BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 3222954 · Received July 12, 2013

    Report

    Report Number
    3005168196-2013-00278
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K103305
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE PUSHER ASSEMBLY STILL HAS THE PET-LOCK ON THE PROXIMAL END OF THE WIRE. THE PUSHER ASSEMBLY ALSO HAS THE CONSTRAINT BALL STILL ATTACHED INSIDE THE DISTAL DETACHMENT TIP (DDT). THESE OBSERVATIONS ARE CONSISTENT WITH AN UNDETACHED COIL HOWEVER, THE COIL IS NOT DETACHED. A SMALL SEGMENT OF THE COIL STRETCH RESISTANT WIRE CAN BE SEEN PROTRUDING FROM THE DDT. THE COIL SR WIRE IS BROKEN. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED AND CONFIRMED. THE COMPLAINT STATES THAT AFTER MULTIPLE ATTEMPTS TO REPOSITION THE COIL IT DETACHED UNINTENTIONALLY IN THE PATIENT. DURING THE EVALUATION OF THE PRODUCT IT WAS NOTICED THAT THE CONSTRAINT BALL WAS STILL INSIDE OF THE DDT AND THE COIL SR WIRE WAS BROKEN. IT IS LIKELY THAT WHEN REPOSITIONING THE COIL IN THE PATIENT, THE FORCE EXERTED ON THE COIL EXCEEDED THE TENSILE STRENGTH SPECIFICATION OF THE COIL SR WIRE MATERIAL, CAUSING THE WIRE TO BREAK 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

    PENUMBRA COIL 400 WAS BEING PLACED BY PHYSICIAN. AFTER MULTIPLE ATTEMPTS TO REPOSITION THE COIL AND THE CATHETER, THE COIL DETACHED, LEAVING A TAIL IN THE PARENT VESSEL OF THE PATIENT. THE PHYSICIAN TRIED REMOVING THE COIL WITH A SNARE, BUT WAS UNSUCCESSFUL. A STENT WAS USED TO TRAP THE COIL AND THE PROCEDURE WAS CONSIDERED SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321797 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F20457

    Patients

    Seq Age Sex Outcome Treatment
    1 51 Required Intervention