BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 3090590 · Received May 2, 2013

    Report

    Report Number
    3005168196-2013-00158
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 2, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K103305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE COIL IS STRETCHED OUT OF ITS NORMAL SPECIFICATION. ADDITIONALLY, THE PROXIMAL CONSTRAINT BALL IS MISSING FROM THE COIL. A NOTE WAS RETURNED WITH THE PRODUCT THAT STATED "DETACHED INSIDE CATHETER (B)(6) 2013." CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED AND CONFIRMED. THE COMPLAINT STATES THAT FRICTION WAS FELT WHEN ADVANCING THE COIL INTO THE CATHETER. DURING THE EVALUATION IT WAS NOTED THAT THE CONSTRAINT BALL WAS MISSING FROM THE COIL, INDICATING THAT EXCESSIVE FORCE WAS APPLIED TO THE COIL. THIS FORCE WAS GREATER THAN THE TENSILE STRENGTH SPECIFICATION OF THE MATERIAL, AND CAUSED THE CONSTRAINT BALL TO DETACH FROM THE SR-WIRE. SINCE THE COIL WAS THE ONLY PRODUCT RETURNED, THE CAUSE OF THIS FRICTION COULD NOT BE DIRECTLY DETERMINED. 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

    PATIENT WAS UNDERGOING COIL EMBOLIZATION TREATMENT FOR RIGHT ACA-ACOM ANEURYSM. THE ANEURYSM WAS ACCESSED WHERE FOUR COILS WERE PLACED TO ACHIEVE COMPLETE OBLITERATION OF THE ANEURYSM SACK. DURING THE PROCEDURE, THE FIRST COIL (COMPLEX SOFT 6X10) WAS LOADED INTO THE CATHETER AND THE FRICTION WAS NOTICED WHICH PREVENTED IT FROM BEING ADVANCED ALL THE WAY. WHILE RETRIEVING IT, THE COIL DETACHED PREMATURELY WITHIN THE MICROCATHETER. THE DEVICE MALFUNCTION IS NOT ASSOCIATED WITH ANY ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192292 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F31096

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR