BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAFILL18 6MM X 25CM

    MDR report key: 8588472 · Received May 7, 2019

    Report

    Report Number
    3008114965-2019-01001
    Event Type
    Malfunction
    Date Received
    May 7, 2019
    Date of Event
    April 17, 2019
    Report Date
    April 17, 2019
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704076933
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON (B)(6) 2019. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE MAJOR AORTO-PULMONARY COLLATERAL ARTERY (MAPCA) COIL EMBOLIZATION PROCEDURE TARGETING THE LESION AT THE COLLATERAL CIRCULATION COMING FROM THE RIGHT INTERNAL MAMMARY ARTERY, WHEN THE 6MM X 25CM DELTAFILL 18 COIL (DLF180625 / L11591) WAS APPROACHING THE TARGET LESION, RESISTANCE WAS FELT, AND THE PHYSICIAN PUSHED AND WITHDRAWN THE COIL WITH THE CONCOMITANT LIGHTHOUSE® MICROCATHETER (PIOLAX MEDICAL); THEN IT WAS CONFIRMED THAT THE COIL BECAME UNRAVELED. IT WAS REPORTED THAT A CONTINUOUS FLUSH HAD NOT BEEN MAINTAINED THROUGH THE MICROCATHETER, BUT PRIOR TO THIS COIL, THERE WERE OTHER COILS THAT WERE ABLE TO GO THROUGH THE MICROCATHETER WITHOUT ANY RESISTANCE. THE PROWLER SELECT PLUS LPES MICROCATHETER WAS USED AND THE PROCEDURE WAS COMPLETED WITH A NEW COIL. THE PHYSICIAN COMMENTED THAT THE TORTUOSITY OF THE PATIENT¿S VESSELS WAS SEVERE. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION, NO PROCEDURAL DELAY AND NO ADDITIONAL INTERVENTION REQUIRED. ALL THE DEVICES WERE HANDLED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE COMPLAINT DEVICE WAS DISCARDED DUE TO INFECTIOUS DISEASES. BASED ON COMPLAINT INFORMATION, THE DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L11591) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NON-CONFORMANCES 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. WITH THE INFORMATION PROVIDED AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT 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. THE EXACT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS POSSIBLE THAT CIRCUMSTANCES OF THE PROCEDURE AND/OR DEVICE MANIPULATION/INTERACTION MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. ADDITIONAL INFORMATION REPORTED THAT A CONTINUOUS FLUSH HAD NOT BEEN MAINTAINED THROUGH THE MICROCATHETER, THE INSTRUCTION FOR USE (IFU) STATES THAT CONTINUOUS INFUSION OF AN APPROPRIATE FLUSH SOLUTION IS REQUIRED FOR OPTIMAL PERFORMANCE, AND ALSO INDICATES THAT THE FLUSH SHOULD BE VERIFIED IN THE EVENT OF RESISTANCE. INSUFFICIENT FLUSH ALLOWS BLOOD TO BACK-FLOW INTO THE MICROCATHETER, WHICH CAN CAUSE RESISTANCE. THE REPORTED EVENT WAS RELATED TO RESISTANCE, THEN THE COIL BECAME UNRAVELED WHEN IT WAS WITHDRAWN WITH THE MICROCATHETER. THE INSUFFICIENT FLUSH LIKELY CONTRIBUTED TO THE RESISTANCE ISSUE REPORTED AND RESULTED IN THE COIL BECOMING UNRAVELED. 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. INITIAL REPORTER PHONE: (B)(6). 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

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. PROCODE IS KRD/HCG. INITIAL REPORTER INFORMATION SUCH AS THE NAME, PHONE AND EMAIL ADDRESS ARE NOT AVAILABLE. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L11591) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NON-CONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. 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. 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 MAJOR AORTO-PULMONARY COLLATERAL ARTERY (MAPCA) COIL EMBOLIZATION PROCEDURE TARGETING THE LESION AT THE COLLATERAL CIRCULATION COMING FROM THE RIGHT INTERNAL MAMMARY ARTERY, WHEN THE 6MM X 25CM DELTAFILL 18 COIL (DLF180625 / L11591) WAS APPROACHING THE TARGET LESION, RESISTANCE WAS FELT, AND THE PHYSICIAN PUSHED AND WITHDRAWN THE COIL. THEN IT WAS CONFIRMED THAT THE COIL BECAME UNRAVELED. THE COIL WAS THEN REMOVED FROM THE PATIENT¿S BODY TOGETHER WITH THE CONCOMITANT LIGHTHOUSE® MICROCATHETER (PIOLAX MEDICAL). THE PROWLER SELECT PLUS LPES MICROCATHETER WAS USED AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN COMMENTED THAT THE TORTUOSITY OF THE PATIENT¿S VESSELS WAS SEVERE. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION. ALL THE DEVICES WERE HANDLED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE COMPLAINT DEVICE WAS DISCARDED DUE TO INFECTIOUS DISEASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382625 DELTAFILL18 6MM X 25CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL L11591 10886704076933

    Patients

    Seq Age Sex Outcome Treatment
    1