BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRUSFRAME18 12MM X 40CM

    MDR report key: 8156598 · Received December 12, 2018

    Report

    Report Number
    3008114965-2018-00834
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    November 30, 2018
    Report Date
    December 3, 2018
    Manufacturer
    REFER TO SECTION H10
    Product Code
    KRD
    UDI-DI
    10886704078098
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE HISTORY RECORD REVIEW. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT 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. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. PLEASE NOTE THAT DEVICE CODE "OFF-LABEL USE" (B)(4) WAS SELECTED AS THE PRODUCT INSTRUCTIONS FOR USE (IFU) STATES THAT THE MICROCOIL DELIVERY SYSTEM IS INTENDED FOR ENDOVASCULAR EMBOLIZATION OF INTRACRANIAL ANEURYSMS. THE DEVICE WAS USED IN AN ENDOVASCULAR ANEURYSM REPAIR. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). CORRECTED SECTIONS: H6 (CONCLUSION): REMOVE "CAUSE TRACED TO INTENTIONAL OFF-LABEL, UNAPPROVED, OR CONTRAINDICATED USE" (24). SECTION B5: ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT THE NEED FOR ADDITIONAL INTERVENTION. THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY. AN ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF UNDUE FORCE. IT IS NOT KNOWN IF THE USER CHANGED THE CONNECTING CABLE AND/OR DETACHMENT CONTROL BOX (DCB) AT ANY POINT DURING THE REPORTED EVENT. IT IS ALSO UNKNOWN IF THE SAME CONNECTING CABLE AND DCB WERE USED TO DETACH SUBSEQUENT COILS. THE USER DID NOT APPLY EXCESSIVE FORCE AT ANY TIME. IT WAS NOT REPORTED HOW LONG THE EVENT WAS DELAYED DUE TO THE EVENT; HOWEVER, THE DELAY IN PROCEDURE WAS NOT CONSIDERED CLINICALLY SIGNIFICANT. NO FURTHER INFORMATION COULD BE OBTAINED. SECTION E1 - INITIAL REPORTER PHONE: (B)(6). [COMPLAINT CONCLUSION] AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ENDOVASCULAR ANEURYSM REPAIR (EVAR), THE 12MM X 40CM MICRUSFRAME18 (MFR181240/L11484) FAILED TO DETACH ALTHOUGH THE ¿DETACH¿ BUTTON WAS PRESSED. THE COIL WAS REPLACED WITH A COIL FROM THE SAME PRODUCT CODE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT THE NEED FOR ADDITIONAL INTERVENTION. IT WAS NOT REPORTED HOW LONG THE EVENT WAS DELAYED DUE TO THE EVENT; HOWEVER, THE DELAY IN PROCEDURE WAS NOT CONSIDERED CLINICALLY SIGNIFICANT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY. AN ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. NO VISIBLE PRODUCT DEFECT/DAMAGE WAS NOTED PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF UNDUE FORCE. IT IS UNKNOWN IF THE USER CHANGED THE CONNECTING CABLE AND/OR DETACHMENT CONTROL BOX (DCB) AT ANY POINT DURING THE REPORTED EVENT. IT IS ALSO UNKNOWN IF THE SAME CONNECTING CABLE AND DCB WERE USED TO DETACH SUBSEQUENT COILS. THE USER DID NOT APPLY EXCESSIVE FORCE AT ANY TIME. AN ENPOWER CONTROL CABLE AND ENPOWER DCB2000500 (DCB2) DETACHMENT CONTROL BOX WERE USED IN THE CASE. NO FURTHER INFORMATION COULD BE OBTAINED. THE 12MM X 40CM MICRUSFRAME18 WAS NOT RETURNED FOR EVALUATION. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT 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. WITH THE LIMITED INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE CUSTOMER REPORT THAT THE COIL FAILED TO DETACH COULD NOT BE CONFIRMED. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. FAILURE TO DETACH IS A KNOWN POTENTIAL PRODUCT ISSUE ASSOCIATED WITH THE USE OF THE DEVICE. THE IFU CONTAINS SEVERAL CAUTIONS RELATING TO THIS SITUATION, INCLUDING INSTRUCTIONS FOR TROUBLESHOOTING THE SITUATION SHOULD IT BE ENCOUNTERED DURING USE. PER THE IFU: ¿VERIFY THAT THE MICROCOIL DELIVERY SYSTEM IS FULLY CONNECTED, AND NO FAULTS ARE INDICTED ON THE DCB. IF A FAULT EXISTS, RESEAT ALL CONNECTIONS BETWEEN THE DPU, THE DCB, AND THE CONNECTING CABLE. IF A FAULT STILL PERSISTS, REPLACE THE CONNECTING CABLE. IF THIS DOES NOT CORRECT THE ERROR, REPLACE THE DCB. IF THE MICROCOIL DELIVERY SYSTEM STILL CONTINUES TO HAVE A FAULT, RETRIEVE THE MICROCOIL, AND REPLACE WITH A NEW MICROCOIL SYSTEM. IF THE SYSTEM IS FREE OF FAULTS, DEPRESS THE DETACH BUTTON ON THE BLUE ENPOWER DCB, THE BLACK DCB OR THE ENPOWER CONTROL CABLE. THE DETACH CYCLE LIGHT NEXT TO THE BUTTON WILL ILLUMINATE AND AN INTERMITTENT TONE WILL SOUND FOR THE DURATION OF THE DETACHMENT CYCLE. IF THE LIGHT AND AUDIBLE TONE DO NOT ACTIVATE, REPLACE THE DCB.¿ ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE MINIMAL INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE COMPLAINT DEVICE; HOWEVER, IT IS POSSIBLE THAT PROCEDURAL AND HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. 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. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT AGE/DATE OF BIRTH, GENDER, WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT PROVIDED. PROCODE: KRD/HCG. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). CONCOMITANT MEDICAL PRODUCTS DUE TO CHARACTER LIMITATION: ENPOWER CONTROL CABLE, ENPOWER DCB2000500 (DCB2). INITIAL REPORTER - THE CUSTOMER CONTACT INFORMATION, INCLUDING NAME, OCCUPATION, PHONE, FAX, AND E-MAIL ADDRESS, WAS NOT REPORTED. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)) THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ENDOVASCULAR ANEURYSM REPAIR (EVAR), THE 12MM X 40CM MICRUSFRAME18 (MFR181240/L11484) FAILED TO DETACH ALTHOUGH THE ¿DETACH¿ BUTTON WAS PRESSED. THE COIL WAS REPLACED WITH A COIL FROM THE SAME PRODUCT CODE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR DELAY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DEFECT/DAMAGE WAS NOTED PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. AN ENPOWER CONTROL CABLE AND ENPOWER DCB2000500 (DCB2) DETACHMENT CONTROL BOX WERE USED IN THE CASE. THE PRODUCT WAS DISCARDED AND IS THUS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994795 MICRUSFRAME18 12MM X 40CM NEUROVASCULAR EMBOLIZATION DEVICE KRD REFER TO SECTION H10 L11484 10886704078098

    Patients

    Seq Age Sex Outcome Treatment
    1