BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 2040239 · Received April 5, 2011

    Report

    Report Number
    1058196-2011-00140
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 13, 2011
    Report Date
    March 13, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A NON-STERILE TRUFILL DCS WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND NO DAMAGES WERE FOUND ON IT. THE INTRODUCER WAS RECEIVED ZIPPED WITHOUT DAMAGE. THE SUPPORT COIL, GRIPPER AND THE EMBOLIC COIL WERE RECEIVED INSIDE OF THE INTRODUCER. THE GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE, THE GRIPPER WAS FOUND WITHOUT DAMAGE WHILE THE EMBOLIC COIL WAS FOUND STRETCHED. 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" POSITIONING DIFFICULTY COULD NOT BE EVALUATED. THE FAILURE REPORTED BY THE COSTUMER AS "COIL - UNRAVELED/STRETCHED" WAS CONFIRMED DURING THE ANALYSIS. THE CAUSE OF THE COIL STRETCHED COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED COULD BE RELATED TO THE MANUFACTURING PROCESS; ADDITIONALLY INSPECTIONS ARE IN PLACE AS THAT PREVENTS THESE KINDS OF FAILURES LEAVING FROM THE FACILITY. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    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 15196966 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. 24 UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. THE NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THE DHR REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS INCLUDING INSPECTION RESULTS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING AN ANEURYSM COIL EMBOLIZATION THE ORBIT MINI COMPLEX FILL 3 X 6 COIL HAD POSITIONING DIFFICULTY AND THEN UNRAVELED/STRETCHED. DURING A COIL EMBOLIZATION PROCEDURE OF AN ACOM ANEURYSM, AFTER PLACING TWO COILS (1ST - 637CF0515 AND 2ND - 637MF0410), THE THIRD ORBIT MINI COMPLEX FILL 3X6 COIL (637MF0306) FELT SOME PUSHBACK WHEN REPOSITIONING AND THE COIL STRETCHED. APPARENTLY, WHEN THE DOCTOR TRIED TO POSITION THE COIL, THERE WAS SOME RESISTANCE. AFTER THE COIL STRETCHED, THE DELIVERY SYSTEM /COIL WAS REMOVED WHILE KEEPING THE MICROCATHETER AT THE TARGET SITE. THE PROCEDURE WAS COMPLETED USING A 2.5 X 4.5 MM ORBIT COIL (637MF2545). AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE (MC) MICROCATHETER AT ALL TIMES. THE MC WAS NOT RE-SHAPED PRIOR TO USE. AN EV# REMODELING PRODUCT WAS USED DURING THE PROCEDURE. THE TARGET SITE WAS A NORMAL ACOM WITH A SACCULAR ANEURYSM THAT MEASURE 6 X 4 AND NECK OF 3MM. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICE, AND THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. A NON-STERILE TRUFILL DCS WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND NO DAMAGES WERE FOUND ON IT. THE INTRODUCER WAS RECEIVED ZIPPED WITHOUT DAMAGE. THE SUPPORT COIL, GRIPPER AND THE EMBOLIC COIL WERE RECEIVED INSIDE OF THE INTRODUCER. THE GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE, THE GRIPPER WAS FOUND WITHOUT DAMAGE WHILE THE EMBOLIC COIL WAS FOUND STRETCHED. 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 POSITIONING DIFFICULTY'' COULD NOT BE EVALUATED. THE FAILURE REPORTED BY THE COSTUMER AS ''COIL UNRAVELED/STRETCHED'' WAS CONFIRMED DURING THE ANALYSIS. THE CAUSE OF THE COIL STRETCHED COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED COULD BE RELATED TO THE MANUFACTURING PROCESS; ADDITIONALLY INSPECTIONS ARE IN PLACE AS PER 637MI021 REV. 24 THAT PREVENT THIS KIND OF FAILURES LEAVING FROM THE FACILITY. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THE COMPLAINT OF COIL UNRAVELED/STRETCHED WAS CONFIRMED ON ANALYSIS; HOWEVER, THE EXACT CAUSE OF THE CONFIRMED FAILURE COULD NOT BE DETERMINED. THE COMPLAINT OF POSITIONING DIFFICULTY COULD NOT BE EVALUATED. THERE IS NO EVIDENCE OF MANUFACTURING OR DESIGN ISSUES THAT CONTRIBUTED TO THE EVENT. INSPECTIONS ARE IN PLACE TO ENSURE THAT NO DAMAGED PRODUCTS LEAVE THE FACILITY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT LESION CHARACTERISTICS AND PROCEDURAL ISSUES, SPECIFICALLY THE FACT THAT THIS WAS THE THIRD COIL INSERTED WITHIN THE ANEURYSM AND MAY HAVE INTERACTED WITH THE PREVIOUSLY PLACED COILS, MAY HAVE CONTRIBUTED TO THE CONFIRMED UNRAVELED/STRETCHED FAILURE AND REPORTED PLACEMENT DIFFICULTY.

    Additional Manufacturer Narrative · 1

    DURING A COIL EMBOLIZATION PROCEDURE OF THE ACOM ANEURYSM, AFTER PLACING TWO COILS ( 1ST - (B)(4) AND 2ND - (B)(4)), THE THIRD ORBIT MINI COMPLEX FILL 3X6 COIL ((B)(4)) FELT SOME PUSHBACK WHEN REPOSITIONING AND THE COIL STRETCHED. APPARENTLY, WHEN THE DOCTOR TRIED TO POSITION THE COIL , THERE WAS SOME RESISTANCE. AFTER THE COIL STRETCHED, THE DELIVERY SYSTEM /COIL WAS REMOVED WHILE KEEPING THE MICROCATHETER AT THE TARGET SITE. THE PROCEDURE WAS COMPLETED USING A 2.5 X 4.5 MM ORBIT COIL ((B)(4)). AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE (MC) MICROCATHETER AT ALL TIMES. THE MC WAS NOT RE-SHAPED PRIOR TO USE. AN EV# REMODELING PRODUCT WAS USED DURING THE PROCEDURE. THE TARGET SITE WAS A NORMAL ACOM WITH A SACCULAR ANEURYSM THAT MEASURE 6 X 4 AND NECK OF 3 MM. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICE, AND THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING A COIL EMBOLIZATION PROCEDURE OF THE ACOM ANEURYSM, AFTER PLACING TWO COILS ( 1ST - (B)(4) AND 2ND - (B)(4)), THE THIRD ORBIT MINI COMPLEX FILL 3X6 COIL (B)(4) FELT SOME PUSHBACK WHEN REPOSITIONING AND THE COIL STRETCHED. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

    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 15196966

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR