BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAFILL18 24MM X 60CM

    MDR report key: 8920960 · Received August 22, 2019

    Report

    Report Number
    3008114965-2019-01151
    Event Type
    Malfunction
    Date Received
    August 22, 2019
    Date of Event
    August 8, 2019
    Report Date
    August 8, 2019
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077183
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION B5: ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO DAMAGE CONFIRMED ON THE DEVICES PRIOR TO USE. THE DEVICES WERE USED AND PREPPED AS PER THE INSTRUCTIONS FOR USE. ADEQUATE FLUSH HAD BEEN MAINTAINED THROUGH THE DEVICES. THE CONCOMITANT DEVICES FUNCTIONED AS EXPECTED. SECTION E1 ¿ INITIAL REPORTER PHONE: (B)(6). THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). COMPLAINT CONCLUSION: AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION OF A DISSECTING ANEURYSM, 24MM X 60CM DELTAFILL18 COIL, WAS INSERTED INTO THE TARGET LESION. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL AND PRESSED THE DETACHMENT BUTTON AFTER A AB ENPOWER CONTROL CABLE (ECB00018200, L13631) WAS CONNECTED. THE COIL COULD NOT BE DETACHED EVEN THOUGH THE SOUND WAS HEARD. THE PHYSICIAN ATTEMPTED SEVERAL TIMES, BUT THE SAME ISSUE CONTINUED. THEREFORE, THE COMPLAINT COIL WAS REPLACED WITH A COMPETITIVE PRODUCT AND THE PROCEDURE WAS CONTINUED. SINCE THE COIL WAS REPLACED BEFORE THE PHYSICIAN IDENTIFY THE CAUSE OF THE ISSUE, IT IS UNKNOWN WHETHER THE ISSUE WAS WITH THE COIL OR THE CABLE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO DAMAGE CONFIRMED ON THE DEVICES PRIOR TO USE. THE DEVICES WERE USED AND PREPPED AS PER THE INSTRUCTIONS FOR USE. ADEQUATE FLUSH HAD BEEN MAINTAINED THROUGH THE DEVICES. THE CONCOMITANT DEVICES FUNCTIONED AS EXPECTED. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE. ONE NON-STERILE UNIT DELTAFILL18 24MM X 60CM WAS RECEIVED INSIDE OF A POUCH. THE HUB WAS INSPECTED, AND NO DAMAGES WAS NOTED ON IT. THE DPU WAS INSPECTED AND IT WAS FOUND IN GOOD CONDITIONS. THE INTRODUCER WAS INSPECTED, AND NO DAMAGES WAS NOTED ON IT. THE RE-SHEATHING TOOL WAS INSPECTED, AND IT WAS FOUND IN GOOD CONDITIONS. ALSO, THE MARKER BAND WAS FOUND AT 95CM FROM HUB, AND IT WAS FOUND WITHIN SPECIFICATION. THE V-NOTCH WAS INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE NOTED ON IT. THE RH WAS INSPECTED UNDER MICROSCOPE AND IT WAS FOUND IN GOOD CONDITIONS. THE EMBOLIC COIL WAS INSPECTED UNDER MICROSCOPE AND NO DAMAGES WAS NOTED ON IT. A LAB SAMPLE ENPOWER CONTROL CABLE WAS CONNECTED TO DELTAFILL18 24MM X 60CM AND THEM WERE CONNECTED TO DETACHMENT CONTROL BOX AND THE POWER WAS TURNED ON. THE SYSTEM READY LIGHT ILLUMINATED. A DETACHMENT CYCLE WAS INITIATED WHEN THE DETACH BUTTON WAS PRESSED. AFTER THAT THE EMBOLIC COIL WAS DETACHED FROM THE DEVICE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE L11298 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED THE COMPLAINT REPORTED BY THE CUSTOMER ¿COIL - FAILURE TO DETACH¿ WAS NOT CONFIRM DUE ON THE FUNCTIONAL TEST THE EMBOLIC COIL WAS DETACHED FROM THE DEVICE SATISFACTORILY. NEITHER THE ANALYSIS NOR THE MRE SUGGEST THAT THE FAILURE REPORTED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS. BASED ON THE INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE COMPLAINT DEVICES; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION / INTERACTION, ANEURYSM SIZE AND VESSEL CHARACTERISTICS, DEVICE SELECTION, AND THE CONCOMITANT MICROCATHETER, MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE WITH THE COIL FAILING TO DETACH. FAILURE TO DETACH IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THIS DEVICE. THE INSTRUCTIONS FOR USE (IFU) CONTAINS SEVERAL PRECAUTIONS RELATED TO THIS ISSUE AND INCLUDES INSTRUCTIONS FOR TROUBLESHOOTING THE SITUATION SHOULD IT BE ENCOUNTERED DURING USE. 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. INITIAL REPORTER: THE CUSTOMER CONTACT INFORMATION, INCLUDING NAME, OCCUPATION, PHONE, FAX, AND E-MAIL ADDRESS, WAS NOT REPORTED. MANUFACTURING SITE NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. (B)(4). THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. 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.

    Description of Event or Problem · 1

    AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION OF A DISSECTING ANEURYSM, 24MM X 60CM DELTAFILL18 COIL, WAS INSERTED INTO THE TARGET LESION. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL AND PRESSED THE DETACHMENT BUTTON AFTER A AB ENPOWER CONTROL CABLE (ECB00018200, L13631) WAS CONNECTED. THE COIL COULD NOT BE DETACHED EVEN THOUGH THE SOUND WAS HEARD. THE PHYSICIAN ATTEMPTED SEVERAL TIMES, BUT THE SAME ISSUE CONTINUED. THEREFORE, THE COMPLAINT COIL WAS REPLACED WITH A COMPETITIVE PRODUCT AND THE PROCEDURE WAS CONTINUED. SINCE THE COIL WAS REPLACED BEFORE THE PHYSICIAN IDENTIFY THE CAUSE OF THE ISSUE, IT IS UNKNOWN WHETHER THE ISSUE WAS WITH THE COIL OR THE CABLE. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716244 DELTAFILL18 24MM X 60CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL L14198 10886704077183

    Patients

    Seq Age Sex Outcome Treatment
    1 ENPOWER CONTROL CABLE