BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE DESTINATION RENAL GUIDING SHEATH

    MDR report key: 2840568 · Received November 20, 2012

    Report

    Report Number
    1118880-2012-00031
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    K012854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS: ARE BASED UPON EVALUATION OF RETURNED SAMPLE AND USER FACILITY INFORMATION; ARE BASED UPON EVALUATION OF UNDAMAGED SECTIONS OF THE RETURNED SAMPLE. 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 AND THE RETURNED SAMPLE. EXAMINATION OF THE RETURN SAMPLE CONFIRMED: THE SHEATH TIP HAD BEEN DAMAGED AND APPROXIMATELY 11MM OF THE MATERIAL UNRAVELED, BUT REMAINED ATTACHED TO THE DEVICE; AND EXAMINATION AND TESTING OF UNDAMAGED SECTIONS OF THE SHEATH CONFIRMED, THERE WERE NO INDICATIONS OF MALFUNCTION OR PRE-EXISTING DEFECT. ALTHOUGH THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED UPON THE AVAILABLE INFORMATION, THE APPEARANCE OF THE RETURNED SAMPLE IS 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 DAMAGED DURING A PROCEDURE. REPORTEDLY, THE DISTAL END OF THE SHEATH "FRAYED" DURING REMOVAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO ADDITIONAL EVENT SPECIFIC INFORMATION HAS BEEN PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1