BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTAXSFT10 2MM X 6CM

    MDR report key: 13518524 · Received February 11, 2022

    Report

    Report Number
    3008114965-2022-00063
    Event Type
    Injury
    Date Received
    February 11, 2022
    Report Date
    February 11, 2022
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077336
    PMA / PMN Number
    K150319
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PATIENT IDENTIFIER WAS NOT PROVIDED. PROCODE IS KRD/HCG. INITIAL REPORTER PHONE:(B)(6). [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED PROBLEMS WITH THE DETACHMENT OF THE LAST COILS. IT WAS REPORTED THAT IT WAS KNOWN THAT ¿IT DOES NOT WORK THE FIRST TIME. BUT WITH THE LAST ONE, WE HAD SERIOUS PROBLEMS.¿ THE COILS WERE ONLY DETACHED AFTER SEVERAL (APPROXIMATELY 5 ¿ 6) DETACHMENT ATTEMPTS. THE COIL MARKER WAS DELIBERATELY MOVED WELL BEYOND THE SECOND MARKER OF THE MICROCATHETER TO PROMOTE DETACHMENT; EVEN THEN, IT WAS DETACHED ONLY AFTER SEVERAL ATTEMPTS. IN ADDITION, THE DETACHMENT OF ONE OF THE COILS OCCURRED ONLY AFTER RETRACTION WITHIN THE MICROCATHETER. THE COMPLAINT DOCUMENTED TWO (2) COILS IN THIS ORDER: A 2MM X 3CM DELTAXSFT 10 (DLX100203 / K10735) AND A 2MM X 6CM DELTAXSFT 10 (DLX100206 / 30399407). THE PROCEDURE WAS NOT DELAYED BY THE REPORTED ISSUE; IT WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ADDITIONAL INFORMATION WAS RECEIVED ON 10-FEB-2022. THE INFORMATION INDICATED THAT THE ENDOVASCULAR COIL EMBOLIZATION PROCEDURE WAS ON (B)(6) 2022, AND IT WAS TARGETING A CIRCULATORY ELIMINATION OF A BROAD-BASED POLYLOBULATED RIGHT A1/A2 ANEURYSM WITH APICAL DAUGHTER ANEURYSM. BOTH COILS DETACHED ONLY MANY DETACHMENT ATTEMPTS WERE MADE. PER THE ADDITIONAL INFORMATION, THE 2MM X 3CM DELTAXSFT 10 (DLX100203 / K10735) DETACHED IN THE ANEURYSM AFTER 5-6 ATTEMPTS. AFTER 5-6 ATTEMPTS, THE 2MM X 6CM DELTAXSFT 10 (DLX100206 / 30399407) DETACHED IN THE MICROCATHETER; IT ¿DETACHED UNCONTROLLABLY FROM THE PUSHER WIRE AFTER RETRACTION TO CHECK DETACHMENT IN THE DISTAL PORTION OF THE MICROCATHETER AND HAD TO BE PUSHED ¿FREE¿ INTO THE ANEURYSM IN THE HOPE THAT PROTRUSION INTO THE CARRIER VESSEL WOULD NOT OCCUR DUE TO THE POSITION OF THE ALREADY DETACHED COIL, WHICH COULD NO LONGER BE INFLUENCED.¿ THE SAME SL-10® 45° MICROCATHETER (STRYKER) WAS USED FOR THE ENTIRE PROCEDURE. A PRE-DEPLOYMENT ELECTRICAL TEST WAS PERFORMED PRIOR TO USE. ¿FAULT¿ LIGHT WAS SEEN DURING THE CASE. WHEN THE POWER BUTTON WAS PRESSED, ALL LIGHTS ILLUMINATED. THE GREEN SYSTEM READY LIGHT DID ILLUMINATE AND DURING THE DETACHMENT CYCLE, THE AUDIBLE SIGNAL BEEP WAS HEARD. ALL CONNECTIONS APPEARED TO HAVE SEATED PROPERLY WITHOUT APPLIED FORCE. THE PROCEDURE WAS COMPLETED WITH SUFFICIENCY OF CIRCULATORY ELIMINATION OF ANEURYSM. THERE WAS A 5¿10-MINUTE DELAY IN THE PROCEDURE BUT IT WAS NOT CLINICALLY SIGNIFICANT PER THE TREATING PHYSICIAN. BASED ON COMPLAINT INFORMATION, THE DEVICE REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (30399407) 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. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. FAILURE OF THE COIL TO DETACH AND UNINTENDED DETACHMENT DURING RETRIEVAL REQUIRING ADDITIONAL INTERVENTION ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF THE DELTAXSFT10 IN COIL EMBOLIZATION PROCEDURES. FACTORS THAT CAN CONTRIBUTE TO DETACHMENT ISSUES INCLUDE FAILURE TO CONFIRM SECURE CONNECTION OF THE CABLE TO THE DPU AND DETACHMENT CONTROL BOX (DCB). THE INSTRUCTIONS FOR USE (IFU) ADVISES THE USER TO ENSURE THAT THE CONNECTING CABLE IS FULLY SEATED WITH THE CONNECTOR END OF THE DPU WIRE AND OUTPUT CONNECTOR OF THE DCB. THE USER SHOULD VERIFY THAT THE MICROCOIL DELIVERY SYSTEM IS FULLY CONNECTED AND THAT NO FAULTS ARE INDICATED ON THE DCB. IF A FAULT EXISTS, ALL CONNECTIONS SHOULD BE RESEATED BETWEEN THE DPU, THE DCB, AND THE CONNECTING CABLE. IF A FAULT STILL