BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET HELICAL ULTRA 4 MM X 8 CM

    MDR report key: 3192480 · Received June 27, 2013

    Report

    Report Number
    3008853977-2013-00208
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 16, 2013
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    PMA / PMN Number
    K093142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. DEVICE ANALYSIS REVEALED THAT THE MAIN COIL WAS NOT ATTACHED TO THE DELIVERY. IT IS EVIDENT THAT THE COIL HAD DETACHED FROM THE DETACHMENT ZONE AND NOT VIA ELECTROLYSIS. IN ADDITION THE PROXIMAL CONTACT WAS FOUND TO BE BENT. ADDITIONAL INFORMATION AVAILABLE INDICATED THAT THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION POST UNPACKING AND PREPARATION AND IT WAS PREPARED AS PER DIRECTIONS FOR USE (DFU). IT IS LIKELY THAT THE BENT PROXIMAL CONTACT OCCURRED DURING HANDLING AS THIS WAS NOT A REPORTED ISSUE BY THE USER. BASED ON THE INFORMATION AVAILABLE IT IS PROBABLE THAT PREMATURE DETACHMENT OF THE COIL OCCURRED DUE TO PROCEDURAL FACTORS LIMITING ITS PERFORMANCE. THEREFORE, A ROOT CAUSE OF OPERATIONAL CONTEXT HAS BEEN ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE COIL PREMATURELY DETACHED. THERE WERE NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE COIL PREMATURELY DETACHED. THERE WERE NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293471 TARGET HELICAL ULTRA 4 MM X 8 CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 15211549

    Patients

    Seq Age Sex Outcome Treatment
    1