BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPAQ - PLATINUM MICROCOIL

    MDR report key: 3030408 · Received April 2, 2013

    Report

    Report Number
    1226348-2013-20062
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 9, 2013
    Report Date
    March 9, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K080379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: IT WAS REPORTED THAT THE 7 MM X 20 CM DELTAPAQ PLATINUM MICROCOIL WAS NOT ABLE TO BE DETACHED. THE COIL WAS RECAPTURED. DURING AN EMBOLIZATION PROCEDURE OF A 10MM ANEURYSM, SEVERAL COILS WERE INTRODUCED FOR EMBOLIZATION; HOWEVER, TWO COILS COULD NOT BE DETACHED. IT WAS NOTED THAT ONE DELTAPAQ PLATINUM MICROCOIL - (B)(4) COULD NOT BE DETACHED AND THE OTHER BRAND OF COIL IS UNKNOWN. AFTER THE INABILITY TO DETACH THE DELTAPAQ, THE CONNECTING CABLE WAS CHANGED AND THE DETACHMENT CONTROL BOX (DCB) WAS RESTARTED TWO OR THREE TIMES WITHOUT ACHIEVING THE EXPECTED RESULTS. THERE IS NO INFORMATION AVAILABLE REGARDING THE CONNECTING CABLE OR DCB AND IT IS NOT KNOWN IF THEY WERE USED SUCCESSFULLY WITH SUBSEQUENT COILS. THE FOLLOWING CODMAN PRODUCTS WERE USED: ENVOY 6F, PROWLER 1.9, SOFT NEUROSCOUT 14. THE EMBOLIZATION PROCEDURE WAS CONTINUED UNTIL THE END. NO FURTHER PROCEDURAL INFORMATION IS AVAILABLE. AS VIEWED THROUGH THE RETURNED PACKAGING, THE COIL WAS RETURNED DAMAGED AND PROTRUDING OUTSIDE THE SHEATH. IT WAS FOUND THAT THE DETACHMENT FIBER DID NOT RECEIVE HEAT AND MELT. THE DEVICE POSITIONING UNIT (DPU) PASSED ELECTRICAL TESTING. DURING LABORATORY TESTING THE COIL WAS DETACHED ON THE FIRST DETACHMENT CYCLE. THE DETACHMENT FIBER RECEIVED HEAT AND MELTED AS DESIGNED. THE DPU PASSED POST-DETACHMENT ELECTRICAL TESTING. LABORATORY TESTING COULD NOT DUPLICATE THE FIELD COMPLAINT. THEREFORE, THE ROOT CAUSE OF THE COIL UNABLE TO BE DETACHED INSIDE THE ANEURYSM CANNOT BE DETERMINED. IN ADDITION, WITHOUT THE RETURN OF THE COMPLETE DETACHMENT SYSTEM USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS CONTRIBUTED 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. THERE WAS NO DISCREPANCY WITH FUNCTIONAL TESTING FOR DETACHMENT OF THE RETURNED DEVICE. NO CONCLUSION CAN BE MADE REGARDING THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    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 DEVICE IS EXPECTED TO BE RETURNED, BUT HASN'T BEEN RECEIVED YET. THUS ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING THE ANEURYSM EMBOLIZATION PROCEDURE, THERE WERE SEVERAL COILS INTRODUCED FOR EMBOLIZING ANEURYSM OF 10 MM; HOWEVER DURING THE IMPLANTATION OF TWO OF THE PRESENTED COILS, IT WAS NOT POSSIBLE TO RELEASE THEM AND THUS THE SURGEON PROCEEDED TO RECAPTURE THE COILS. IT WAS NOTED THAT ONE OF THEM WAS A DELTAPAQ PLATINUM MICROCOIL- (B)(4) AND ANOTHER BRAND OF COIL IS UNKNOWN. THE CORRECTIVE ACTIONS TAKEN DURING THIS EVENT INCLUDED CHANGE OF THE CONNECTOR CABLE; AND RESTART THE RELEASING BOX TWO OR THREE TIMES, WITHOUT ACHIEVING THE EXPECTED RESULTS. DURING THE PROCEDURE, OTHER CODMAN DEVICES USED WERE ENVOY 6F, PROWLER 1.9, AND SOFT NEUROSCOUT 14. EVENTS WERE SUBMITTED AND THE EMBOLIZATION PROCEDURE WAS CONTINUED UNTIL THE END. THE DEVICE PROBLEM OCCURRED DURING USE IN PATIENT. THERE IS NO AVAILABLE TEST OR LAB DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135077 DELTAPAQ - PLATINUM MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G14209

    Patients

    Seq Age Sex Outcome Treatment
    1