BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET COIL

    MDR report key: 2173864 · Received July 24, 2011

    Report

    Report Number
    2939204-2011-00382
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K093142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FROM THE USER FACILITY STATED THAT MODERATE FRICTION WAS NOTED AS THE COIL WAS ADVANCED IN THE INTRODUCER SHEATH TOWARDS THE MICROCATHETER. THE PHYSICIAN APPLIED "MODERATE" FORCE TO OVERCOME THE RESISTANCE TO ADVANCE THE COIL.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. VISUAL AND MICROSCOPIC INSPECTION OF THE RETURNED COIL FOUND THAT THE MAIN COIL WAS STILL ATTACHED TO THE DISTAL END OF THE DELIVERY WIRE. NO ANOMALIES WERE NOTED TO THE MAIN COIL. THERE WERE NO ANOMALIES NOTED AT THE MAIN JUNCTION OR THE FORM TIP. THERE WAS NO EVIDENCE OF THE COIL BREAKAGE. THE PROXIMAL CONTACT WAS FOUND TO BE BROKE OFF THE PROXIMAL END OF THE DELIVERY WIRE. EPOXY RESIDUE WAS EVIDENT ON THE PROXIMAL END OF THE PROXIMAL CONTACT INDICATING THAT THE PROXIMAL CONTACT WAS ATTACHED DURING THE MANUFACTURING PROCESS. MODERATE INTRODUCER FRICTION WAS NOTED AS THE COIL WAS ADVANCED IN THE INTRODUCER SHEATH. IT IS LIKELY THAT THE PROXIMAL CONTACT BROKE AS A RESULT OF FORCE BEING APPLIED TO ADVANCE THE COIL INTO THE MICROCATHETER AND THIS IS CONSIDERED HANDLING DAMAGE. ANALYSIS OF THE RETURNED DEVICE DID NOT FIND ANY EVIDENCE THAT THE COIL HAD BROKEN. THE PROXIMAL CONTACT IS A SUBCOMPONENT OF THE DEVICE LOCATED AT THE PROXIMAL END OF THE PUSHER WIRE AND REMAINS OUTSIDE THE PATIENT AT ALL TIMES DURING THE PROCEDURE; THERE IS NO CONTACT WITH THE PATIENT. MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENT OF A REPORTABLE EVENT FOR THE DEVICE IN QUESTION.

    Description of Event or Problem · 1

    DURING INTRODUCTION OF THE COIL IN THE MICROCATHETER, THE COIL BROKE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    DURING INTRODUCTION OF THE COIL IN THE MICROCATHETER, THE COIL BROKE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET COIL DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK M0035423080 0014062043

    Patients

    Seq Age Sex Outcome Treatment
    1