE