BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKING COIL LP

    MDR report key: 12491902 · Received September 17, 2021

    Report

    Report Number
    3005168196-2021-02076
    Event Type
    Malfunction
    Date Received
    September 17, 2021
    Date of Event
    August 23, 2021
    Report Date
    March 26, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00815948021914
    PMA / PMN Number
    K192955
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND IS BEING CORRECTED ON THIS FOLLOW-UP #01 MFR REPORT: 3005168196-2021-02076. 1. SECTION H. BOX 6. DEVICE CODE 1. H3 OTHER TEXT: PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PACKING COIL LPS AND A LP SYSTEM DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, A PACKING COIL LP WOULD NOT DETACH WITH THE HANDLE AFTER MULTIPLE ATTEMPTS. THEREFORE, THE PACKING COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PACKING COIL LP AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1388457 PACKING COIL LP HCG, KRD HCG PENUMBRA, INC. RBYPCLP10 F99209 00815948021914

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown