BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPAQ - PLATINUM MICROCOIL

    MDR report key: 4000192 · Received August 11, 2014

    Report

    Report Number
    1226348-2014-00171
    Event Type
    Malfunction
    Date Received
    August 11, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K080379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROCEDURE WAS FOR AN ACOM ANEURYSM. THE DELTAPAQ 1.5X4 MICRO COIL (DFS10015420/G13386) DID NOT DETACH AND THE CONNECTION LIGHT DID NOT LIGHT UPON DETACHMENT. THE COIL WAS ADVANCED WITHOUT COMPLICATION OR MANIPULATION. THE GREEN LIGHT ILLUMINATED DURING THE PRE-DEPLOYMENT ELECTRICAL CHECK. THE PHYSICIAN HAD PLACED AN ENTERPISE STENT, A MICRUSPHERE COIL AND A DETLAPAQ COIL (DETAILS ALL UNKNOWN) WITH OUT ANY ISSUES. THE PHYSICIAN SWITCHED OUT BOTH THE CABLE AND BATTERY (DETAILS UNKNOWN), AS WELL AS TRIED TO REPOSITION THE DELTAPAQ COIL SEVERAL TIMES WITHOUT SUCCESS. THE DELTAPAQ1.5X4 WAS REMOVED AND A NEW DELTAPAQ 1.5 X 4 (DETAILS UNKNOWN) WAS DEPLOYED WITHOUT COMPLAINT. AN SL-10 MICROCATHETER (STRYKER DETAILS UNKNOWN) WAS USED. THE DEVICE POSITIONING UNIT (DPU) FAILED ELECTRICAL TESTING. THE DETACHMENT FIBER DID NOT RECEIVE HEAT AND MELT. THE MOST LIKELY CONTRIBUTING FACTOR TO THE MICROCOIL SYSTEM PASSING THE PRE-DEPLOYMENT ELECTRICAL CHECK AND FAILING TO DETACH INSIDE THE ANEURYSM MAY HAVE BEEN DUE TO A FRACTURE OF THE SOLDER CONNECTION JOINT LOCATED INSIDE THE RESISTIVE HEATING COIL. THE CIRCUMSTANCES OF HOW AND WHERE THIS DAMAGE OCCURRED CANNOT BE DETERMINED AS ALL MICROCOIL SYSTEMS ARE ELECTRICALLY TESTED PRIOR TO FINAL PACKAGING. IN ADDITION, WITHOUT THE RETURN OF BOTH THE UNIDENTIFIED DETACHMENT CONTROL BOX (DCB) AND THE CONNECTING CABLE ALONG WITH THE SL-10 MICROCATHETER USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS HAD ANY ADDITIONAL CONTRIBUTIONS TO THE COMPLAINT EVENT. BASED ON THE INFORMATION AND THE ANALYSIS, THE EVENT COULD NOT BE CONFIRMED. A REVIEW OF THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS AN INITIAL/FINAL REPORT. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ENTERPISE STENT, A MICRUSPHERE COIL AND A DETLAPAQ COIL (DETAILS ALL UNKNOWN); NEW DELTAPAQ 1.5 X 4 (DETAILS UNKNOWN); CABLE AND BATTERY (DETAILS UNKNOWN); SL-10 MICROCATHETER (STRYKER DETAILS UNKNOWN).

    Description of Event or Problem · 1

    THE PROCEDURE WAS FOR AN ACOM ANEURYSM. THE DELTAPAQ 1.5X4 MICRO COIL (DFS10015420/ G13386) DID NOT DETACH AND THE CONNECTION LIGHT DID NOT LIGHT UPON DETACHMENT. THE GREEN LIGHT ILLUMINATED DURING THE PRE-DEPLOYMENT ELECTRICAL CHECK. THE PHYSICIAN HAD PLACED AN ENTERPISE STENT, A MICRUSPHERE COIL AND A DETLAPAQ COIL (DETAILS ALL UNKNOWN) WITH OUT ANY ISSUES. THE PHYSICIAN SWITCHED OUT BOTH THE CABLE AND BATTERY (DETAILS UNKNOWN), AS WELL AS TRIED TO REPOSITION THE DELTAPAQ COIL SEVERAL TIMES WITHOUT SUCCESS. THE DELTAPAQ1.5X4 WAS REMOVED AND A NEW DELTAPAQ 1.5 X 4 (DETAILS UNKNOWN) WAS DEPLOYED WITHOUT COMPLAINT. AN SL-10 MICROCATHETER (STRYKER DETAILS UNKNOWN) WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474848 DELTAPAQ - PLATINUM MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G13386

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR