BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTIPAQ - CERECYTE MICROCOIL

    MDR report key: 2853687 · Received December 3, 2012

    Report

    Report Number
    2954740-2012-00801
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 20, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K022420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DURING A PULMONARY AVF EMBOLIZATION THE LOCATION OF THE MARKER OF THE ULTIPAQ (CFS10030630/J10032) WAS FOUND DIFFERENT THAN USUAL. THE DECISION WAS MADE TO REMOVE THE ULTIPAQ TO AVOID THE RISK OF DETACHMENT FAILURE. THE ULTIPAQ WAS SAFELY REMOVED FROM THE PATIENT SUCCESSFULLY AND THE PROCEDURE WAS CONTINUED USING OTHER PRODUCTS. IT IS UNKNOWN IF THE MICROCATHETER (DETAIL UNKNOWN) WAS ALSO REPLACED OR NOT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO PATIENT INJURY REPORTED. THERE WAS NO VESSEL CALCIFICATION OR TORTUOSITY. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON THE COMPLAINT PRODUCT BY VISUAL INSPECTION. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. NO FURTHER INFORMATION IS AVAILABLE. THE DEVICE WAS RECEIVED FOR ANALYSIS. AS VIEWED THROUGH THE RETURNED PACKAGING, THE COIL IS UNSHEATHED AND ENTANGLED AROUND THE DEVICE POSITIONING UNIT (DPU) AND SHEATH. IT WAS ALSO OBSERVED UPON RECEIPT THAT THE DISTAL SECTION OF THE DPU WAS SEVERELY BUCKLED. THE COIL WAS ALSO RETURNED SEVERELY DAMAGED. THE COIL'S SOCKET HAS BEEN PUSHED BACK AND DOWN UNDER THE OUTER SHEATH. THE PROXIMAL END OF THE COIL HAS BEEN STRETCHED. DISTAL TO THE COILS STRETCHED SECTION ARE MULTIPLE SECTIONS OF COMPRESSION ON THE COIL. LOCATED PROXIMALLY 1.2CM OFF THE DISTAL TIP OF THE DPU AND AT THE DISTAL TIP OF THE TIP COIL, THERE IS SEVERE BUCKLING AND TWISTING OF THE DPU. THE TWISTED WIRING EXHIBITS THE APPLICATION OF ROTATIONAL TORQUE. THE MARKER BAND WAS FOUND TO BE UNDAMAGED. AFTER THE DAMAGED DPU WAS RE-STRAIGHTENED APPROXIMATELY TO ITS ORIGINAL SHAPE AND LENGTH, THE MARKER BAND WAS FOUND TO HAVE BEEN CORRECTED LOCATED AND FABRICATED. IT IS LOCATED 31.5MM OFF THE DISTAL TIP OF THE DPU. THE RANGE IS 31/32MM. THEREFORE, THE MOST LIKELY ROOT CAUSE OF THE MARKER BAND NOT FOUND TO BE CORRECTLY LOCATED DURING THE PROCEDURE WAS DUE TO THE SEVERE BUCKLING OF THE DPU. THE BUCKLING CAUSED THE DISTANCE FROM THE PROXIMAL END OF THE MARKER BAND TO THE DISTAL TIP OF THE DPU TO APPEAR SHORTENED IN LENGTH TO THE END USER. THE BUCKLING OF THE DPU WAS MOST LIKELY TO HAVE BEEN CAUSED BY DISTAL INTERFERENCE. DEPENDING ON THE LOCATION OF THE COIL WHEN THIS DAMAGE OCCURRED, THE SOURCE OF THIS INTERFERENCE; WHETHER FROM A FIXED OR DETACHED NATURE CANNOT BE EXACTLY DETERMINED. IN ADDITION WITHOUT THE RETURN OF THE UNIDENTIFIED MICROCATHETER USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IT THIS COMPONENT CONTRIBUTED TO THE COMPLAINT EVENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. BASED ON THE ANALYSIS OF THE RETURNED DEVICE IT APPEARS THAT PROCEDURAL FACTORS/DEVICE MANIPULATION RESULTING IN THE BUCKLING DAMAGE TO DISTAL END OF THE DEVICE CONTRIBUTED TO THE MARKERS APPEARING TO BE MISPLACED. THE MARKER BAND ON THE RETURNED DEVICE WAS IN THE CORRECT POSITION PER SPECIFICATIONS. ALTHOUGH THE EXACT CAUSE OF THE DAMAGE TO THE DEVICE CANNOT BE DETERMINED, IT APPEARS RELATED TO PROCEDURAL FACTORS WITH NO INDICATION OF ANY MANUFACTURING DISCREPANCIES. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN. EVALUATION SUMMARY ATTACHED.

    Description of Event or Problem · 1

    THE PROCEDURE WAS COIL EMBOLIZATION OF PULMONARY AVF THAT WAS NOT CALCIFIED AND NOT TORTUOUS. IT WAS REPORTED THAT DURING THE PROCEDURE, LOCATION OF THE MARKER OF THE ULTIPAQ (CFS10030630/J10032, COMPLAINT PRODUCT) WAS FOUND DIFFERENT THAN USUAL. THE PHYSICIAN DECIDED TO REMOVE THE ULTIPAQ TO AVOID THE RISK OF DETACHMENT FAILURE. THE ULTIPAQ WAS SAFELY REMOVED FROM THE PATIENT SUCCESSFULLY, AND THE PROCEDURE WAS CONTINUED USING OTHER PRODUCTS. IT IS UNKNOWN IF THE MICROCATHETER(DETAIL UNKNOWN) WAS ALSO REPLACED OR NOT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THERE WAS NO PATIENT INJURY REPORTED. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON THE COMPLAINT PRODUCT BY VISUAL INSPECTION. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. THE COMPLAINT PRODUCT IS GOING TO BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTIPAQ - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA J10032

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN MICROCATHETER