BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTAPAQ - CERECYTE MICROCOIL

    MDR report key: 5642365 · Received May 9, 2016

    Report

    Report Number
    1226348-2016-00084
    Event Type
    Injury
    Date Received
    May 9, 2016
    Date of Event
    April 28, 2016
    Report Date
    May 4, 2016
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    PMA / PMN Number
    K080437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY THE HOSPITAL CONTACT THAT THE DELTAPAQ 3X10 (CDF10031030/C34067) COULD NOT BE RELEASED USING THE CABLE (CCB00015700/P11121) AND DCB (DCB00000500/F63222). AN ACOM ANEURYSM WAS SOUNDED BY MEANS OF A MICRO-CATHETER SL-10 (DETAILS UNKNOWN). ANEURYSM WAS TREATED WITH AN ATLAS STENT FROM STRYKER (DETAILS UNKNOWN). PRESIDIO 4X11.5 (C32673) WAS USED AS A FRAMING COIL. THE NEXT COIL USED WAS DELTAPAQ 3X10 (C34067) WHICH HOWEVER COULD NOT BE RELEASED. THE MICRO-CATHETER WAS MOVED SEVERAL TIMES TO ACHIEVE A GOOD CONTACT AND THE RELEASE CABLE WAS REPLACED AS WELL. DESPITE ALL THAT IT WAS NOT POSSIBLE TO DETACH THE COIL. THE PHYSICIAN TRIED TO REMOVE THE COIL BY PUSHING THE SL 10. WHEN ONLY A QUARTER OF THE COIL WAS STILL LOCATED IN THE ANEURYSM THE COIL TORE OFF FROM THE PUSH-WIRE. THE PHYSICIAN WAS ABLE TO PUSH THE COIL BACK INTO THE ANEURYSM. FOLLOWED THAT FIVE ADDITIONAL COILS (DETAILS UNKNOWN) WERE PLACED IN THE ANEURYSM OF WHICH THERE OF THEM NEEDED MULTIPLE DETACHMENT ACTIVITIES. THE DETACHMENT BOX INVOLVED WAS USED FOR APPROX. 150 INTERVENTIONS. IT WAS INITIALLY REPORTED THAT ONLY THE CABLE AND BOX WILL BE RETURNED FOR ANALYSIS. THE DELTAPAQ WILL NOT BE RETURNED, THEREFORE THE ROOT CAUSE OF THE COIL UNABLE TO BE DETACHED CANNOT BE DETERMINED. HOWEVER PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO 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. THIS IS AN INITIAL/FINAL REPORT. (B)(4). CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: DCB (DCB00000500/F63222); CABLE (CCB00015700/P11121); MICRO-CATHETER SL-10 (DETAILS UNKNOWN); ATLAS STENT FROM STRYKER (DETAILS UNKNOWN); PRESIDIO 4X11.5 (C32673); NEW CABLE (DETAILS UNKNOWN); FIVE ADDITIONAL COILS (DETAILS UNKNOWN).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITAL CONTACT THAT THE DELTAPAQ 3X10 (CDF10031030/C34067) COULD NOT BE RELEASED USING THE CABLE (CCB00015700/P11121) AND DCB (DCB00000500/F63222). AN ACOM ANEURYSM WAS SOUNDED BY MEANS OF A MICRO-CATHETER SL-10 (DETAILS UNKNOWN). ANEURYSM WAS TREATED WITH AN ATLAS STENT FROM STRYKER (DETAILS UNKNOWN). PRESIDIO 4X11.5 (C32673) WAS USED AS A FRAMING COIL. THE NEXT COIL USED WAS DELTAPAQ 3X10 (C34067) WHICH HOWEVER COULD NOT BE RELEASED. THE MICRO-CATHETER WAS MOVED SEVERAL TIMES TO ACHIEVE A GOOD CONTACT AND THE RELEASE CABLE WAS REPLACED AS WELL. DESPITE ALL THAT IT WAS NOT POSSIBLE TO DETACH THE COIL. THE PHYSICIAN TRIED TO REMOVE THE COIL BY PUSHING THE SL 10. WHEN ONLY A QUARTER OF THE COIL WAS STILL LOCATED IN THE ANEURYSM THE COIL TORE OFF FROM THE PUSH-WIRE. THE PHYSICIAN WAS ABLE TO PUSH THE COIL BACK INTO THE ANEURYSM. FOLLOWED THAT FIVE ADDITIONAL COILS (DETAILS UNKNOWN) WERE PLACED IN THE ANEURYSM OF WHICH THERE OF THEM NEEDED MULTIPLE DETACHMENT ACTIVITIES. THE DETACHMENT BOX INVOLVED WAS USED FOR APPROX. 150 INTERVENTIONS. IT WAS INITIALLY REPORTED THAT ONLY THE CABLE AND BOX WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296633 DELTAPAQ - CERECYTE MICROCOIL CNV DCS COILS HCG MEDOS INTERNATIONAL SARL C34067

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR