BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    MDR report key: 2925385 · Received January 22, 2013

    Report

    Report Number
    1058196-2013-00027
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 4, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A POSTERIOR COMMUNICATING (PCOM) ARTERY ANEURYSM WHEN DELIVERING THE SECOND COIL, A 4X10 TRUFILL DCS ORBIT MINI COMPLEX FILL ((B)(4)) USING AN ESCHELON 10 MICROCATHETER, THE STRETCHED WHEN PART OF THE COIL WAS IN THE ANEURYSM. THE EVENT OCCURRED DURING REPOSITIONING OF THE MICROCATHETER OVER THE DEPLOYED COIL. THE IFU CAUTIONS THAT REPOSITIONING THE INFUSION CATHETER WHILE THE COIL IS DEPLOYED MAY LEAD TO DAMAGE AND/OR PREMATURE DETACHMENT OF THE EMBOLIC COIL. THE COIL WAS REMOVED FROM THE MICROCATHETER STILL ATTACHED TO THE DELIVERY SYSTEM WHILE THE MICROCATHETER REMAINED IN POSITION. THE COIL WAS INSPECTED OUTSIDE OF THE PATIENT'S BODY; HOWEVER THE DELIVERY WIRE WAS INADVERTENTLY BROKEN AT THIS TIME. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. THERE WERE NO DAMAGES NOTED ON THE DEVICE PRIOR TO USE. THE VESSEL WAS NOT TORTUOUS OR CALCIFIED. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER AND THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER. A NON-STERILE ORBIT RDFL COMPLEX MINI COIL SYSTEM WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND IT WAS FOUND SEPARATED. THE EDGES OF THE BROKEN SECTION OF THE HYPOTUBE APPEAR AS IF IT WAS KINKED BEFORE IT SEPARATED. ADDITIONALLY A KINK WAS NOTED. THE INTRODUCER WAS UNZIPPED AND IT WAS INSPECTED, NO DAMAGES WERE NOTED. THE EMBOLIC COIL, SUPPORT COIL AND GRIPPER WERE RECEIVED INSIDE THE INTRODUCER; EMBOLIC COIL WAS FOUND STRETCHED. THE GRIPPER AND SUPPORT COIL WERE FOUND IN GOOD CONDITIONS. SOME WAVES WERE FOUND ON THE PRODUCT BUT THESE APPEAR TO HAVE POSSIBLY OCCURRED DURING THE HANDLING OF THE UNIT WHEN THIS WAS RETURN FOR EVALUATION. THE EMBOLIC COIL AND THE GRIPPER WERE INSPECTED UNDER MICROSCOPE; THE STRETCHED EMBOLIC WAS CONFIRMED. THE GRIPPER WAS IN GOOD CONDITIONS. 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. THE CAUSE OF THE DAMAGES FOUND ON THE EMBOLIC COIL CANNOT BE DETERMINED BASED ON THE ANALYSIS. HOWEVER, THE PROCEDURAL FACTOR OF REPOSITIONING THE MICROCATHETER OVER THE PARTIALLY DEPLOYED COIL, WHICH THE INSTRUCTIONS FOR USE CAUTIONS MAY LEAD TO COIL DAMAGE, IS A LIKELY CONTRIBUTING PROCEDURAL FACTOR MAY HAVE CONTRIBUTED. BASED ON THE ANALYSIS WHICH SHOWS EVIDENCE OF KINKING OF THE HYPOTUBE PRIOR TO THE SEPARATION AND THE REPORT THAT THE DEVICE WAS INADVERTENTLY BROKEN IN TWO PIECES AFTER PROCEDURAL USE, POST PROCEDURAL HANDLING CAUSED THE SEPARATION. WITH REVIEW OF THE ANALYSIS AND DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE REPORTED EVENTS. ADDITIONALLY INSPECTIONS ARE IN PLACE TO PREVENT THESE KINDS OF DAMAGES FROM LEAVING THE FACILITY; THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    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 15379631 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE PRODUCT WAS RECEIVED FOR ANALYSIS, BUT IT HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. . CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ECHELON 10 MICRO-CATHETER; UNKNOWN COIL.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED THE FIRST COIL USING AN ECHELON 10 MICRO-CATHETER. WHEN HE IMPLANTED THE SECOND COIL (TRUFILL DCS ORBIT MINI COMPLEX FILL 638MF0410), THE COIL WAS STRETCHED (PART OF THE COIL WAS ALREADY IN THE ANEURYSM). THEN THE PHYSICIAN WITHDREW THE COIL, THE MICRO-CATHETER WAS NOT REMOVED WITH THE COIL. AFTER THAT, THE PHYSICIAN INSPECTED THE COIL OUTSIDE OF THE PATIENT'S BODY. THE DELIVERY GUIDEWIRE WAS BROKEN INADVERTENTLY. THE PHYSICIAN CHANGED TO ANOTHER COIL TO COMPLETE THE PROCEDURE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICRO-CATHETER. THERE WAS NO PATIENT INJURY REPORTED. THERE WERE NO DAMAGES NOTED ON THE COIL PRIOR TO USE. THERE WERE NO DAMAGES NOTED ON THE MICRO-CATHETER PRIOR TO AND AFTER USE. THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MICRO-CATHETER. THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS REMOVED. THE PATIENT HAD PCOM ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30642 TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 15379631

    Patients

    Seq Age Sex Outcome Treatment
    1