BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRUSFRAME18 12MM X 40CM

    MDR report key: 7319840 · Received March 7, 2018

    Report

    Report Number
    3008114965-2018-00554
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    February 13, 2018
    Report Date
    February 13, 2018
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704078098
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE COIL DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE COIL WAS STILL ATTACHED. PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. COMPLAINT CONCLUSION: AS REPORTED BY AN AFFILIATE, DURING A THORACIC AORTAL STENT-GRAFTING AND THE COIL EMBOLIZATION AT THE LEFT SUBCLAVIAN ARTERY, A MICRISFRAM18S (MFR181240, S12858) WAS INSERTED IN THE LEFT SUBCLAVIAN ARTERY AND THE PHYSICIAN ATTEMPTED TO DETACH THE COIL. HOWEVER, THE GREEN READY LIGHT WAS NOT ON AND IT COULD NOT DETACH THE COIL. THE MICRUSFRAME WAS NOT FLUSHED TO IMPROVE. THE COIL DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE COIL WAS STILL ATTACHED. ANOTHER PRODUCT WITH FROM ANOTHER LOT WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY OR COMPLICATIONS REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO AND AFTER THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICRO CATHETER. THE PATIENT¿S VESSEL WAS NOT TORTUROUS AND HEAVILY CALCIFIED. A MICRO CATHETER (PROGREAT S, TERUMO), A Y CONNECTOR (OKAY, GOODMAN) AND AN EMPOWER CONTROL CABLE WERE ALSO USED FOR THIS PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. THE MICRUSFRAME18 PRODUCT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. WITHOUT THE DEVICE RETURNED FOR INVESTIGATION, THE REPORTED EVENT OF FAILURE TO DETACH COULD NOT BE CONFIRMED. HOWEVER, BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THERE ARE VESSEL CHARACTERISTICS (CALCIFICATION) THAT MAY HAVE CONTRIBUTED TO THE EVENT REPORTED. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. 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

    (B)(4). THE MICRUSFRAME18 PRODUCT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. (B)(4). PHYSICAL MANUFACTURER: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. (B)(4). THE NAME OF THE INITIAL REPORTER IS UNKNOWN. THE MANUFACTURER REPRESENTATIVE WAS PROVIDED AS THE INITIAL REPORTER NAME. INFORMATION REGARDING PATIENT AGE, GENDER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. 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

    AS REPORTED BY AN AFFILIATE, DURING A THORACIC AORTAL STENT-GRAFTING AND THE COIL EMBOLIZATION AT THE LEFT SUBCLAVIAN ARTERY, A MICRISFRAM18S (MFR181240, S12858) WAS INSERTED IN THE LEFT SUBCLAVIAN ARTERY AND THE PHYSICIAN ATTEMPTED TO DETACHED THE COIL. HOWEVER, THE GREEN READY LIGHT WAS NOT ON AND IT COULD NOT DETACH THE COIL. THE MICRUSFRAME WAS NOT FLUSHED TO IMPROVE. THEREFORE, IT WAS REPLACED WITH ANOTHER PRODUCT WITH ANOTHER LOT NUMBER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY OR COMPLICATIONS REPORTED. THE PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO AND AFTER THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICRO CATHETER. THE PATIENT¿S VESSEL WAS NOT TORTUROUS AND HEAVILY CALCIFIED. A MICRO CATHETER (PROGREAT S, TERUMO), A Y CONNECTOR (OKAY, GOODMAN) AND AN EMPOWER CONTROL CABLE WERE ALSO USED FOR THIS PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162811 MICRUSFRAME18 12MM X 40CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL S12858 10886704078098

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR