BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1962036 · Received January 17, 2011

    Report

    Report Number
    1058196-2011-00028
    Event Type
    Injury
    Date Received
    January 17, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 20, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE COIL EMBOLIZATION PROCEDURE WHEN THE 2X2 TRUFILL DCS MINI COMPLEX FILL COIL (637MF0202) WAS PULLED BACK IT UNRAVELED. WITH ATTEMPT TO REMOVE AS A UNIT WITH THE MICROCATHETER (MC) THE COIL BECAME STUCK IN THE TIP OF THE ENVOY GUIDING CATHETER AND PREMATURELY DETACHED. A SENTRY/BOSTON SCIENTIFIC OCCLUSION BALLOON WAS USED AND INFLATED INSIDE THE GUIDING CATHETER TO HOLD THE COIL IN THE CATHETER. THE ENTIRE SYSTEM WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH OTHER NEW PRODUCTS WITHOUT PATIENT INJURY. THERE WERE NO KINKS IN THE MC NOTED THAT MAY HAVE CONTRIBUTED TO THE EVENT. IT IS UNKNOWN IF OTHER COILS WERE ADVANCED THROUGH THE SAME MC AND IF RESISTANCE WAS EXPERIENCED. THE MC WAS NOT REPOSITIONED OVER THE COIL WHILE THE COIL WAS DEPLOYED OR PARTIALLY DEPLOYED OUT OF THE DISTAL END OF THE MC. A ONE TO ONE RELATIONSHIP BETWEEN THE COIL AND DELIVERY TUBE WAS VERIFIED WITH FLUORO PRIOR TO REPOSITIONING. IT IS UNKNOWN IF THE COIL BECAME TANGLED WITH OTHER COILS DURING PLACEMENT OR REPOSITIONING. A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. DCS WAS INSPECTED AND INTRODUCER WAS UNZIPPED WHILE THE SUPPORT COIL AND GRIPPER WERE OUT OF IT. EMBOLIC COIL WAS BROKEN SINCE ONLY THE HEADPIECE WAS RECEIVED ATTACHED TO THE GRIPPER AND THE REST OF THE COIL WAS NOT PROVIDED. KINKS WERE NOTED IN THE HYPOTUBE. NEITHER THE SUPPORT COIL NOR THE GRIPPER PRESENTED DAMAGES. THE OD FROM THE DELIVERY TUBE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. GRIPPER WAS INSPECTED UNDER MICROSCOPE AND IT PRESENTED NO DAMAGES AS WELL PART OF THE BROKEN COIL COULD BE OBSERVED DUE TO THE HEADPIECE WAS STILL ATTACHED TO THE GRIPPER. MICROSCOPIC ANALYSIS SHOWED A WEDGE OF SOLDER STILL ATTACHED TO THE COIL HEADPIECE, IN THE AREA BETWEEN THE COIL LOOPS. THIS INDICATES THAT THE SOLDER HAD GOOD ADHESION TO THE COIL HEADPIECE. FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE CONDITIONS OF THE RECEIVED PRODUCT (EMBOLIC COIL BROKEN). A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15163627 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. DUE TO THE RETURNED CONDITION OF THE DEVICE THE REPORTED UNRAVELED COIL AND RESISTANCE DURING WITHDRAWAL COULD NOT BE EVALUATED. BASED ON THE EVALUATION OF THE RETURNED DEVICE, THE COIL DID NOT PREMATURELY DETACH FROM THE GRIPPER, IT BROKE AT THE HEAD PIECE. IT IS POSSIBLE THAT PROCEDURAL FACTORS CONTRIBUTED TO THE STRETCHING OF THE COIL DURING WITHDRAWAL; HOWEVER, WITH REVIEW OF THE AVAILABLE INFORMATION, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE ROOT CAUSE. IT APPEARS THAT THE STRETCHED CONDITION OF THE COIL, POSSIBLY COMBINED WITH VESSEL CHARACTERISTICS, RESULTED IN THE DAMAGED COIL CATCHING ON THE GUIDING CATHETER WITH ATTEMPT TO WITHDRAW AND CONTINUED WITHDRAWAL RESULTED IN THE COIL SEPARATION AT THE HEADPIECE. PROCEDURAL FACTORS APPEAR TO HAVE CONTRIBUTED TO THE EVENTS. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED DEVICES FROM LEAVING THE FACILITY. BASED ON THE ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFR REPORT # 1058196-2011-00027 AND 1058196-2011-00028.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFR REPORT # 1058196-2011-00027 AND 1058196-2011-00028.

    Description of Event or Problem · 1

    DURING A CEREBRAL ARTERY EMBOLIZATION PROCEDURE, AN EMBOLIC COIL UNRAVELED AND DETACHED EARLY WHEN IT BECAME STUCK IN THE TIP OF THE GUIDING CATHETER. THE VESSEL WAS MILDLY CALCIFIED AND MODERATELY TORTUOUS. THE PATIENT WAS A (B)(6) FEMALE. THE TARGET LESION WAS THE ANTERIOR COMMUNICATING ARTERY (ACA). THE FIRST ORBIT COIL (637MF0201/ LOT 15165671) COULD NOT BE DETACHED. THE CATALOG/LOT NUMBER OF THE DCS SYRINGE WAS UNKNOWN. ALTHOUGH ATTEMPT WAS MADE BY ANOTHER NEW SYRINGE, THE COIL COULD NOT BE DETACHED. THE COIL WAS REMOVED FROM THE PATIENT AND CHANGED TO ANOTHER NEW COIL. THE PROCEDURE CONTINUED. DURING THE PROCEDURE, ANOTHER ORBIT COIL (637MF0202/ LOT 15163627) WAS USED. THE COIL WAS PULLED BACK, BUT IT BECAME UNRAVELED. AS THE COIL WAS BEING REMOVED WITH MICROCATHETER AS A UNIT, THE EMBOLIC COIL BECAME STUCK IN THE TIP OF THE GUIDING CATHETER (ENVOY 5F MPD) AND DETACHED EARLY. AN OCCLUSION BALLOON (SENTRY, BOSTON SCIENTIFIC) WAS USED AND INFLATED INSIDE THE GUIDING CATHETER TO HOLD THE COIL IN THE CATHETER, AND ALL THE SYSTEM WAS REMOVED FROM THE PATIENT SUCCESSFULLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH OTHER NEW PRODUCTS WITHOUT ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT MINI COMPLEX FILL CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 15163627

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R GUIDING CATHETER (ENVOY 5F MPD)