BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA COIL 400

    MDR report key: 2950399 · Received February 8, 2013

    Report

    Report Number
    3005168196-2013-00054
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K103305
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE COIL IS DAMAGED AND STRETCHED. THE PET LOCK AT THE PROXIMAL END OF THE PUSHER IS BROKEN AND THE PULL WIRE IS MISSING. THE COIL PROXIMAL CONSTRAINT BALL AND PULL WIRE ARE NOT IN THE DISTAL DETACHMENT TIP (DDT). THESE OBSERVATIONS ARE CONSISTENT WITH A NORMAL POST DEPLOYMENT CONDITION. THE HUB OF THE PX400 MICROCATHETER IS NO LONGER ATTACHED. THE COIL PUSHER ASSEMBLY IS INSIDE THE MICROCATHETER. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED AND CONFIRMED. THE COMPLAINT MENTIONED THAT DURING THE INSERTION OF THE COIL INTO THE PX400 MICROCATHETER, THERE WAS RESISTANCE FELT AND THE COIL WAS FOUND INSIDE THE HUB OF THE CATHETER FOLDED. AFTER NOTICING THIS, THE PHYSICIAN DECIDED TO CONTINUE THE PROCEDURE. IF THE COIL WAS DAMAGED WHEN THE RESISTANCE WAS FELT AND THE COIL FOLDED INSIDE THE HUB OF THE CATHETER, FURTHER USE OF THE DAMAGED COIL LIKELY CAUSED THE COIL TO BECOME DETACHED AND UNRAVELED AS DESCRIBED IN THE COMPLAINT. THE IFU FOR THE DEVICE STATES THAT DAMAGED DEVICES SHOULD NOT BE USED AND THAT ANY RESISTANCE SHOULD BE EVALUATED BEFORE CONTINUING THE PROCEDURE. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT WAS UNDERGOING TREATMENT FOR RIGHT MCA CEREBRAL ANEURYSM. THE FIRST COIL (16MMX60MM) WAS INTRODUCED INTO THE PATIENT'S BODY ALONG A MICRO CATHETER (PX400) UNDER BALOON ASSISTANCE. THE PHYSICIAN FELT RESISTANCE AND CAME NOT TO BE ABLE TO MOVE IT BACK AND FORTH, AND THEN THE COIL WAS CONFIRMED UNRAVELED. HE ATTEMPTED TO RETRIEVE THE COIL BY A GOOSE NECK SNARE BUT IT BROKE AND A PART OF THE COIL FAILED TO BE REMOVED AND REMAINED IN THE PATIENT'S BODY. THE REMINDER OF THE COIL WAS CONFIRMED AROUND THE MIDDLE OF ICA ON ANGIOGRAPHY. PHYSICIAN'S COMMENT WHEN ATTEMPTING TO INSERT THE COIL INTO THE PX400 MICRO CATHETER, RESISTANCE FELT AND THE COIL WAS FOUND IN THE HUB AND FOLDED BUT CONTINUED THE PROCEDURE. THIS COULD CAUSE THE UNRAVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53998 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F28871

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention