BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPAQ - CERECYTE MICROCOIL

    MDR report key: 2933939 · Received January 29, 2013

    Report

    Report Number
    2954740-2013-00025
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 9, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K080437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DAMAGES WERE NOTICED ON THE DELIVERY SYSTEMS OR COILS AFTER REMOVING FROM THE PATIENT (COIL-STRETCHED/UNRAVELED, KINK, BEND, FRACTURE, SEPARATED, ETC), OR DELIVERY SYSTEM/INTRODUCER (KINK, BEND, FRACTURE, SEPARATED, ETC), AND HE COILS REMAINED ATTACHED TO THE DELIVERY SYSTEMS. NO SERIOUS INJURY WAS REPORTED, AND THE DEVICES WILL BE RETURNED FOR ANALYSES. NO FURTHER INFORMATION WAS PROVIDED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (M10001) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: PLEASE NOTE THAT THE EVENT DESCRIPTION SUBMITTED IN FOLLOW-UP 1 WAS INCORRECTLY ENTERED, PLEASE SEE CORRECT EVENT DESCRIPTION BELOW: DURING THE PROCEDURE TO TREAT AN ANEURYSM OF THE ACOM (8.6 - 9.5MM), RESISTANCE OCCURRED WITH AN ORBIT COIL ((B)(4)) AND THE DELTA MICROCOIL ((B)(4)) WOULD NOT DETACH. IT WAS REPORTED THAT PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED, AND THE DCB WAS PRESSED THREE TIMES TO DETACHED THE COIL. THERE WAS NO INDICATION THAT THERE WAS A PROBLEM WITH THE CONNECTING CABLE OR DETACHMENT CONTROL BOX USED WITH THE COIL, AND AFTER THE EVENT, THE SAME CABLE AND DCB WERE USED WITH THE NEXT DEVICE. IT WAS VERIFIED THAT ALL CONNECTIONS OF THE MICROCOIL DELIVERY SYSTEM WERE FULLY CONNECTED (DEVICE POSITIONING UNIT TO CONNECTING CABLE, CONNECTING CABLE TO DETACHMENT CONTROL BOX), AND NO FAULTS WERE NOTED WITH THE DETACHMENT CONTROL BOX AT ANY TIME. THE DETACH CYCLE LIGHT NEXT TO THE BUTTON ILLUMINATE AND INTERMITTENT TONE WILL SOUND DURING THE ATTEMPTED DETACHMENTS. NO RESISTANCE OCCURRED DURING INSERTION, ADVANCEMENT, POSITIONING, OR REMOVAL OF THE COIL DELIVERY SYSTEM. NO ATTEMPTS WERE MADE TO DETACH THE COIL MANUALLY. AFTER THE EVENT, THE SAME MICROCATHETER WAS USED WITH THE NEXT DEVICES. DURING ADVANCING OF THE ORBIT COIL, RESISTANCE OCCURRED IN THE MIDDLE SECTION OF AN UNKNOWN MICROCATHETER. THE COIL WAS REMOVED, AND A GUIDEWIRE WAS USED TO EXCHANGE THE MICROCATHETER AND MAINTAINED TARGET SITE. DURING THE EVENT WITH THE ORBIT COIL, THE INTRODUCER WAS SEATED CORRECTLY IN THE MICROCATHETER HUB, AND ALL LABELING GUIDELINES WERE FOLLOWED FOR INSERTING THE COIL VIA THE Y CONNECTOR. A DEDICATED AND CONSTANT SALINE SOURCE WAS UTILIZED AT ALL TIMES WITH THE MICROCATHETER. AFTER THE COIL WOULD NOT ADVANCE, NO ADDITIONAL FORCE, TORQUE OR MANIPULATION WAS USED TO FURTHER ADVANCE THE DEVICE. THE MICROCATHETER WAS NOT RE-SHAPED. NO DAMAGES WERE NOTICED ON THE DELIVERY SYSTEMS OR COILS AFTER REMOVING FROM THE PATIENT (COIL-STRETCHED/UNRAVELED, KINK, BEND, FRACTURE, SEPARATED, ETC), OR DELIVERY SYSTEM/INTRODUCER (KINK, BEND, FRACTURE, SEPARATED, ETC), AND HE COILS REMAINED ATTACHED TO THE DELIVERY SYSTEMS. NO SERIOUS INJURY WAS REPORTED, AND THE DEVICES WILL BE RETURNED FOR ANALYSES. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    DURING THE PROCEDURE TO TREAT AN ANEURYSM OF THE ACOM (8.6*9.5MM), RESISTANCE OCCURRED WITH AN ORBIT COIL AND THE DELTA COIL WOULD NOT DETACH. IT WAS REPORTED THAT PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED, AND THE DCB WAS PRESSED THREE TIMES TO DETACHED THE COIL. THERE WAS NO INDICATION THAT THERE WAS A PROBLEM WITH THE CONNECTING CABLE OR DETACHMENT CONTROL BOX USED WITH THE COIL, AND AFTER THE EVENT, THE SAME CABLE AND DCB WERE USED WITH THE NEXT DEVICE. IT WAS VERIFIED THAT ALL CONNECTIONS OF THE MICROCOIL DELIVERY SYSTEM WERE FULLY CONNECTED (DEVICE POSITIONING UNIT TO CONNECTING CABLE, CONNECTING CABLE TO DETACHMENT CONTROL BOX), AND NO FAULTS WERE NOTED WITH THE DETACHMENT CONTROL BOX AT ANY TIME. THE DETACH CYCLE LIGHT NEXT TO THE BUTTON ILLUMINATE AND INTERMITTENT TONE WILL SOUND DURING THE ATTEMPTED DETACHMENTS. NO RESISTANCE OCCURRED DURING INSERTION, ADVANCEMENT, POSITIONING, OR REMOVAL OF THE COIL DELIVERY SYSTEM. NO ATTEMPTS WERE MADE TO DETACH THE COIL MANUALLY. AFTER THE EVENT, THE SAME MICROCATHETER WAS USED WITH THE NEXT DEVICES. DURING ADVANCING OF THE ORBIT COIL, RESISTANCE OCCURRED IN THE MIDDLE SECTION OF AN UNKNOWN MICROCATHETER. THE COIL WAS REMOVED, AND A GUIDEWIRE WAS USED TO EXCHANGE THE MICROCATHETER AND MAINTAINED TARGET SITE. DURING THE EVENT WITH THE ORBIT COIL, THE INTRODUCER WAS SEATED CORRECTLY IN THE MICROCATHETER HUB, AND ALL LABELING GUIDELINES WERE FOLLOWED FOR INSERTING THE COIL VIA THE Y CONNECTOR. A DEDICATED AND CONSTANT SALINE SOURCE WAS UTILIZED AT ALL TIMES WITH THE MICROCATHETER. AFTER THE COIL WOULD NOT ADVANCE, NO ADDITIONAL FORCE, TORQUE OR MANIPULATION WAS USED TO FURTHER ADVANCE THE DEVICE. THE MICROCATHETER WAS NOT RE-SHAPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39616 DELTAPAQ - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA M10001

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR UNKNOWN MICROCATHETER, CABLE & DCB.