BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPAQ - PLATINUM MICROCOIL

    MDR report key: 2853752 · Received December 3, 2012

    Report

    Report Number
    2954740-2012-00804
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 20, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K080379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE 5 MM X 15 CM DELTAPAQ PLATINUM MICROCOIL COULD NOT BE DETACHED. THE COIL WAS WITHDRAWN FROM THE SL-10 MICROCATHETER WITHOUT STRETCHING OR DETACHMENT. THERE WAS NO PATIENT INJURY. THE BOX AND CABLE WERE CHANGED. ALL OTHER COILS WERE FUNCTIONAL. THE PRE-DEPLOYMENT TEST WAS PERFORMED AND THE FAULT LIGHT WAS NOT SEEN DURING USE OF THE DCB AND CONNECTING CABLE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE DETACHMENT BUTTON WAS PRESSED 3 TIMES. THE RETURNED DEVICE POSITIONING UNIT (DPU) FAILED ELECTRICAL TESTING. THE DETACHMENT FIBER DID NOT RECEIVE HEAT AND MELT. THE DPU WAS FOUND TO HAVE BEEN SEVERELY KINKED; HOWEVER NO DAMAGED ELECTRICAL WIRING WAS FOUND AT THESE SECTIONS OR ON THE REMAINING EXTERNAL LOCATIONS OF THE DPU. THE ELECTRICAL CONNECTOR WAS DISSECTED AND FOUND TO BE FULLY CONNECTED AND SOLDERED. BECAUSE THE MICROCOIL SYSTEM PASSED A PRE-DEPLOYMENT ELECTRICAL INSPECTION, THE MOST LIKELY CONTRIBUTING FACTOR TO THE COILS FAILURE TO DETACH WAS DUE TO INTERNAL WIRING DAMAGE AT THE DISTAL SECTION WITH THE SOLDER JOINT CONNECTION FRACTURE AS THE MOST LIKELY ROOT CAUSE. THE CIRCUMSTANCES OF HOW AND WHERE THIS DAMAGE OCCURRED CANNOT BE DETERMINED. IN ADDITION, WITHOUT THE RETURN OF THE COMPLETE DETACHMENT SYSTEM, IT CANNOT BE DETERMINED IF THESE COMPONENTS HAD ANY OTHER ADDITIONAL CONTRIBUTIONS TO THE COMPLAINT EVENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. BASED ON THE AVAILABLE PROCEDURAL INFORMATION A DEFINITIVE CONCLUSION CANNOT BE MADE REGARDING ROOT CAUSE OF THE DAMAGE TO THE RETURNED DEVICE WHICH LIKELY CAUSED THE FAILURE TO DETACH. HOWEVER, BASED ON THE REPORT THAT THE PRE-DEPLOYMENT TEST WAS PERFORMED IT APPEARS THAT THE DAMAGE TO THE DEVICE OCCURRED DURING PROCEDURAL USE. ALTHOUGH ROOT CAUSE CANNOT BE DETERMINED, THERE IS NO INDICATION OF A RELATIONSHIP TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    PER RECEIVED REPORT, THE CUSTOMER COMPLAINED THAT IT WAS IMPOSSIBLE TO DETACH THE COIL. THEY CHANGED THE BOX AND THE CABLE. ALL OTHER COILS WERE FUNCTIONAL. THE MICROCATHETER USED WAS SL-10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTAPAQ - PLATINUM MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G13077

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SL-10 MICROCATHETER