BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE DESTINATION RENAL GUIDING SHEATH

    MDR report key: 2981478 · Received February 27, 2013

    Report

    Report Number
    1118880-2013-00008
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    K012854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IS BASED UPON EVALUATION OF USER FACILITY INFORMATION AND PHOTOGRAPHS OF THE INVOLVED SAMPLE; IS BASED UPON RESERVE SAMPLE TESTING. (B)(4) ARE BASED UPON EVALUATION OF USER FACILITY INFORMATION AND PHOTOGRAPHS OF THE INVOLVED SAMPLE; IS BASED UPON RESERVE SAMPLE TESTING. ALTHOUGH THE INVOLVED DEVICE WAS NOT RETURNED BY THE USER FACILITY, PHOTOGRAPHS WERE ABLE TO BE OBTAINED. THEREFORE, THE INVESTIGATION WAS BASED UPON EVALUATION OF USER FACILITY INFORMATION, PHOTOGRAPHS OF THE INVOLVED DEVICE AND REPRESENTATIVE RESERVE SAMPLES FROM THE REPORTED PRODUCT CODE. EXAMINATION OF PHOTOGRAPHS OF THE INVOLVED DEVICE CONFIRMED THAT THE SHEATH TUBING HAD BEEN SEPARATED EXPOSING THE INNER COIL WIRE. THE COIL WIRE APPEARED TO HAVE REMAINED INTACT, BUT SHOWED EVIDENCE OF HAVING BEEN STRETCHED. INSPECTION OF REPRESENTATIVE RETAINED SAMPLES FOUND NO DEFECTS OR ANOMALIES. TESTING OF REPRESENTATIVE RETAINED SAMPLES CONFIRMED THAT PRODUCT PERFORMANCE SPECIFICATIONS WERE MET. ALTHOUGH THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED UPON THE AVAILABLE INFORMATION, THE APPEARANCE OF THE INVOLVED DEVICE IN THE PHOTOGRAPHS IS CONSISTENT WITH THE SHEATH HAVING BEEN DAMAGED AS A RESULT OF CONTINUED ATTEMPTS TO WITHDRAW THE DEVICE AGAINST RESISTANCE. THE RESISTANCE MAY HAVE BEEN RELATED TO THE REPORTED "STEEP CALCIFIED BIFURCATION." THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT BY STATING IN THE INSTRUCTIONS-FOR-USE: "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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE GUIDING SHEATH BECAME PARTIALLY SEPARATED DURING REMOVAL FOLLOWING AN INTERVENTIONAL PROCEDURE IN THE SFA INVOLVING A "STEEP CALCIFIED BIFURCATION". COMMUNICATION WITH THE USER FACILITY INDICATED THE FOLLOWING: THE DEVICE "CAME APART IN THE BODY" UPON REMOVAL; THE PATIENT REQUIRED NO INTERVENTION AS A RESULT OF THE SEPARATION; THE INITIAL PROCEDURE WAS COMPLETED SUCCESSFULLY; AND THE PATIENT WAS REPORTED TO BE "FINE."

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84735 PINNACLE DESTINATION RENAL GUIDING SHEATH GUIDING SHEATH DYB TERUMO MEDICAL CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR