BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE DESTINATION RENAL GUIDING SHEATH

    MDR report key: 1646462 · Received March 18, 2010

    Report

    Report Number
    1118880-2010-00004
    Event Type
    Malfunction
    Date Received
    March 18, 2010
    Report Date
    February 18, 2010
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    DYB
    PMA / PMN Number
    K012854
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): RESULT: ARE BASED UPON EVAL OF USER FACILITY INFO AND DEVICE PHOTOGRAPHS; CODE IS BASED UPON EVALUATION OF RESERVE SAMPLES. CONCLUSION CODES ARE BASED UPON EVALUATION OF USER FACILITY INFORMATION AND DEVICE PHOTOGRAPHS; CODE IS BASED UPON EVALUATION OF RESERVE SAMPLES. THE INVOLVED DEVICE WAS NOT RETURNED BY THE USER FACILITY, WHICH LIMITS THE INVESTIGATION. THE INVESTIGATION WAS BASED UPON EVAL OF USER FACILITY INFO, PHOTOGRAPHS OF THE INVOLVED DEVICE AND RESERVE SAMPLES. VISUAL INSPECTION AND FUNCTIONAL TESTING OF RESERVE SAMPLES CONFIRMED NO ABNORMALITIES OR DEFECTS. 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. ALTHOUGH THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED UPON THE AVAILABLE INFO, THE EVENT DESCRIPTION IS CONSISTENT WITH THE SHEATH HAVING BEEN DAMAGED AS A RESULT OF CONTINUED ATTEMPTS TO WITHDRAW THE DEVICE AGAINST RESISTANCE AS WAS CONFIRMED DURING BY THE INVOLVED PHYSICIAN DURING FOLLOW-UP COMMUNICATION. IN ADDITION, THE PHYSICIAN STATED HE IS SATISFIED WITH THE PERFORMANCE OF THE DESTINATION GUIDING SHEATH AND WILL CONTINUE TO USE IT. THE DEVICE LABELING 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, TRENDING , AND FOLLOW UP. (B)(4)

    Description of Event or Problem · 1

    PER THE EVENT DESCRIPTION ON THE ATTACHED USER FACILITY MEDWATCH REPORT # (B)(4): "7FR TERUMO SHEATH BECAME LODGED IN LEFT FEMORAL ARTERY AFTER BREAKING INTO TWO PIECES DURING USE. BOTH PIECES SUCCESSFULLY REMOVED WITHOUT FURTHER COMPLICATIONS." FOLLOW-UP COMMUNICATION WITH THE PHYSICIAN CONFIRMED THAT: THE DEVICE WAS USED FOR A CONTRA-LATERAL APPROACH TO THE LEFT SFA GOING UP AND OVER THE ILIAC ARTERY BIFURCATION, WHERE STENTS HAD BEEN PLACED DURING A PREVIOUS PROCEDURE; DIFFICULTY WAS ENCOUNTERED WHEN TRYING TO ADVANCE THROUGH THE BIFURCATION AND THEN AGAIN DURING THE ATTEMPTS TO REMOVE THE GUIDE SHEATH; AS THE DOCTOR CONTINUED PULLING TO OVERCOME THE RESISTANCE, THE SHEATH SEPARATED INTO TWO SECTIONS, BUT REMAINED CONNECTED BY THE COIL WIRE; THE DETACHED MATERIAL WAS SUCCESSFULLY REMOVED WITH FORCEPS; AND THE PT HAS BEEN DISCHARGED AND IS "DOING WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE DESTINATION RENAL GUIDING SHEATH DYB TERUMO MEDICAL CORP. NA LN11

    Patients

    Seq Age Sex Outcome Treatment
    1 CSI DIAMOND BACK PAD SYSTEM WITH 2.0MM CROWN