BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASH 14 CERE 4MMX8.0CM

    MDR report key: 7922876 · Received October 1, 2018

    Report

    Report Number
    3008114965-2018-00737
    Event Type
    Malfunction
    Date Received
    October 1, 2018
    Date of Event
    September 10, 2018
    Report Date
    September 12, 2018
    Manufacturer
    SEE H.10
    Product Code
    HCG
    UDI-DI
    00878528004486
    PMA / PMN Number
    K072173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE INVESTIGATION FINDING OF THE RETURNED DEVICE. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT AN INTRACRANIAL ANEURYSM, THE CASHMERE 14 CERECYTE COIL 4MM X 8CM COIL (CRC14040830 / S11017) COULD NOT BE DETACHED. THE COIL WAS USED WITH THE ENPOWER DETACHMENT CONTROL BOX WITH ENPOWER CONNECTING CABLE; THE SAME DCB AND CONNECTING CABLE WERE USED TO DETACH SUBSEQUENT COILS IN THE PROCEDURE. IT WAS CONFIRMED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED ON THE DETACHMENT CONTROL BOX. THE LOW BATTERY LIGHT WAS NOT SEEN, AND THE SYSTEM READY LIGHT ILLUMINATED. ALL THE CONNECTIONS WERE PROPERLY FITTED WITHOUT THE APPLICATION OF EXCESSIVE FORCE. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT STILL ATTACHED TO THE DELIVERY SYSTEM; THE COIL WAS NOT STRETCHED WHEN IT WAS REMOVED. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. NO SIGNIFICANT CLINICAL DELAY WAS ASSOCIATED WITH THE ISSUE. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THE REPORTED EVENT. THE CASHMERE 14 CERECYTE COIL WAS RETURNED FOR EVALUATION AND TESTING. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: THE COMPLAINT PRODUCT WAS RECEIVED, AND THE LABEL WAS CHECKED AND CONFIRMED TO MATCH WITH THE COMPLAINT INFORMATION. THE DEVICE WAS RETURNED WITH THE EMBOLIC COIL DETACHED FROM THE DEVICE POSITIONING UNIT (DPU); THE EMBOLIC COIL WAS NOT RETURNED WITH THE DEVICE FOR ANALYSIS. THE DEVICE WAS RETURNED WITH THE RESHEATHING TOOL ADVANCED TO THE GREEN INTRODUCER. THE DPU CORE WIRE WAS OBSERVED TO BE KINKED AT APPROXIMATELY 99 CM FROM THE PROXIMAL END OF THE DEVICE. THE DEVICE WAS THEN INSPECTED UNDER A MICROSCOPE. THE DISTAL OUTER SHEATH WAS OBSERVED TO HAVE NOT BEEN SOFTENED, INDICATING THAT THE DETACHMENT PROCESS WAS NOT INITIATED AND THAT THE EMBOLIC COIL WAS REMOVED MECHANICALLY FROM THE DPU. THE V-NOTCH OF THE RESHEATHING TOOL WAS SEEN UNDAMAGED. THE DEVICE WAS CONNECTED TO MULTIMETER 70042-04D AND ITS RESISTANCE WAS MEASURED TO BE 51.9 ¿ (OHMS), WHICH IS WITHIN SPECIFICATION OF 48.5-56.0 ¿. THE DEVICE WAS THEN CONNECTED TO A LAB ENPOWER DETACHMENT CONTROL BOX (DCB) C38341. THE POWER WAS TURNED ON AND THE SYSTEM READY LIGHT STEADILY ILLUMINATED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT S11017 PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. INVESTIGATION CONCLUSION: THE REPORTED ISSUE THAT THE 4MM X 8CM CASHMERE 14 CERECYTE COIL COULD NOT BE DETACHED DURING THE COIL EMBOLIZATION PROCEDURE WAS NOT CONFIRMED. THE EMBOLIC COIL WAS NOT ATTACHED NOR RETURNED WITH THE DEVICE. AS A RESULT, THE DETACHMENT FUNCTIONAL TEST COULD NOT BE PERFORMED. THE DISTAL OUTER SHEATH HAD NOT BEEN SOFTENED, THE RESISTANCE HEATING (RH) COIL HAD NOT BEEN HEATED INDICATING THAT THE EMBOLIC COIL WAS MECHANICALLY DETACHED, LIKELY FROM APPLIED FORCE. THE RESISTANCE OF THE DEVICE WAS WITHIN SPECIFICATION AND THE SYSTEM READY LIGHT ILLUMINATED WHEN THE DEVICE WAS CONNECTED TO A DCB. THERE IS NOT ENOUGH INFORMATION IN THE COMPLAINT DESCRIPTION TO DETERMINE THE CAUSE OF FAILURE DURING THE PROCEDURE. THE CONNECTING CABLE AND DCB USED IN THE PROCEDURE WERE NOT RETURNED FOR ANALYSIS. WITHOUT THESE ITEMS, A FULL FAILURE ANALYSIS CANNOT BE COMPLETED. 100% OF DEVICES ARE INSPECTED IN-PROCESS FOR KINKS AT THE DPU CORE WIRE AND MEASURED FOR RESISTANCE. IT IS UNLIKELY THAT THE DEVICE LEFT MANUFACTURING WITH THE OBSERVED FAILURES. FAILURE TO DETACH IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THIS DEVICE. THE INSTRUCTION FOR USE (IFU) CONTAINS SEVERAL PRECAUTIONS RELATED TO THIS ISSUE AND INCLUDES INSTRUCTIONS FOR TROUBLESHOOTING THE SITUATION SHOULD IT BE ENCOUNTERED DURING USE. THE REPORTED ISSUE IN THE COMPLAINT WAS NOT CONFIRMED THROUGH FUNCTIONAL ANALYSIS OF THE DEVICE AS THE DEVICE WAS RETURNED WITHOUT THE EMBOLIC COIL ATTACHED. THE DEVICE RESISTANCE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION AS INDICATED BY THE ILLUMINATION OF THE SYSTEM READY LIGHT WHEN THE DEVICE WAS CONNECTED TO A DCB IN THE LAB. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THE EXACT CAUSE OF THE REPORTED FAILURE TO DETACH COULD NOT BE CONCLUSIVELY DETERMINED; A FULL FAILURE ANALYSIS COULD NOT BE PERFORMED DUE WITH THE LIMITED INFORMATION PROVIDED IN THE COMPLAINT, AND WITHOUT THE RETURN OF THE CONNECTING CABLE AND DCB USED DURING THE PROCEDURE. IT IS POSSIBLE THAT THE CIRCUMSTANCES OF THE PROCEDURE AND/OR THE MANIPULATION AND INTERACTION OF THE DEVICES MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE KINKED OBSERVED ON THE DPU CORE WIRE WAS LIKELY RELATED TO THE APPLIED FORCE. DEVICES UNDERGO 100% IN-PROCESS INSPECTION FOR KINKS AT THE DPU CORE WIRES; RESISTANCE IS ALSO MEASURED. THUS, IT IS UNLIKELY THAT THE DEVICE LEFT MANUFACTURING WITH THE OBSERVED KINKED NOTED ON THE DPU CORE WIRE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). PRODUCT WAS RECEIVED AND IS PENDING EVALUATION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT ONCE EVALUATION IS COMPLETED. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT AN INTRACRANIAL ANEURYSM, THE CASHMERE 14 CERECYTE COIL 4MM X 8CM COIL (CRC14040830 / S11017) COULD NOT BE DETACHED. THE COIL WAS USED WITH THE ENPOWER DETACHMENT CONTROL BOX WITH ENPOWER CONNECTING CABLE; THE SAME DCB AND CONNECTING CABLE WERE USED TO DETACH SUBSEQUENT COILS IN THE PROCEDURE. IT WAS CONFIRMED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED ON THE DETACHMENT CONTROL BOX. THE LOW BATTERY LIGHT WAS NOT SEEN, AND THE SYSTEM READY LIGHT ILLUMINATED. ALL THE CONNECTIONS WERE PROPERLY FITTED WITHOUT THE APPLICATION OF EXCESSIVE FORCE. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT STILL ATTACHED TO THE DELIVERY SYSTEM; THE COIL WAS NOT STRETCHED WHEN IT WAS REMOVED. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. NO SIGNIFICANT CLINICAL DELAY WAS ASSOCIATED WITH THE ISSUE. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765596 CASH 14 CERE 4MMX8.0CM NEUROVASCULAR EMBOLIZATION DEVICE HCG SEE H.10 S11017 00878528004486

    Patients

    Seq Age Sex Outcome Treatment
    1