BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPLUSH - CERECYTE MICROCOIL

    MDR report key: 2890301 · Received December 29, 2012

    Report

    Report Number
    2954740-2012-00831
    Event Type
    Malfunction
    Date Received
    December 29, 2012
    Date of Event
    December 17, 2012
    Report Date
    December 18, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K083646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COIL WAS NOT RETURNED. THE OUTER SHEATH SURROUNDING THE RESISTIVE HEATING COIL EXHIBITS MULTIPLE DETACHMENT ATTEMPTS AS STATED IN THE EVENT DESCRIPTION. AFTER CLEANING IT WAS FOUND THAT THE MELTED DETACHMENT FIBER POOLED AROUND AND ABOVE THE RESISTIVE HEATING COIL'S SOCKET RING. NOTE THE VOID ON THE DISTAL END OF THE OUTER SHEATH IN DIRECT LINE WITH THE DETACHMENT FIBER AND SOCKET RING. THE DEVICE POSITIONING UNIT (DPU) PASSED ELECTRICAL TESTING WITH RESISTANCE AT 54.2 OHMS AND THE ENPOWER SYSTEMS GO LIGHT ILLUMINATED. THERE ARE MULTIPLE CONTRIBUTING FACTORS THAT MAY HAVE ACTED IN TANDEM OR SEPARATELY PRODUCING SIMILAR RESULTS. IF THIS IS THE DPU FROM THE FIELD COMPLAINT, THEN THE MOST LIKELY ROOT CAUSE OF THE COILS FAILURE TO DETACH AND THE EVENTUAL UNINTENDED DETACHMENT WAS DUE TO THE MELTING DETACHMENT FIBER ADHERING TO THE COIL. THE MELTING DETACHMENT FIBER TEMPORARILY CAPTURED THE COIL BEFORE RELEASING IT. TWO ADDITIONAL PRIMARY CONTRIBUTING FACTORS TO THE FIELD COMPLAINT WERE DUE TO THE DETACHMENT FIBER POSSIBLY LOSING TENSION AND THE COIL'S SOCKET RING POSSIBLE LOCATION INSIDE THE OUTER SHEATH. ONE FACTOR MAY HAVE BEEN IF THE COIL'S SOCKET RING WAS LODGED DOWN INSIDE THE OUTER SHEATH THAT PRODUCED THE GAP FOUND AT THE DISTAL TIP OF THE OUTER SHEATH'S DIAMETER, THIS WOULD HAVE ALSO LOOSENED THE DETACHMENT FIBER'S TENSION AND WOULD ALSO HAVE CAUSED THE COIL'S SOCKET RING TO BE SEATED AND TEMPORARILY CAPTURED INSIDE THE OUTER SHEATH AT THE VOID THAT WAS FOUND. IN ADDITION, WITHOUT THE RETURN OF THE COMPLAINT DETACHMENT SYSTEM, THE COIL, AND THE SL-10 MICROCATHETER USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS HAD ANY ADDITIONAL CONTRIBUTIONS 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. NOTE: ADDITIONAL INFORMATION AND EVALUATION CODES WILL BE SENT WITHIN 30 DAYS. EVALUATION SUMMARY ATTACHED

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE PROCEDURE WAS COIL EMBOLIZATION OF POSTERIOR CEREBRAL ARTERY ANEURYSM THAT WAS NOT CALCIFIED AND MODERATELY TORTUOUS. ACCESS WAS OBTAINED FROM FEMORAL ARTERY. THE EVENT HAPPENED DURING THE PROCEDURE. IT WAS NOTED THAT THE PHYSICIAN COULD NOT DETACH THE DELTAPLUSH ((B)(4), COMPLAINT PRODUCT) ALTHOUGH PRESSING THE DETACHMENT BUTTON MORE THAN 10 TIMES. TYPE OF THE DETACHMENT CONTROL BOX AND CABLE USED WITH THE PRODUCT WERE NOT PROVIDED, AND IT IS UNKNOWN IF THE FAULT LIGHT WAS SEEN ON THE DETACHMENT CONTROL BOX (DCB) DURING USE. THEN THE PHYSICIAN DECIDED TO REMOVE THE DELTAPLUSH AND HE WAS GENTLY WITHDRAWING IT. THE PROCEDURE WAS CONTINUED USING A NEW PRODUCT ((B)(4), LOT UNKNOWN) AND WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. IT IS UNKNOWN IF THE DCB AND CONTROL CABLE WERE REPLACED OR NOT. IT IS ALSO UNKNOWN HOW MANY COILS WERE SUCCESSFULLY PLACED DURING THE PROCEDURE. THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECTS (KINKS, BENDS ETC) WERE NOTED ON THE PRODUCT BY VISUAL INSPECTION. ALSO NO DAMAGE WAS REPORTED ON THE DEVICE AFTER THE EVENT. THERE WAS NO STRETCHING OR UNINTENDED DETACHMENT OBSERVED IN THE ANEURYSM OR IN THE MICROCATHETER. IT IS UNKNOWN IF THE MICROCATHETER (EXCELSIOR SL10, TYPE UNKNOWN) WAS RE-SHAPED OR NOT. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED AND NO ISSUES WERE NOTED. IT IS ALSO UNKNOWN IF THE COIL REMAINED ATTACHED TO THE DEVICE POSITIONING UNIT (DPU) UPON WITHDRAWAL OF THE COIL. THE COIL WAS NOT RETURNED WITH THE DPU. THE OUTER SHEATH SURROUNDING THE RESISTIVE HEATING COIL ON THE DPU EXHIBITS MULTIPLE DETACHMENT ATTEMPTS AS STATED IN THE EVENT DESCRIPTION. AFTER CLEANING, IT WAS FOUND THAT THE MELTED DETACHMENT FIBER HAD POOLED AROUND AND ABOVE THE RESISTIVE HEATING COIL'S SOCKET RING. A VOID WAS NOTED ON THE DISTAL END OF THE OUTER SHEATH IN DIRECT LINE WITH THE DETACHMENT FIBER AND SOCKET RING. THE DEVICE POSITIONING UNIT (DPU) PASSED ELECTRICAL TESTING WITH RESISTANCE AT 54.2 OHMS AND THE ENPOWER SYSTEM "GO" LIGHT ILLUMINATED AS DESIGNED. THERE ARE MULTIPLE CONTRIBUTING FACTORS THAT MAY HAVE ACTED IN TANDEM OR SEPARATELY PRODUCING THE RESULT DESCRIBED IN THE COMPLAINT. THE MOST LIKELY ROOT CAUSE OF THE COIL FAILURE TO DETACH WAS DUE TO THE MELTING DETACHMENT FIBER ADHERING TO THE COIL. THE MELTING DETACHMENT FIBER TEMPORARILY CAPTURED THE COIL BEFORE RELEASING IT. ADDITIONAL CONTRIBUTING FACTORS TO THE FIELD COMPLAINT MAY HAVE BEEN DUE TO A LOSS OF TENSION OF THE DETACHMENT FIBER AS A RESULT OF THE POSSIBLE LOCATION OF THE SOCKET RING INSIDE THE OUTER SHEATH. IF THE COIL'S SOCKET RING WAS LODGED DOWN INSIDE THE OUTER SHEATH, THIS WOULD HAVE PRODUCED THE GAP FOUND AT THE DISTAL TIP OF THE OUTER SHEATH'S DIAMETER. 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. WITHOUT THE RETURN OF THE COMPLETE DETACHMENT SYSTEM, THE COIL, AND THE SL-10 MICROCATHETER USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS CONTRIBUTED TO THE REPORTED FAILURE OF THE COIL TO DETACH. THE COMPLAINT IS NOT CONFIRMED, THEREFORE, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    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

    THE PROCEDURE WAS COIL EMBOLIZATION OF POSTERIOR CEREBRAL ARTERY ANEURYSM THAT WAS NOT CALCIFIED AND MODERATELY TORTUOUS. ACCESS WAS OBTAINED FROM FEMORAL ARTERY. THE EVENT HAPPENED DURING THE PROCEDURE. IT WAS NOTED THAT THE PHYSICIAN COULD NOT DETACH THE DELTAPLUSH ((B)(4), COMPLAINT PRODUCT) ALTHOUGH PRESSING THE DETACHMENT BUTTON MORE THAN 10 TIMES. TYPE OF THE DETACHMENT CONTROL BOX AND CABLE USED WITH THE PRODUCT WERE NOT PROVIDED. THEN THE PHYSICIAN DECIDED TO REMOVE THE DELTAPLUSH AND HE WAS GENTLY WITHDRAWING IT. THE PROCEDURE WAS CONTINUED USING A NEW PRODUCT ((B)(4), LOT UNKNOWN) AND WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. IT IS UNKNOWN IF THE DETACHMENT CONTROL BOX AND CABLE WERE REPLACED OR NOT. IT IS ALSO UNKNOWN HOW MANY COILS WERE SUCCESSFULLY PLACED DURING THE PROCEDURE. THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON THE PRODUCT BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICE AFTER THE EVENT. THERE WAS NO STRETCHING OR UNINTENDED DETACHMENT OBSERVED IN THE ANEURYSM OR IN THE MICROCATHETER. IT IS UNKNOWN IF THE MICROCATHETER (EXCELSIOR SL10, TYPE UNKNOWN) WAS RE-SHAPED OR NOT. PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED AND NO ISSUES NOTED. IT IS ALSO UNKNOWN IF THE COIL REMAIN ATTACHED TO THE DPU. THE COMPLAINT PRODUCT IS GOING TO BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTAPLUSH - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G13581

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SL-10 MICROCATHETER