BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    MDR report key: 2013712 · Received February 4, 2011

    Report

    Report Number
    3005168196-2011-00034
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    June 26, 2008
    Report Date
    June 26, 2008
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVALUATION: TWO REPERFUSION 032 CATHETERS AND ONE SEPARATOR 032 WERE RETURNED. THE FIRST REPERFUSION CATHETER WAS KINKED 2CM FROM THE TIP AND 1CM FROM THE HYPOTUBE. THE SECOND 032 CATHETER WAS KINKED 8CM FROM THE TIP. THE SEPARATOR WAS FOUND TO HAVE BOTH KINKS AND A FRACTURE JUST DISTAL FROM THE PROXIMAL SUPPORT TAPER. CONCLUSION: FRICTION WAS DUE TO KINKS IN THE DISTAL END OF THE CATHETERS. 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 FELT A LOT OF FRICTION WHILE MOVING AN 032 SEPARATOR THROUGH A 032 CATHETER. THE SEPARATOR THEN BROKE AT THE PROXIMAL TRANSITION SECTION OUTSIDE OF THE PATIENT. THE PHYSICIAN SWITCHED TO A SECOND 032 SYSTEM. THE SECOND 032 CATHETER TRACKED TO THE SITE WITHOUT ISSUE BUT THE PHYSICIAN AGAIN EXPERIENCED A LOT OF FRICTION WHEN HE TRIED TO PLACE THE SEPARATOR. THE SECOND 032 SYSTEM WAS REPORTED AS HAVING STUCK IN THE CAVERNOUS CAROTID SEGMENT. PHYSICIAN THEN FINISHED THE PROCEDURE SUCCESSFULLY AFTER USING A 041 SYSTEM AND A 026 SYSTEM. THE PHYSICIAN NOTED THAT THERE WAS NO PATIENT INJURY AS A RESULT OF THIS INCIDENT. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2010-00175 AND MDR 3005168196-2011-00033. MDR 3005168196-2010-175 PERTAINS TO THE 032 SEPARATOR ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM REPERFUSION CATHETER 032 PERCUTANEOUS CATHETER NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1