BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    MDR report key: 2212735 · Received August 16, 2011

    Report

    Report Number
    1058196-2011-00413
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 25, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A COIL EMBOLIZATION PROCEDURE, THE ORBIT RDFL COMPLEX MINI COIL ((B)(4)) DETACHED IN THE ANEURYSM WITHOUT USING DETACHMENT SYRINGE. THE MARKERS ON THE ORBIT COIL DELIVERY SYSTEM OR THE PROWLER MICROCATHETER WERE NOT SEEN DURING PLACEMENT, SINCE THE ATTENTIONS WAS FOCUS ON POSITIONING THE COIL WITHIN THE ANEURYSM. THE PHYSICIAN WAS WORKING IN ONLY ONE PLANE OF THE IMAGING SYSTEM AND INDICATED THAT THE DELIVERY SYSTEM WAS PUSHED TOO FAR CAUSING THE MARKERS TO ACTUALLY BE IN THE COIL MASS AND THEREFORE UNSEEN. THIS CAUSED THE COIL TO BE PUSHED INTO THE ANEURYSM PAST THE USUAL POINT CAUSING DETACHMENT WITHOUT PRESSURIZING THE SYRINGE. THEREFORE, IT WAS REPORTED THAT THE DELIVERY SYSTEM AND MICROCATHETER ARE BEING RETURNED TO CONFIRM WHETHER THE MARKERBANDS ARE PRESENT; HOWEVER, WITH ADDITIONAL INFORMATION, ONLY THE COIL IS AVAILABLE FOR ANALYSIS. THE COIL WAS POSITIONED MANY TIMES WITH REPORT OF ADDITIONAL TORQUE/MANIPULATION DURING PLACEMENT OF THE COIL. IT IS NOT KNOWN IF THE MICROCATHETER WAS REPOSITIONED OVER THE DEPLOYED COIL WHICH THE INSTRUCTIONS FOR USE (IFU) CAUTIONS MAY LEAD TO COIL DAMAGE OR DETACHMENT. THE PATIENT WAS NOT HARMED AND IT WAS A SUCCESSFUL OUTCOME. AFTER THE EVENT, NO DAMAGES WERE NOTICED ON THE SYRINGE OR DELIVERY SYSTEM. PRIOR TO PLACING THE COILS, AN ENTERPRISE STENT WAS DEPLOYED SUCCESSFULLY. A CONSTANT AND DEDICATED HEPARINIZED SALINE SOURCE WAS UTILIZED AT ALL TIMES. OTHER THAN THE MARKER, NO OTHER ISSUES WERE NOTED WITH THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE MICROCATHETER DISTAL TIP WAS NOT RE-SHAPED. THE TARGET SITE WAS THE CAROTID ARTERY WITH A WIDE NECK SACCULAR ANEURYSM THAT MEASURE 3.5MM, NECK 3.5MM, AND A NECK TO SAC RATIO OF 1:1. ONE NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED IN A PLASTIC BAG, THE HYPOTUBE WAS FOUND KINKED AND BENT, THE UNIT WAS COMPLETELY UNZIPPED, NO OTHER ANOMALIES WERE NOTED. THE GRIPPER AND SUPPORT COIL WERE FOUND OUTSIDE THE INTRODUCER. THE EMBOLIC COIL WAS NOT RECEIVED; AS REPORTED IT WAS DETACHED. GRIPPER AND MARKER BANDS WERE OBSERVED UNDER THE MICROSCOPE; THE EMBOLIC COIL WAS FOUND BROKEN AND SEPARATED AND IT WAS NOTED THAT THE HEADPIECE WAS STILL ATTACHED TO THE GRIPPER; THE SOLDERED SECTION BETWEEN HEADPIECE AND THE COIL LOOPS WAS NOT FRACTURED INDICATING THAT THE SOLDER HAD A GOOD ADHESION TO THE HEADPIECE. ADDITIONALLY A COUPLE OF WAVES WERE NOTED IN THE MIDDLE OF THE GRIPPER; NO OTHER ANOMALIES WERE NOTED. SUPPORT COIL WAS INSPECTED AND MARKER BANDS WERE FOUND IN THEIR CORRECT PLACE WITHOUT DAMAGE. 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. BASED ON THE ANALYSIS, THE COIL DID NOT DETACH FROM THE GRIPPER; IT SEPARATED FROM THE HEADPIECE. THE MARKER BANDS WERE FOUND IN THE CORRECT POSITION WITHOUT DAMAGE. THE ROOT CAUSE OF THE REPORTED EVENT AND THE CAUSE OF THE DAMAGES FOUND ON THE UNIT COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER THE ANALYSIS AND THE DHR REVIEW INDICATES THAT THE DEVICE DID NOT PRESENT ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD CONTRIBUTE TO THE EVENT AS REPORTED. BASED ON THE AVAILABLE INFORMATION AND ANALYSIS OF THE DEVICE, IT APPEARS THAT PROCEDURAL FACTORS OF ADVANCING THE COIL PAST THE DETACHMENT POSITION AS OUTLINED IN THE IFU AND FOCUS ON THE DISTAL COIL POSSIBLY CONTRIBUTED TO THE REPORTED EVENT. THE IFU WARNS THAT INCORRECT MARKER BAND ALIGNMENT MAY RESULT IN EXCESSIVE FORCES ON THE TREATMENT SITE OR INAPPROPRIATE EMBOLIC COIL PLACEMENT. IT FURTHER WARNS TO NEVER ADVANCE THE MARKER BANDS OF THE DELIVERY TUBE PAST THE MARKER BAND OF THE INFUSION CATHETER AS THIS RISKS DAMAGING THE VESSEL AND DISPLACING THE EMBOLIC COIL. THE PROWLER WAS NOT RETURNED FOR EVALUATION; THEREFORE CONFIRMATION OF THE MARKER BANDS COULD NOT BE MADE; HOWEVER, THERE WAS NO DISCREPANCY WITH THE RETURNED ORBIT DELIVERY SYSTEM. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN. THIS IS 1 OF 2 PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00413 AND 1058196-2011-00414.

    Additional Manufacturer Narrative · 1

    DURING A COIL EMBOLIZATION PROCEDURE, THE ORBIT RDFL COMPLEX MINI COIL ((B)(4)) DETACHED IN THE ANEURYSM WITHOUT USING DETACHMENT SYRINGE. THE MARKERS ON THE COIL OR THE PROWLER MICROCATHETER WERE NOT SEEN DURING PLACEMENT, SINCE THE ATTENTIONS WAS FOCUS ON POSITIONING THE COIL WITHIN THE ANEURYSM, HOWEVER BOTH, THE COIL AND MICROCATHETER ARE BEING RETURNED FOR ANALYSIS TO CONFIRM THE MARKERS ON THE PRODUCTS. AFTER THE EVENT, NO DAMAGES WERE NOTICED ON THE SYRINGE OR DELIVERY SYSTEM. ADDITIONALLY, THE PHYSICIAN INDICATED THAT COIL MAY HAVE BEEN PUSHED PAST THE MARKER WHICH ALSO MAY HAVE BEEN THE CAUSE OF THE SELF DETACHMENT. THE PATIENT WAS NOT HARMED AND IT WAS A SUCCESSFUL OUTCOME. PRIOR TO PLACING THE COILS, AN ENTERPRISE STENT WAS DEPLOYED SUCCESSFULLY, AND DURING THE PROCEDURE, THE COIL WAS REPOSITIONED MANY TIMES. A CONSTANT AND DEDICATED HEPARINIZED SALINE SOURCE WAS UTILIZED AT ALL TIMES, AND NO ADDITIONAL TORQUE OR MANIPULATION WAS CONDUCTED DURING PLACEMENT OF THE COIL. OTHER THAN THE MARKER, NO OTHER ISSUES WERE NOTED WITH THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE MICROCATHETER DISTAL TIP WAS NOT RE-SHAPED. THE TARGET SITE WAS THE CAROTID ARTERY WITH A WIDE NECK SACCULAR ANEURYSM THAT MEASURE 3.5MM, NECK 3.5MM, AND A NECK TO SAC RATIO OF 1:1. THIS IS 1 OF 2 PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00413 AND 1058196-2011-00414. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: DURING A COIL EMBOLIZATION PROCEDURE, THE ORBIT RDFL COMPLEX MINI COIL ((B)(4)) DETACHED IN THE ANEURYSM WITHOUT USING DETACHMENT SYRINGE. THE MARKERS ON THE COIL OR THE PROWLER MICROCATHETER WERE NOT SEEN DURING PLACEMENT, SINCE THE ATTENTIONS WAS FOCUS ON POSITIONING THE COIL WITHIN THE ANEURYSM, HOWEVER BOTH, THE COIL AND MICROCATHETER ARE BEING RETURNED FOR ANALYSIS TO CONFIRM THE MARKERS ON THE PRODUCTS. AFTER THE EVENT, NO DAMAGES WERE NOTICED ON THE SYRINGE OR DELIVERY SYSTEM. ADDITIONALLY, THE PHYSICIAN INDICATED THAT COIL MAY HAVE BEEN PUSHED PAST THE MARKER WHICH ALSO MAY HAVE BEEN THE CAUSE OF THE SELF DETACHMENT. THE PATIENT WAS NOT HARMED AND IT WAS A SUCCESSFUL OUTCOME. PRIOR TO PLACING THE COILS, AN ENTERPRISE STENT WAS DEPLOYED SUCCESSFULLY, AND DURING THE PROCEDURE, THE COIL WAS REPOSITIONED MANY TIMES. A CONSTANT AND DEDICATED HEPARINIZED SALINE SOURCE WAS UTILIZED AT ALL TIMES, AND ADDITIONAL TORQUE AND MANIPULATION WAS CONDUCTED DURING PLACEMENT OF THE COIL. OTHER THAN THE MARKER, NO OTHER ISSUES WERE NOTED WITH THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE MICROCATHETER DISTAL TIP WAS NOT RE-SHAPED. THE TARGET SITE WAS THE CAROTID ARTERY WITH A WIDE NECK SACCULAR ANEURYSM THAT MEASURE 3.5MM, NECK 3.5MM, AND A NECK TO SAC RATIO OF 1:1. ONE NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED IN A PLASTIC BAG, THE HYPOTUBE WAS FOUND KINKED AND BENT, THE UNIT WAS COMPLETELY UNZIPPED, NO OTHER ANOMALIES WERE NOTED. GRIPPER AND SUPPORT COIL WERE FOUND OUTSIDE THE INTRODUCER. NOTE: EMBOLIC