BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE DESTINATION RENAL GUIDING SHEATH

    MDR report key: 2222894 · Received July 18, 2011

    Report

    Report Number
    1118880-2011-00008
    Event Type
    Malfunction
    Date Received
    July 18, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    K012854
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO RETRIEVE THE DETACHED MATERIAL. RESULTS: BASED UPON EVAL OF RESERVE SAMPLES. CONCLUSION: IS BASED UPON EVAL OF RESERVE SAMPLES. THE INVOLVED DEVICE HAS NOT BEEN RETURNED BY THE USER FACILITY. THEREFORE, THE INVESTIGATION WAS BASED UPON EVAL OF USER FACILITY INFO AND RESERVE SAMPLES. INSPECTION AND TESTING OF REP RETAINED SAMPLES FOUND NO DEFECTS OR ANOMALIES AND PRODUCT PERFORMANCE SPECIFICATIONS WERE MET. A REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS FOR THIS LOT NUMBER. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT NUMBER HAS NOT BEEN REPORTED PREVIOUSLY. UNFORTUNATELY, THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED UPON THE AVAILABLE INFO. THE EVENT DESCRIPTION IS MOST CONSISTENT WITH THE DISTAL PORTION OF THE SHEATH HAVING BEEN CAUGHT WITHIN THE PT'S VASCULATURE, AND THEN, ATTEMPTS TO WITHDRAW THE DEVICE LEADING TO THE REPORTED PARTIAL SEPARATION OF THE SHEATH. THE POTENTIAL OF SUCH AN EVENT IS ADDRESSED IN THE DEVICE LABELING, WHICH STATES 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 INFO HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, AND FOLLOW UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE DISTAL PORTION OF THE GUIDING SHEATH BECAME SEPARATED DURING REMOVAL FOLLOWING AN INTERVENTION PROCEDURE. FOLLOW-UP COMMUNICATION CONFIRMED THAT: DURING REMOVAL OF THE SHEATH FROM THE PT'S LEG, THE SHEATH SEPARATED IN SEVERAL AREAS EXPOSING THE CORE WIRE; THE PHYSICIAN PERFORMED A CUT DOWN PROCEDURE IN ORDER TO SUCCESSFULLY RETRIEVE ALL OF THE DETACHED MATERIAL; PRESSURE WAS HELD ON THE PT'S FEMORAL ARTERY, THEN USED A FEM-STEP TO STOP BLEEDING AT THE ACCESS SITE; AND THE PT WAS REPORTED TO BE "FINE" AFTER THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE DESTINATION RENAL GUIDING SHEATH DYB TERUMO MEDICAL CORPORATION NA NE20

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention