BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRUSFRAME10 6MM X 26CM

    MDR report key: 10270205 · Received July 14, 2020

    Report

    Report Number
    3008114965-2020-00279
    Event Type
    Injury
    Date Received
    July 14, 2020
    Date of Event
    June 23, 2020
    Report Date
    June 23, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077862
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). SECTION B5: ADDITIONAL EVENT INFORMATION INDICATED THAT THERE WAS AN ADEQUATE FLUSH MAINTAINED THROUGH THE DEVICES AND EXCESSIVE FORCE HAD NOT BEEN APPLIED TO THE DEVICE. THE LENGTH OF TIME THAT THE PROCEDURE WAS DELAYED DUE TO THE EVENT WAS NOT REPORTED; HOWEVER, THE PHYSICIAN DID NOT FEEL THAT THE PROLONGATION OF PROCEDURE WAS CLINICALLY SIGNIFICANT. IT IS UNKNOWN IF A PRE-DEPLOYMENT ELECTRICAL TEST WAS PERFORMED OR IF THE CONTROL CABLE (S) AND DETACHMENT CONTROL BOX UNIT (S) WERE RE-CHALLENGED AND SUCCESSFULLY TO DETACH SUBSEQUENT COILS. NO FURTHER INFORMATION COULD BE OBTAINED. SECTION E1. INITIAL REPORTER PHONE: (B)(6). COMPLAINT CONCLUSION: A REPORT FROM THE FIELD INDICATED THAT DURING A COIL EMBOLIZATION OF A BASILAR TIP ANEURYSM, A 6MM X 26CM MICRUSFRAME10 (MFR100626/UNKNOWN LOT #) COIL WAS ATTEMPTED TO BE DETACHED USING THE ENPOWER CONTROL CABLE (ECB00018200/K10545) BUT THE COIL FAILED TO DETACH. THEREFORE, THE DETACHMENT CONTROL BOX (UNKNOWN PRODUCT CODE & LOT #) WAS REPLACED BUT THE SAME ISSUE CONTINUED. THE ENPOWER CONTROL CABLE WAS THEN REPLACED BUT THE COIL WOULD NOT DETACH. THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL FROM THE PATIENT, BUT THE COIL UNINTENDEDLY DETACHED IN THE MICROCATHETER. A GUIDEWIRE WAS USED TO PUSH THE COIL INTO THE ANEURYSM AND THE COIL WAS IMPLANTED. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 28-JUL-2020 INDICATED THAT THERE WAS AN ADEQUATE FLUSH MAINTAINED THROUGH THE DEVICES AND EXCESSIVE FORCE HAD NOT BEEN APPLIED TO THE DEVICE. THE LENGTH OF TIME THAT THE PROCEDURE WAS DELAYED DUE TO THE EVENT WAS NOT REPORTED; HOWEVER, THE PHYSICIAN DID NOT FEEL THAT THE PROLONGATION OF PROCEDURE WAS CLINICALLY SIGNIFICANT. IT IS UNKNOWN IF A PRE-DEPLOYMENT ELECTRICAL TEST WAS PERFORMED OR IF THE CONTROL CABLE (S) AND DETACHMENT CONTROL BOX UNIT (S) WERE RE-CHALLENGED AND SUCCESSFULLY TO DETACH SUBSEQUENT COILS. NO FURTHER INFORMATION COULD BE OBTAINED. THE DEVICE REMAINS IMPLANTED; THEREFORE, IT IS NOT AVAILABLE FOR ANALYSIS. THE MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE PERFORMED DUE TO THE LOT NUMBER WAS NOT PROVIDED. FAILURE TO DETACH AND UNINTENDED DETACHMENT REQUIRING ADDITIONAL INTERVENTION ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF MICRUSFRAME COILS IN COIL EMBOLIZATION PROCEDURES. FACTORS THAT CAN CONTRIBUTE TO DETACHMENT ISSUES INCLUDE FAILURE TO CONFIRM SECURE CONNECTION OF THE CABLE TO THE DPU AND 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. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW AND WITHOUT THE RETURN OF THE ASSOCIATED DEVICES; HOWEVER, IT IS POSSIBLE THAT CIRCUMSTANCES OF THE PROCEDURE MAY HAVE CONTRIBUTED. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. PROCODE: KRD/HCG. LOT: THE LOT NUMBER IS NOT AVAILABLE. INITIAL REPORTER: THE CUSTOMER CONTACT INFORMATION, INCLUDING NAME, OCCUPATION, PHONE, FAX, AND E-MAIL ADDRESS, WAS NOT REPORTED. (B)(4). 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 COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THE DEVICE WAS IMPLANTED, THEREFORE, NO PRODUCT INVESTIGATION CAN BE PERFORMED. THE MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE PERFORMED DUE TO THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    A REPORT FROM THE FIELD INDICATED THAT DURING A COIL EMBOLIZATION OF A BASILAR TIP ANEURYSM, A 6MM X 26CM MICRUSFRAME10 (MFR100626/UNKNOWN LOT #) COIL WAS ATTEMPTED TO BE DETACHED USING THE ENPOWER CONTROL CABLE (ECB00018200/K10545) BUT THE COIL FAILED TO DETACH. THEREFORE, THE DETACHMENT CONTROL BOX (UNKNOWN PRODUCT CODE & LOT #) WAS REPLACED BUT THE SAME ISSUE CONTINUED. THE ENPOWER CONTROL CABLE WAS THEN REPLACED BUT THE COIL WOULD NOT DETACH. THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL FROM THE PATIENT, BUT THE COIL UNINTENDEDLY DETACHED IN THE MICROCATHETER. A GUIDEWIRE WAS USED TO PUSH THE COIL INTO THE ANEURYSM AND THE COIL WAS IMPLANTED. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF COMPLAINT INITIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736166 MICRUSFRAME10 6MM X 26CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL MFR100626 10886704077862

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DETACHMENT CONTROL BOX.| ENPOWER CONTROL CABLE.| UNSPECIFIED GUIDEWIRE.| UNSPECIFIED GUIDEWIRE.| UNSPECIFIED MICROCATHETER.