BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA CATHETER 025 (PX400 MICROCATHETER)

    MDR report key: 2383242 · Received December 20, 2011

    Report

    Report Number
    3005168196-2011-00433
    Event Type
    Malfunction
    Date Received
    December 20, 2011
    Date of Event
    November 21, 2011
    Report Date
    November 21, 2011
    Manufacturer
    PENUMBRA, INC
    Product Code
    DQY
    PMA / PMN Number
    K100826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN AND A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THE DEVICE MANUFACTURING RECORDS FOR THIS LOT HAVE BEEN REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN OR QUALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION:THERE WAS NO VISIBLE DAMAGE TO THE CATHETER. THE DISTAL MARKER AND 3 CM MARKER FOR FLUOROSCOPY WERE VISIBLE. A 0.025" MANDREL WAS INTRODUCED INTO THE HUB AND ADVANCED DISTALLY. THE MANDREL MOVED EASILY ALL THE WAY TO AND BEYOND THE DISTAL TIP. NO UNUSUAL FRICTION WAS ENCOUNTERED. THE CATHETER IS FULLY FUNCTIONAL. THE FRICTION ADVANCING THE COIL INSIDE THE CATHETER NOTED IN THE COMPLAINT COULD NOT BE CONFIRMED. NO COMMENTS WERE MADE REGARDING THE TORTUOSITY OF THE PATIENT'S VESSELS OF THE APPROACH TO THE TREATMENT SITE. VESSEL TORTUOSITY CAN HAVE AN IMPACT ON PERCEIVED FRICTION.

    Description of Event or Problem · 1

    THIS WAS A RUPTURED ANEURYSM CASE THAT WAS SEEN TO BE GOOD CANDIDATE FOR A PENUMBRA COIL 400 SYSTEM DUE TO THE LARGE SIZE 11.7MM X 11.7MM. A PENUMBRA PX40045 CATHETER WAS INSERTED VIA A SHUTTLE SHEATH INTO THE ANEURYSM AND THEN JAILED WITH A STENT. THE FIRST COIL CHOSEN BY THE PHYSICIAN WAS A 10X40 COMPLEX STANDARD. THE COIL WAS INSERTED WITHOUT REMARK. THE NEXT COIL INSERTED WAS A 7X20 COMPLEX STANDARD. THE PHYSICIAN SEEMED TO HAVE SOME DIFFICULTY INSERTING THIS COIL, ACTUALLY ATTEMPTING TO WITHDRAW COIL. SHE WAS UNSUCCESSFUL IN DOING SO SAYING THAT THE COIL FELT AS IF IT WAS STRETCHING. SHE WAS ABLE TO FINISH THE INSERTION OF THIS COIL. THE PHYSICIAN NEXT USED A 3X8 CURVE EXTRA SOFT COIL. AS THIS COIL WAS TRACKING THROUGH THE CATHETER WE COULD SEE THAT THE COIL WAS BUCKLING. THE PHYSICIAN SAID SHE WAS FEELING A GREAT DEAL OF RESISTENCE AND DIDN'T WANT TO PROCEED WITH THIS COIL. SHE THEN SWITCHED TO AN SL10 CATHETER AND FINISHED THE CASE WITHOUT ISSUE WITH 10 COILS. ONE OTHER THING OF NOTE WAS THAT THE PROXIMAL MARKER ON THE CATHETER WAS NOT VISIBLE DURING THE CASE. IT COULD HAVE BEEN BEHIND THE WIRE THAT THE STENT WAS DEPLOYED OVER, BUT WE WERE ABLE TO SEE THE PROXIMAL MARKER OF THE SL10 WITH THE IMAGING IN THE SAME POSITION. THERE WAS NO PATIENT INJURY RELATED TO THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA CATHETER 025 (PX400 MICROCATHETER) DQY DQY PENUMBRA, INC F19735

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR