BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL DETACHMENT HANDLE

    MDR report key: 5447943 · Received February 19, 2016

    Report

    Report Number
    3005168196-2016-00195
    Event Type
    Malfunction
    Date Received
    February 19, 2016
    Date of Event
    January 19, 2016
    Report Date
    January 20, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548011974
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTIONS WERE INADVERTENTLY MISSED ON THE INITIAL MFR REPORT AND ARE BEING INCLUDED ON THIS FOLLOW-UP #02 MFR REPORT:3005168196-2016-00195. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. IT WAS NOTED THAT THE DEVICE WAS USED PAST ITS EXPIRATION DATE. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 1. 3005168196-2016-00193, 2. 3005168196-2016-00194, 3. 3005168196-2016-00196, 4. 3005168196-2016-00197, 5. 3005168196-2016-00198.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 3005168196-2016-00193, 3005168196-2016-00194, 3005168196-2016-00196, 3005168196-2016-00197, 3005168196-2016-00198.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE A2 SEGMENT OF THE CEREBRAL ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS), A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND PENUMBRA COIL DETACHMENT HANDLES (HANDLE). DURING THE PROCEDURE, WHILE ADVANCING A PC400 COIL (LOT # F63825) THROUGH THE PX SLIM, THE PHYSICIAN MET RESISTANCE AND DECIDED TO REMOVE BOTH THE PX SLIM AND THE PC400 COIL. AFTER REMOVING BOTH DEVICES FROM THE PATIENT, THE PHYSICIAN NOTICED THAT THE PC400 COIL WAS DAMAGED AND HAD UNINTENTIONALLY DETACHED FROM THE PUSHER ASSEMBLY. A NEW PC400 COIL (LOT # F63825) WAS THEN DEPLOYED INTO THE ANEURYSM USING A NEW PX SLIM WITHOUT ANY ISSUES; HOWEVER, THE PHYSICIAN HAD DIFFICULTY DETACHING THE PC400 COIL IN THE ANEURYSM USING THE HANDLE (LOT # F31442). AFTER THREE UNSUCCESSFUL ATTEMPTS TO DETACH THE PC400 COIL USING THE HANDLE, THE PHYSICIAN ATTEMPTED TO USE A NEW HANDLE (LOT # F31442) BUT WAS STILL UNSUCCESSFUL. THE PC400 COIL WAS THEN DETACHED MANUALLY BY THE PHYSICIAN. ANOTHER PC400 COIL (LOT # F36541) WAS THEN DEPLOYED INTO THE ANEURYSM; HOWEVER, THE PHYSICIAN WAS UNABLE TO DETACH THE COIL USING THE HANDLE AND DECIDED TO MANUALLY DETACH THE COIL. THE PROCEDURE WAS COMPLETED AT THIS POINT SINCE THE PHYSICIAN CONSIDERED THE ANEURYSM TO HAVE BEEN PROPERLY FILLED WITH THE TWO PC400 COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104841 PENUMBRA COIL DETACHMENT HANDLE HCG, KRD HCG PENUMBRA, INC. F31442 00814548011974

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR