BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE HELIX STANDARD DETACHABLE COIL

    MDR report key: 5145148 · Received March 25, 2004

    Report

    Report Number
    2029214-2004-00049
    Event Type
    Malfunction
    Date Received
    March 25, 2004
    Date of Event
    February 23, 2004
    Report Date
    March 25, 2004
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED COIL WAS EVALUATED VISUALLY AND FUNCTIONALLY, WHERE POSSIBLE. THE PROXIMAL END OF THE DETACHMENT ZONE WAS COMPLETE AND ATTACHED TO THE GUIDEWIRE. THE DISTAL END OF THE DETACHMENT ZONE APPEARED DARKER THAN THE PROXIMAL END. THE DETACHMENT WIRE LENGTH WAS MEASURED AS LONGER THAN THE UPPER SPECIFICATION LIMIT FOR THIS MODEL. THE COIL SHELL TO DETACH WIRE WELD APPEARS TO HAVE FAILED, CAUSING THE UNEXPECTED COIL DETACHMENT. A NON-DESTRUCTIVE 100% IN-PROCESS TENSILE STRENGTH INSPECTION IS PERFORMED ON EVERY MANUFACTURED LOT TO VERIFY WELD STRENGTH. THIS IS BEING CONSIDERED AN ISOLATE EVENT.

    Description of Event or Problem · 1

    DURING PLACEMENT OF FIRST COIL, DOCTOR NOTED A SIGNIFICANT SPACE AT THE PROXIMAL MARKER OF THE CATHETER. THE COIL WAS PULLED BACK AND A PREMATURE SEPARATION OF THE DETACHABLE COIL WAS CONFIRMED. THE REMNANT OF THE COIL WAS PUSHED INTO THE ANEURYSM WITHOUT EVENT. THE COILING CONTINUED WITHOUT FURTHER EVENT, NO ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAPPHIRE HELIX STANDARD DETACHABLE COIL DETACHABLE COIL HCG MICRO THERAPEUTICS, INC. E-7-30-T10 77871

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention