BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POD COIL

    MDR report key: 7502158 · Received May 9, 2018

    Report

    Report Number
    MW5077102
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    March 14, 2018
    Report Date
    May 7, 2018
    Manufacturer
    PENUMBRA
    Product Code
    HCG
    UDI-DI
    M424RBYPOD40
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD RUPTURED CEREBRAL ANEURYSM REQUIRING COIL EMBOLIZATION FOR SACRIFICE OF PARENT VESSEL. SURGEON USED A COIL APPROVED BY FDA FOR THIS PURPOSE FURNISHED BY PENUMBRA, INC. DURING THE DEPLOYMENT OF THE COIL, THE LINK BETWEEN THE IMPLANTED PORTION AND THE DELIVERY SYSTEM BECAME PREMATURELY DETACHED IN AN UNINTENDED FASHION. THIS LED TO A SITUATION OF POSSIBLE STROKE, AS MANIFESTED BY LOSS IN PROCEDURAL EVOKED POTENTIALS, EVEN THOUGH THERE WAS NEVER ANY ANGIOGRAPHIC CONFIRMATION OF AN UNINTENDED VESSEL OCCLUSION THAT COULD ACCOUNT FOR IT. MALFUNCTIONING PRODUCT IS IN RESERVED FOR EVALUATION. IMPACT ON PT OUTCOME STILL UNCLEAR, AS HE HAS SUCH A POOR NEUROLOGICAL EXAM FROM HIS INITIAL ANEURYSM BLEED THAT DETECTING A NEW STROKE IS DIFFICULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342903 POD COIL DEVICE NEUROVASCULAR EMBOLIZATION HCG PENUMBRA RBYPOD4 F75631 M424RBYPOD40

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other