PERSISTS, THE CONNECTING CABLE SHOULD BE REPLACED. IF THIS DOES NOT CORRECT THE ERROR, THE DCB SHOULD BE REPLACED. IF THE MICROCOIL DELIVERY SYSTEM STILL CONTINUES TO HAVE A FAULT, THE MICROCOIL SHOULD BE RETRIEVED AND REPLACED WITH A NEW MICROCOIL SYSTEM. IF AFTER DEPRESSING THE DETACH BUTTON ON THE DCB, THE DCB SHOULD BE REPLACED IF THE LIGHT AND AUDIBLE TONE DO NOT ACTIVATE. ALSO, IF THE SYSTEM READY LIGHT IS NOT ILLUMINATED AND THERE IS NO DETACHMENT AFTER TWO DETACHMENT ATTEMPTS, THE DCB SHOULD BE REPLACED. IF DETACHMENT STILL DOES NOT OCCUR, THE MICROCOIL SYSTEM SHOULD BE CAREFULLY WITHDRAWN AND REPLACED. FOLLOWING FAILED COIL DETACHMENT, IT APPEARS THAT THE COIL UNINTENDEDLY DETACHED IN THE MICROCATHETER DURING RETRIEVAL. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE WITHOUT THE RETURN OF THE ASSOCIATED DEVICES. HOWEVER, THERE ARE CLINICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED RATHER THAN THE DESIGN OR MANUFACTURE OF THE DEVICE. SINCE THE EVENT REQUIRED ADDITIONAL INTERVENTION (I.E., PUSHING THE UNINTENDEDLY DETACHED COIL INTO THE ANEURYSM) TO PRECLUDE PATIENT COMPLICATIONS SUCH AS NON-TARGET SITE EMBOLIZATION, ISCHEMIA, OR INFARCT, THE EVENT MEETS MDR REPORTING CRITERIA WITH THE CLASSIFICATION OF ¿SERIOUS INJURY.¿ 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED PROBLEMS WITH THE DETACHMENT OF THE LAST COILS. IT WAS REPORTED THAT IT WAS KNOWN THAT ¿IT DOES NOT WORK THE FIRST TIME. BUT WITH THE LAST ONE, WE HAD SERIOUS PROBLEMS.¿ THE COILS WERE ONLY DETACHED AFTER SEVERAL (APPROXIMATELY 5 ¿ 6) DETACHMENT ATTEMPTS. THE COIL MARKER WAS DELIBERATELY MOVED WELL BEYOND THE SECOND MARKER OF THE MICROCATHETER TO PROMOTE DETACHMENT; EVEN THEN, IT WAS DETACHED ONLY AFTER SEVERAL ATTEMPTS. IN ADDITION, THE DETACHMENT OF ONE OF THE COILS OCCURRED ONLY AFTER RETRACTION WITHIN THE MICROCATHETER. THE COMPLAINT DOCUMENTED TWO (2) COILS IN THIS ORDER: A 2MM X 3CM DELTAXSFT 10 (DLX100203 / K10735) AND A 2MM X 6CM DELTAXSFT 10 (DLX100206 / 30399407). THE PROCEDURE WAS NOT DELAYED BY THE REPORTED ISSUE; IT WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ADDITIONAL INFORMATION WAS RECEIVED ON 10-FEB-2022. THE INFORMATION INDICATED THAT THE ENDOVASCULAR COIL EMBOLIZATION PROCEDURE WAS ON (B)(6) 2022, AND IT WAS TARGETING A CIRCULATORY ELIMINATION OF A BROAD-BASED POLYLOBULATED RIGHT A1/A2 ANEURYSM WITH APICAL DAUGHTER ANEURYSM. BOTH COILS DETACHED ONLY MANY DETACHMENT ATTEMPTS WERE MADE. PER THE ADDITIONAL INFORMATION, THE 2MM X 3CM DELTAXSFT 10 (DLX100203 / K10735) DETACHED IN THE ANEURYSM AFTER 5-6 ATTEMPTS. AFTER 5-6 ATTEMPTS, THE 2MM X 6CM DELTAXSFT 10 (DLX100206 / 30399407) DETACHED IN THE MICROCATHETER; IT ¿DETACHED UNCONTROLLABLY FROM THE PUSHER WIRE AFTER RETRACTION TO CHECK DETACHMENT IN THE DISTAL PORTION OF THE MICROCATHETER AND HAD TO BE PUSHED ¿FREE¿ INTO THE ANEURYSM IN THE HOPE THAT PROTRUSION INTO THE CARRIER VESSEL WOULD NOT OCCUR DUE TO THE POSITION OF THE ALREADY DETACHED COIL, WHICH COULD NO LONGER BE INFLUENCED.¿ THE SAME SL-10® 45° MICROCATHETER (STRYKER) WAS USED FOR THE ENTIRE PROCEDURE. A PRE-DEPLOYMENT ELECTRICAL TEST WAS PERFORMED PRIOR TO USE. ¿FAULT¿ LIGHT WAS SEEN DURING THE CASE. WHEN THE POWER BUTTON WAS PRESSED, ALL LIGHTS ILLUMINATED. THE GREEN SYSTEM READY LIGHT DID ILLUMINATE AND DURING THE DETACHMENT CYCLE, THE AUDIBLE SIGNAL BEEP WAS HEARD. ALL CONNECTIONS APPEARED TO HAVE SEATED PROPERLY WITHOUT APPLIED FORCE. THE PROCEDURE WAS COMPLETED WITH SUFFICIENCY OF CIRCULATORY ELIMINATION OF ANEURYSM. THERE WAS A 5¿10-MINUTE DELAY IN THE PROCEDURE BUT IT WAS NOT CLINICALLY SIGNIFICANT PER THE TREATING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262699 DELTAXSFT10 2MM X 6CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL DLX100206 30399407 10886704077336

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention DELTAXSFT10 2MM X 3CM| SL-10® 45° MICROCATHETER (STRYKER)