BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL DETACHMENT HANDLE

    MDR report key: 5291625 · Received December 11, 2015

    Report

    Report Number
    3005168196-2015-01269
    Event Type
    Malfunction
    Date Received
    December 11, 2015
    Date of Event
    November 13, 2015
    Report Date
    November 13, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548016139
    PMA / PMN Number
    K151572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1. 3005168196-2015-01264, 2. 3005168196-2015-01265, 3. 3005168196-2015-01266, 4. 3005168196-2015-01267, 5. 3005168196-2015-01268.

    Additional Manufacturer Narrative · 1

    RESULT: THERE WAS NO VISIBLE DAMAGE TO THE EXTERIOR OF THE HANDLE. DURING THE FUNCTIONAL ANALYSIS A PIECE OF PET LOCK WAS FOUND INSIDE THE NOSE CONE OF THE HANDLE. THE HANDLE WAS TESTED FOR THROW AND PULL FORCE AND ACTUATED WITHOUT AN ISSUE. CONCLUSION: EVALUATION OF THE RETURNED DEVICE REVEALED THE NOSE CONE OF THE HANDLE HAD A PIECE OF PET LOCK STUCK INSIDE. THIS PIECE OF PET LOCK WAS REMOVED AND THE HANDLE WAS FUNCTIONALLY TESTED. THE HANDLE WAS FUNCTIONAL, AND NO ISSUES WERE FOUND. THE PET LOCK THAT WAS STUCK INSIDE THE NOSE CONE LIKELY CONTRIBUTED TO THE DIFFICULTIES THAT OCCURRED DURING DETACHMENT. SINCE THE SMART COILS MENTIONED IN THE COMPLAINT WERE NOT RETURNED FOR EVALUATION, THE ROOT CAUSE OF THE PET BECOMING STUCK IN THE NOSE CONE COULD NOT BE DETERMINED. HANDLES ARE 100% FUNCTIONALLY TESTED DURING INCOMING INSPECTION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY DETACHING FIVE SMART COILS IN SEQUENCE USING THE HANDLE; HOWEVER, THE SMART COILS DETACHED AFTER MULTIPLE ATTEMPTS AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819863 PENUMBRA SMART COIL DETACHMENT HANDLE HCG, KRD HCG PENUMBRA, INC. F65232 00814548016139

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR