BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA COIL 400

    MDR report key: 2912336 · Received January 11, 2013

    Report

    Report Number
    3005168196-2013-00027
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K103305
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: RESULTS: THE COIL IS DETACHED FROM THE PUSHER. THE COIL HAS VISUAL DAMAGE: THE COIL IS STRETCHED AND IS BROKEN INTO SEVERAL PIECES THAT ARE TANGLED. THIS IS CONSISTENT WITH THE COMPLAINT REPORT DESCRIPTION REGARDING USE OF A SNARE FOR COIL REMOVAL. THE PUSHER STILL HAS BLACK PET LOCK PROXIMAL END OF THE DEVICE. THIS IS CONSISTENT W THE DISTAL END OF THE PUSHER HAS THE DISTAL DETACHMENT TIP IN PLACE; HOWEVER THE CONSTRAINT BALL IS NOT INSIDE THE DISTAL DETACHMENT TIP (DDT). THE PUSHER PRECOMPRESSION WAS CONFIRMED. IN ADDITION, THE PUSHER DDT ID,AND PULL WIRE OD WERE MEASURED AND VERIFIED TO BE WITHIN SPECIFICATION. THE PROXIMAL BALL WAS NOT RETURNED FOR ANALYSIS. CONCLUSION: THE ISSUE NOTED IN THE COMPLAINT IS CONFIRMED. THE COIL WAS RETURNED AND IT LOOKS TO BE DAMAGED. THE UNIT APPEARS TO MEET ALL SPECIFICATIONS RELATED TO DETACHMENT; THEREFORE THE MOST LIKELY CAUSE OF DETACHMENT IS EXCEEDING THE TENSILE SPECIFICATION OF THE COIL. 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

    DISLOCATION OF VOL COIL DURING TREATMENT OF GIANT ANEURYSM. IN A PLANNED TREATMENT OF A GIANT ANEURYSM, THE PHYSICIAN DECIDED TO USE A RIBAR27 TO PLACE A NEUROFORM STENT AT THE NECK OF BASILAR ANEURYSM BEFORE BRINGING IN THE COIL , USING THE SAME RIBAR27. THE PENUMBRA REPRESENTATIVE GAVE THE RECOMMENDATION THAT IN COMBINATION WITH THE PENUMBRA COIL, THE PX400 WOULD BE THE MICROCATHETER WE RECOMMEND. THE NEUROFORM WAS PLACED , PENUMBRA COIL 400 ((B)(4)) WAS BROUGHT INTO THE ANEURYSM THROUGH THE RIBAR27. THE COIL WAS NOT DEPLOYED IN THE FULL LENGTH AND THE PHYSICIAN DECIDED NOT TO DETACH THE COIL BECAUSE OF NOT GETTING IT IN THE RIGHT POSITION. BY TRYING TO GET THE COIL BACK THROUGH RIBAR27 MICROCATHETER IT KINKED. HE TRIED PULL BACK THE RIBAR27 MICROCATHETER WITH THE COIL THROUGH THE NEUROFORM STENT HOWEVER, THE STENT MOVED AND DISLOCATED THE COIL. THE PHYSICIAN ATTEMPTED TO RETRIEVE SOME PARTS OF THE STRETCHED COIL WITH A SNARE. HOWEVER, SMALL PARTS OF THE COIL REMAINED. THERE WAS AN OCCLUSION OF THE VERTEBRAL ARTERY POST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19053 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F21616

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention