BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 2080167 · Received April 7, 2011

    Report

    Report Number
    3005168196-2011-00159
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K103305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE COIL AND PUSHER DISTAL ASSEMBLY WAS INTACT. EXAMINATION SHOWED THAT THE PULL WIRE WAS BROKEN INSIDE THE PULL TUBE AND WAS BENT PRIOR TO THE FRACTURE POINT. THE PULL TUBE WAS ALSO BENT ALONG THE SKIVED SEGMENT. THERE WAS EVIDENCE OF A TENSILE FAILURE AT THE BREAK SITE. TO CONFIRM THAT NO ADDITIONAL ABNORMALITIES EXISTED ALONG THE LENGTH OF THE PULL WIRE, THE PUSHER WAS THEN CUT AT THE POLYMER HYPOTUBE MIDJOINT AND THE HYPOTUBE WAS PULLED OFF THE PULL WIRE (LEAVING THE DISTAL POLYMER SHAFT AND THE FULL LENGTH OF PULL WIRE). NO FRICTION WAS NOTED WHEN THE HYPOTUBE WAS WITHDRAWN AND NO EVIDENCE OF FRACTURES, KINKS, OR OTHER DEFORMATIONS WERE NOTED ALONG THE LENGTH OF THE EXPOSED PROXIMAL PULL WIRE. NEXT, THE DISTAL SEGMENT OF PULL WIRE WAS PULLED FROM THE DISTAL SHAFT TO RELEASE THE COIL FROM THE DISTAL DETACHMENT TIP. THE PULL WIRE MOVED EASILY AND RELEASED THE PROXIMAL CONSTRAINT OF THE COIL AS EXPECTED. THIS SUGGESTS THAT THE PULL WIRE FRACTURE AT THE PULL TUBE WAS THE ONLY ABNORMALITY IN THE PUSHER ASSEMBLY STRUCTURE. CONCLUSION: THE FAILURE TO DETACH THIS COIL WAS CAUSED BY THE BREAK OF THE PULL WIRE AT THE PROXIMAL END OF THE PUSHER. THE CAUSE OF THIS BREAK HAS NOT BEEN IDENTIFIED BUT COULD BE RELATED TO THE PHYSICIAN'S MANIPULATION OF THE PROXIMAL END OF THE PUSHER ASSEMBLY WITH THE HANDLE DURING THE DETACHMENT PROCESS. SPECIFICALLY, THE COMPLAINT NOTED THAT THE PHYSICIAN REPEATEDLY BENT THE DETACHMENT HANDLE AFTER THE PUSHER WAS SEATED IN THE FUNNEL FEATURE, WHICH WOULD INDUCE A SIGNIFICANT AMOUNT OF FRICTION BETWEEN THE PULL WIRE AND THE PROXIMAL END OF THE PUSHER COULD LEAD TO A TENSILE FAILURE. 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 PHYSICIAN USED THE PENUMBRA COIL SYSTEM AS DESIGNED YET COULD NOT DETACH THE COIL AFTER TWO ATTEMPTS. HE THEN TRIED TO DETACH WITH HIS HANDS MULTIPLE TIMES AND WAS UNSUCCESSFUL. THE DETACHMENT HANDLE AND COIL WERE REMOVED WITHOUT INCIDENT, AND THE PHYSICIAN PLACED ANOTHER COIL SUCCESSFULLY. IT WAS NOTED THAT DURING THE CASE, THE PHYSICIAN HAD INTERMITTENT SUCCESS DETACHING COILS. THE PENUMBRA REPRESENTATIVE AT THE CASE REVIEWED THE PROPER TECHNIQUE FOR DETACHING COILS WITH THE PHYSICIAN BEFORE AND DURING THE CASE. THIS MDR IS ASSOCIATED WITH MDRS 3005168196-2011-00158 THROUGH 3005168196-2011-00162.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F18753

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR