BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 3873057 · Received June 13, 2014

    Report

    Report Number
    3005168196-2014-00380
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 16, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE PUSHER ASSEMBLY PROXIMAL PET-LOCK IS STILL INTACT INDICATING THAT THE COIL WAS NOT DETACHED AS INTENDED. THE PROXIMAL END OF THE PUSHER ASSEMBLY HYPOTUBE IS SLIGHTLY KINKED APPROXIMATELY 5.0 CM FROM THE PROXIMAL END. THE DISTAL DETACHMENT TIP (DDT) STILL CONTAINS THE COIL PROXIMAL CONSTRAINT BALL AND A PIECE OF BROKEN STRETCH RESISTANT (SR) WIRE. CONCLUSION: THE COMPLIANT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT THE COIL DETACHED BEFORE INTENDED. EVALUATION OF THE RETURNED DEVICE CONFIRMED AN UNINTENTIONAL DETACHMENT. THE COIL PROXIMAL CONSTRAINT BALL IS STILL INSIDE THE DDT AND THE COIL IS DETACHED. IN ADDITION, THE PET-LOCK IS STILL INTACT. THE PUSHER ASSEMBLY HYPOTUBE IS SLIGHTLY KINKED APPROXIMATELY 5.0 CM FROM THE PROXIMAL END OF THE PUSHER HOWEVER THIS IS LIKELY RELATED TO POST-PROCEDURAL HANDLING AND NOT TO THE DEVICE ISSUE. IT APPEARS THAT DURING THE MANIPULATION IN THE PATIENT, THE COIL WAS MANIPULATED WITH FORCE IN EXCESS OF THE TENSILE STRENGTH OF THE SR WIRE MATERIAL, CAUSING THE WIRE TO FRACTURE AND THE COIL TO DETACH. 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 AN EMBOLIZATION PROCEDURE USING A PENUMBRA COIL 400. DURING THE PROCEDURE, THE COIL UNINTENTIONALLY DETACHED AND FLOATED INTO THE MEDIA. THE COIL WAS RETRIEVED USING A SEPARATOR AND NO FURTHER ISSUE WAS REPORTED OR ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349426 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F21979

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention