BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEREPAKTM

    MDR report key: 21027287 · Received December 27, 2024

    Report

    Report Number
    3008114965-2024-01242
    Event Type
    Malfunction
    Date Received
    December 27, 2024
    Date of Event
    December 12, 2024
    Report Date
    December 27, 2024
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704084600
    PMA / PMN Number
    K220040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, SEX, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION D.2B: PROCODE IS KRD/HCG. SECTION E.1: THE INITIAL REPORTER EMAIL ADDRESS WAS NOT AVAILABLE / REPORTED. SECTION D.2B: PROCODE IS KRD/HCG. SECTION D.4: THE EXPIRATION DATE OF THE DEVICE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. THE FULL UDI IS NOT AVAILABLE WITHOUT THE EXPIRATION DATE. SECTION E.1: THE INITIAL REPORTER EMAIL ADDRESS WAS NOT AVAILABLE / REPORTED. SECTION H.4: THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. THE FULL UDI IS NOT AVAILABLE WITHOUT THE MANUFACTURE DATE. BASED ON COMPLAINT INFORMATION, THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. THE DEVICE LOT NUMBER WAS NOT AVAILABLE. THE MANUFACTURING DOCUMENTATION REVIEW COULD NOT BE PERFORMED WITHOUT THE LOT NUMBER. 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 AVAILABLE AND WITHOUT THE COMPLAINT PRODUCT AVAILABLE TO BE RETURNED FOR ANALYSIS, THE REPORTED PRODUCT ISSUE DOCUMENTED IN THE COMPLAINT CANNOT BE CONFIRMED THROUGH FUNCTIONAL EVALUATION AND ANALYSIS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; THEREFORE, MANUFACTURING DOCUMENTATION REVIEW WAS NOT PERFORMED. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE COMPLAINT SAMPLE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION / INTERACTION 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 LATER. 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY JOHNSON & JOHNSON MEDTECH, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, JOHNSON & JOHNSON MEDTECH, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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 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 · 0

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION OF THE MIDDLE MENINGEAL ARTERY (MMA) WITH MILD TORTUOSITY NOTED IN THE LATERAL EXTERNAL CAROTID ARTERY (LECA) AND THE LEFT MMA, A 2MM X 6CM CEREPAK HELIFORM XTRASOFT XL (XHE120206 / 31393529) WAS USED THROUGH A PLATO® 17 MICROCATHETER (SCIENTIA VASCULAR). THE DETACHMENT HANDLE (MDH1 / LOT# UNKNOWN) WAS USED FOR THE FIRST TWO DETACHMENT ATTEMPTS. AFTER THE FAILED DETACHMENT ATTEMPTS WITH THE HANDLE, THE MANUAL BREAK METHOD WAS USED, WHICH ALSO FAILED. THE COIL WAS REMOVED, AND ANOTHER COIL OF THE SAME SIZE WAS USED WITH SUCCESS. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT NOR ANY DELAY IN THE PROCEDURE. THE LEFT MMA WAS SUCCESSFULLY EMBOLIZED WITH TWO MORE CEREPAK COILS. ON 27-DEC-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION THE LOT NUMBER OF THE DETACHMENT HANDLE IS NOT KNOWN. WHEN THE COIL WAS REMOVED FROM THE PATIENT, IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM. ¿THE COIL WAS INSPECTED ON THE BACK TABLE AND THERE WAS NO VISIBLE DAMAGE TO THE DELIVERY SYSTEM THAT COULD HAVE CONTRIBUTED TO THE DETACHMENT FAILURE.¿ THE COIL WAS NOT STRETCHED. THERE WAS NO EVIDENCE OF BLOOD FLOW INTERRUPTION AS A RESULT OF THE REPORTED ISSUE. THE REPLACEMENT COIL WAS ANOTHER 2MM X 6MM HELIFORM COIL AND IT WAS USED WITH THE SAME ORIGINAL DETACHMENT HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2498351 CEREPAKTM CEREPAK DETACHABLE COIL SYSTEM KRD MEDOS INTERNATIONAL SARL 10886704084600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown HELIFORM XSFT XL 2MM X 6 CM| PLATO® 17 MICROCATHETER (SCIENTIA VASCULAR)