BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIX STRETCH RESISTANT (SR) COILS

    MDR report key: 1760332 · Received July 16, 2010

    Report

    Report Number
    2939204-2010-00817
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    May 26, 2010
    Report Date
    July 7, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K050700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. INSPECTION OF THE RETURNED DEVICE FOUND THAT THE COIL WAS BROKEN FROM THE PUSHER WIRE. THE COIL WAS ALSO NOTED TO BE STRETCHED IN THE REGION WHERE THE COIL BROKE. IT APPEARED THAT THE COIL BECAME EXTENSIVELY STRETCHED THEN BROKE. THE INTERNAL AND EXTERNAL SUTURE ALSO BROKE AS A RESULT OF THE EXTENSIVE STRETCHING. THE DISTAL END OF THE COIL WAS KINKED, THIS MOST LIKELY OCCURED AS THE COIL WAS ADVANCED INTO THE CATHETER HUB. NO OTHER ANOMALIES WERE NOTED. BASED ON THE INVESTIGATION AND THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE OF THE BROKEN COIL IS HANDLING BY THE PHYSICIAN DURING INTRODUCTION TO THE MICROCATHETER.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE COIL WAS BROKEN. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX STRETCH RESISTANT (SR) COILS DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK M003471408SR0 12323003

    Patients

    Seq Age Sex Outcome Treatment
    1