BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE BLUE 1.5M 90CM W/NDL

    MDR report key: 21226423 · Received January 23, 2025

    Report

    Report Number
    2210968-2025-00893
    Event Type
    Malfunction
    Date Received
    January 23, 2025
    Date of Event
    February 19, 2024
    Report Date
    January 23, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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 ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. D4: UDI: (01)GTIN IS UNAVAILABLE THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WERE THERE ANY PATIENT CONSEQUENCES? WHEN DID THE SUTURE BREAK (IN THE PACKAGE, DURING REMOVAL FROM THE PACKAGE, DURING HANDLING PRIOR TO USING ON THE PATIENT, OR DURING USE ON THE PATIENT)? PLEASE REFER TO THE EVENT DESCRIPTION, OTHER INFORMATION REQUESTED IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL AORTIC ARCH ARTIFICIAL VESSEL REPLACEMENT AND STENT ELEPHANT TRUNK SURGERY (SUN'S SURGERY) ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE OPERATION, THE SUTURE BROKE. AS THE LARGE BLOOD VESSELS WERE SUTURED CONTINUOUSLY, THE SUTURE WAS REMOVED AND REPLACED WITH A NEW ONE FOR RE SUTURING. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721796 PROLENE BLUE 1.5M 90CM W/NDL SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. THBHRM

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male