BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASHMERE 14 - PLATINUM MICROCOIL

    MDR report key: 3166110 · Received June 12, 2013

    Report

    Report Number
    1226348-2013-20111
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 22, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K022420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE PRODUCT WILL BE RETURNED FOR ANALYSIS, HOWEVER IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: SL-10 MICROCATHETER (DETAILS UNKNOWN); 2 DETACHMENT CONTROL BOX (DETAILS UNKNOWN); CONNECTING CABLE (DETAILS UNKNOWN).

    Additional Manufacturer Narrative · 1

    THE CASHMERE 14 PLATINUM MICROCOIL 12 MM X 30 CM (SRC14123020/G11225) WOULD NOT DETACH ONCE FULLY DEPLOYED WITH THE FIRST DETACHMENT BOX (DCB000005-00/F41701). THE CUSTOMER TRIED ANOTHER DETACHMENT BOX (DCB000001-20/B0868) AND IT DID NOT DEPLOY. THEY DID NOT TRY A NEW DETACHMENT CORD. THE DETACHMENT CORD WAS USED TO DETACH OTHER COILS USED IN THE PROCEDURE. AN SL-10 MICROCATHETER (DETAILS UNKNOWN) WAS USED. A NEW COIL AND THE FIRST DETACHMENT BOX WERE USED TO COMPLETE THE PROCEDURE. THE SECOND DETACHMENT BOX WAS ONLY USED TO RE-TRY TO DETACH THE PROBLEM COIL. THERE WERE NO DAMAGES NOTED ON THE COIL PRIOR TO AND AFTER USE. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE LOW BATTERY LIGHT AND FAULT LIGHT WERE NOT SEEN DURING THE CASE. THE GREEN SYSTEM READY LIGHT ILLUMINATED. IT IS UNKNOWN IF THE DETACHMENT LIGHT ILLUMINATED DURING THE DETACHMENT CYCLE OR IF THE AUDIBLE SOUND BEEPED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. PATIENT DEATH OR SERIOUS INJURY DID NOT OCCUR AS A RESULT OF THE EVENT. ADDITIONAL MEDICAL INTERVENTION OR MEDICATION WAS NOT REQUIRED TO PREVENT IMPAIRMENT OR INJURY. (B)(4). THE SECOND DETACHMENT CONTROL BOX ((DCB000001-20/B0868) THAT WAS NOT USED IN ATTEMPT TO DETACH COILS FOLLOWING THE EVENT WAS NOT RETURNED FOR ANALYSIS. WITHOUT THE RETURN OF THE DEVICE NO DEFINITIVE CONCLUSION REGARDING THE RELATIONSHIP OF THIS DEVICE TO THE REPORTED EVENT CAN BE DETERMINED. 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. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. (B)(4). THE DEVICE WAS RETURNED WITH THE COIL ATTACHED AND WITHOUT DAMAGE TO THE COIL. THE DEVICE POSITIONING UNIT (DPU) FAILED ELECTRICAL TESTING. THE DETACHMENT FIBER DID NOT RECEIVE HEAT. LABORATORY TESTING DUPLICATED THE FIELD COMPLAINT. THE MOST LIKELY CONTRIBUTING FACTOR TO THE MICROCOIL SYSTEM PASSING THE ELECTRICAL PRE-DEPLOYMENT CHECK, BUT FAILING TO DETACH INSIDE THE ANEURYSM APPEARS TO BE DUE TO A FRACTURE TO THE SOLDER JOINT CONNECTION INSIDE THE RESISTIVE HEATING COIL SECTION. THE CIRCUMSTANCES OF HOW AND WHERE THIS DAMAGE OCCURRED CANNOT BE DETERMINED. IN ADDITION, WITHOUT THE RETURN OF THE COMPLETE DETACHMENT SYSTEM AND THE SL-10 MICROCATHETER USED IN THE PROCEDURE, IT CANNOT BE DETERMINE IF THESE COMPONENTS CONTRIBUTED TO THE COMPLAINT EVENT. HOWEVER THE CABLE AND MICROCATHETER WERE USED WITH SUBSEQUENT COILS WITHOUT ANY INDICATION CONTRIBUTING TO THE EVENT. ALL MICROCOIL SYSTEMS ARE ELECTRICAL INSPECTED MULTIPLE TIMES PRIOR TO FINAL PACKAGING. ADDITIONALLY, AS NOTED THE PRE-DEPLOYMENT CHECK WAS PERFORMED BY THE USER. BASED ON THIS IT APPEARS THAT THE DAMAGE TO THE SYSTEM MAY HAVE OCCURRED DURING PROCEDURAL USE OR POST PROCEDURAL USE. WITH REVIEW OF THE REPORTED INFORMATION NO CONCLUSION CAN BE MADE REGARDING POSSIBLE FACTORS CONTRIBUTING TO THE DAMAGE TO THE SYSTEM WHICH APPEARS TO HAVE CAUSED THE 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. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE CASHMERE 14 PLATINUM MICROCOIL 12 MM X 30 CM (SRC14123020/G11225) WOULD NOT DETACH ONCE FULLY DEPLOYED. THE CUSTOMER TRIED ANOTHER DETACHMENT BOX (DETAILS UNKNOWN) AND IT DID NOT DEPLOY. THEY DID NOT TRY A NEW DETACHMENT CORD. THE DETACHMENT CORD WAS USED TO DETACH OTHER COILS USED IN THE PROCEDURE. AN SL-10 MICROCATHETER (DETAILS UNKNOWN) WAS USED. A NEW COIL AND THE FIRST DETACHMENT BOX WERE USED TO COMPLETE THE PROCEDURE. THE SECOND DETACHMENT BOX WAS ONLY USED TO RE-TRY TO DETACH THE PROBLEM COIL. THERE WERE NO DAMAGES NOTED ON THE COIL PRIOR TO AND AFTER USE. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE LOW BATTERY LIGHT AND FAULT LIGHT WERE NOT SEEN DURING THE CASE. THE GREEN SYSTEM READY LIGHT ILLUMINATED. IT IS UNKNOWN IF THE DETACHMENT LIGHT ILLUMINATED DURING THE DETACHMENT CYCLE OR IF THE AUDIBLE SOUND BEEPED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. PATIENT DEATH OR SERIOUS INJURY DID NOT OCCUR AS A RESULT OF THE EVENT. ADDITIONAL MEDICAL INTERVENTION OR MEDICATION WAS NOT REQUIRED TO PREVENT IMPAIRMENT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265227 CASHMERE 14 - PLATINUM MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G11225

    Patients

    Seq Age Sex Outcome Treatment
    1