COIL WAS NO RECEIVED. GRIPPER AND MARKER BANDS WERE OBSERVED UNDER THE MICROSCOPE; THE EMBOLIC COIL WAS FOUND BROKEN AND SEPARATED AND IT WAS NOTED THAT THE HEADPIECE WAS STILL ATTACHED TO THE GRIPPER; THE SOLDERED SECTION BETWEEN HEADPIECE AND THE COIL LOOPS WAS NOT FRACTURED SO THIS MEANS THAT THE SOLDER HAD A GOOD ADHESION TO THE HEADPIECE (NOTE: THE REST OF THE EMBOLIC COIL WAS NOT RETURNED FOR ANALYSIS), ALSO A COUPLE OF WAVES WERE NOTED IN THE MIDDLE OF THE GRIPPER; NO OTHER ANOMALIES WERE NOTED. SUPPORT COIL WAS INSPECTED AND MARKER BANDS WERE FOUND IN THEIR CORRECT PLACE WITHOUT DAMAGE. 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. THE FAILURE REPORTED BY THE COSTUMER AS "COIL PREMATURE DETACHMENT-DURING PLACEMENT" WAS NOT CONFIRMED SINCE HEADPIECE WAS FOUND STILL ATTACHED TO THE GRIPPER. THE FAILURE REPORTED BY THE COSTUMER AS "MARKER BAND MISSING COMPONENT" WAS NOT CONFIRMED, THE MARKER BANDS WERE FOUND IN THEIR PLACE WITHOUT DAMAGE. THE ROOT CAUSE OF THE EVENT EXPERIENCED BY THE CUSTOMER AND THE CAUSE OF THE DAMAGES FOUND ON THE UNIT COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER THE ANALYSIS AND THE DHR REVIEW INDICATES THAT THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD CONTRIBUTE TO THE EVENT AS REPORTED. IT IS POSSIBLE THAT PROCEDURAL FACTORS OR HANDLING MAY HAVE CONTRIBUTED WITH THE REPORTED CONDITION SINCE THE RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT; ADDITIONALLY INSPECTIONS ARE IN PLACE THAT PREVENTS THESE KINDS OF DAMAGES LEAVING FROM THE FACILITY, THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THIS IS 1 OF 2 PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00413 AND 1058196-2011-00414. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS IS 1 OF 2 PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORT 1058196-2011-00413 AND 1058196-2011-00414. THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING A COIL EMBOLIZATION PROCEDURE, THE ORBIT RDFL COMPLEX MINI COIL (638MF0410/ 15408272) DETACHED IN THE ANEURYSM WITHOUT USING DETACHMENT SYRINGE. THE MARKERS ON THE COIL OR THE PROWLER MICROCATHETER WERE NOT SEEN DURING PLACEMENT, SINCE THE ATTENTIONS WAS FOCUS ON POSITIONING THE COIL WITHIN THE ANEURYSM, HOWEVER BOTH, THE COIL AND MICROCATHETER ARE BEING RETURNED FOR ANALYSIS TO CONFIRM THE MARKERS ON THE PRODUCTS. AFTER THE EVENT, NO DAMAGES WERE NOTICED ON THE SYRINGE OR DELIVERY SYSTEM. ADDITIONALLY, THE PHYSICIAN INDICATED THAT COIL MAY HAVE BEEN PUSHED PAST THE MARKER WHICH ALSO MAY HAVE BEEN THE CAUSE OF THE SELF DETACHMENT. THE PATIENT WAS NOT HARMED AND IT WAS A SUCCESSFUL OUTCOME. PRIOR TO PLACING THE COILS, AN ENTERPRISE STENT WAS DEPLOYED SUCCESSFULLY, AND DURING THE PROCEDURE, THE COIL WAS REPOSITIONED MANY TIMES. THE TARGET SITE WAS THE CAROTID ARTERY WITH A WIDE NECK SACCULAR ANEURYSM THAT MEASURE 3.5MM, NECK 3.5MM, AND A NECK TO SAC RATIO OF 1:1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 15408272

    Patients

    Seq Age Sex Outcome Treatment
    1 PROWLER MICROCATHETER