BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 3172929 · Received June 17, 2013

    Report

    Report Number
    1058196-2013-00161
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 3, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    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 15698775 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE PRODUCT WILL BE RETURNED FOR ANALYSIS, HOWEVER IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE ORBIT GALAXY COMPLEX XTRASOFT COIL 2 X 2 (640CX0202/15790294) WAS STRETCHED DURING INSERTION INTO THE TARGET ANEURYSM. THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. THERE WAS NO FLOW RESTRICTION/REDUCTION DUE TO THE EVENT. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. IT IS UNKNOWN IF THE COIL WAS USED LIKE A GUIDE WIRE TO REPOSITION IN THE MICROCATHETER. THERE WAS RESISTANCE WHEN THE COIL WAS REPOSITIONED. IT IS UNKNOWN IF COIL ENTANGLEMENT WITH PREVIOUSLY PLACED COILS CONTRIBUTED TO THE EVENT. THERE WERE NO DAMAGES NOTED ON THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE EVENT AND THE SAME UNKNOWN MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. A NON-STERILE ORBIT GALAXY COMPLEX XTRASOFT COIL 2 X 2 WAS RECEIVED COILED INSIDE OF PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND SEVERAL KINKS WERE NOTED ON IT. THE INTRODUCER WAS RECEIVED UNZIPPED WITHOUT DAMAGE. THE SUPPORT COIL AND GRIPPER WERE FOUND WITHOUT DAMAGE WHILE THE EMBOLIC COIL WAS FOUND STRETCHED. THE GRIPPER AND THE 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 REPORTED STRETCHED COIL WAS CONFIRMED WITH ANALYSIS. THE CONDITIONS OF THE EMBOLIC COIL AND THE DAMAGES FOUND ON THE DEVICE WERE APPEAR TO HAVE BEEN CAUSED BY APPLICATION OF EXCESSIVE FORCE; HOWEVER, NO CONCLUSION CAN BE MADE. NEITHER THE ANALYSIS NOR THE DEVICE HISTORY RECORDS REVIEW INDICATES A RELATIONSHIP TO THE MANUFACTURING PROCESS. ADDITIONALLY INSPECTIONS ARE IN PLACE TO PREVENT THIS TYPE OF FAILURE FROM LEAVING THE FACILITY. IT WAS REPORTED THAT THE COIL STRETCHED DURING REPOSITIONING AND THAT THERE WAS RESISTANCE DURING REPOSITIONING OF THE COIL. BASED ON THE AVAILABLE INFORMATION NO CONCLUSION CAN BE MADE REGARDING THE ROOT CAUSE; HOWEVER, THE INSTRUCTIONS FOR USE PRECAUTIONS THAT IF EMBOLIC COIL REPOSITIONING IS REQUIRED IN THE VASCULATURE, TAKE SPECIAL CARE UNDER FLUOROSCOPY TO VERIFY THAT A ONE-TO-ONE RELATIONSHIP EXISTS BETWEEN THE DELIVERY TUBE AND THE EMBOLIC COIL DURING RETRACTION. OTHERWISE THE EMBOLIC COIL MAY HAVE BEEN STRETCHED, WHICH COULD LEAD TO PREMATURE DETACHMENT OR COIL FRACTURE. IF A ONE-TO-ONE RELATIONSHIP DOES NOT EXIST, THE INFUSION CATHETER AND THE DETACHABLE COIL SHOULD BE REMOVED AS AN ASSEMBLY AND REPLACED. CLINICAL/PROCEDURAL FACTORS APPEAR TO HAVE CONTRIBUTED TO THE EVENT WITH NO INDICATION OF ANY RELATED MANUFACTURING ISSUES; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE COIL ORBIT MINI COMPLEX FILL 2X2 (637MF0202/15698775) WAS STRETCHED DURING INSERTION INTO THE TARGET ANEURYSM. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. IT IS UNKNOWN IF THE COIL WAS USED LIKE A GUIDE WIRE TO REPOSITION IN THE MICROCATHETER. THERE WAS RESISTANCE WHEN THE COIL WAS REPOSITIONED. THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO DAMAGES NOTED ON THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE EVENT. IT IS UNKNOWN IF COIL ENTANGLEMENT WITH PREVIOUSLY PLACED COILS WAS SUSPECTED TO CONTRIBUTE TO THE EVENT. THERE WAS NO FLOW RESTRICTION/REDUCTION AS A RESULT. THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273577 TRUFILL DCS ORBIT MINI COMPLEX FILL CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 15698775

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROCATHETER (DETAILS UNKNOWN)