BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDC-10 SOFT 3MM X 4CM

    MDR report key: 3853665 · Received June 6, 2014

    Report

    Report Number
    3008853977-2014-00175
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 10, 2014
    Report Date
    July 15, 2014
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    PMA / PMN Number
    K031049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION AVAILABLE, IT IS LIKELY THAT THE EXCESS FORCE EXERTED ON THE UNIT DURING PREPARATION RESULTED IN THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE COIL WAS STRETCHED AND HAD BROKEN OFF AT THE PROXIMAL END AS A RESULT OF BEING EXTENSIVELY STRETCHED. BASED ON THE INVESTIGATION AND INFORMATION AVAILABLE, IT IS LIKELY THAT THE EXCESS FORCE EXERTED ON THE UNIT DURING PREPARATION RESULTED IN THE REPORTED EVENT.

    Description of Event or Problem · 1

    DURING PREPARATION OF THE DEVICE, THE PHYSICIAN EXPERIENCED RESISTANCE WHEN ADVANCING THE COIL IN THE INTRODUCER SHEATH. THE PHYSICIAN EXAMINED THE COIL AND NOTED THAT IT WAS BROKEN INSIDE OF THE INTRODUCER SHEATH. THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 1

    DURING PREPARATION OF THE DEVICE, THE PHYSICIAN EXPERIENCED RESISTANCE WHEN ADVANCING THE COIL IN THE INTRODUCER SHEATH. THE PHYSICIAN EXAMINED THE COIL AND NOTED THAT IT WAS BROKEN INSIDE OF THE INTRODUCER SHEATH. THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 1

    DURING PREPARATION OF THE DEVICE, THE PHYSICIAN EXPERIENCED RESISTANCE WHEN ADVANCING THE COIL IN THE INTRODUCER SHEATH. THE PHYSICIAN EXAMINED THE COIL AND NOTED THAT IT WAS BROKEN INSIDE OF THE INTRODUCER SHEATH. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332961 GDC-10 SOFT 3MM X 4CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 17049682

    Patients

    Seq Age Sex Outcome Treatment
    1