BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALVE XS DE'BAKEY FCPS STR.WIDE 230/370

    MDR report key: 22184587 · Received June 11, 2025

    Report

    Report Number
    9610612-2025-00108
    Event Type
    Malfunction
    Date Received
    June 11, 2025
    Date of Event
    February 21, 2025
    Report Date
    June 12, 2025
    Manufacturer
    AESCULAP AG
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B5 - DESCRIPTION UPDATED. THE COMPLAINED DEVICE WAS CONFIRMED TO BE A NON-AAG PRODUCT. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED / DEEMED NOT REPORTABLE FOR THE FOLLOWING REASON: NO SERIOUS PUBLIC HEALTH THREAT / FALSIFIED DEVICE NO SERIOUS ADVERSE EVENT.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    UPDATE: IT WAS CONFIRMED THAT THERE WAS NOT AN ISSUE WITH THE DE'BAKEY FORCEPS, BUT RATHER THE NON-AAG RETRACTOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FC289R - VALVE XS DE'BAKEY FCPS STR.WIDE 230/370. ACCORDING TO THE COMPLAINT DESCRIPTION, THE MIDDLE BEAD BROKE AND THE FIXATOR FELL OFF; AND THEN THE LEFT ATRIAL RETRACTOR COULD NOT BE FASTENED. ANOTHER DEVICE WAS IMMEDIATELY AVAILABLE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS OCCURRED DURING VIDEO-ASSISTED THORACOSCOPIC SURGERY (VAT) MITRAL VALVULOPLASTY, LEFT ATRIAL APPENDAGE SUTURE AND RADIOFREQUENCY ABLATION FOR ATRIAL FIBRILLATION. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - MALFUNCTION (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS MALFUNCTION WAS BASED ON REVIEW OF THE APPLICABLE RISK ANALYSIS. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE MALFUNCTION IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103247 VALVE XS DE'BAKEY FCPS STR.WIDE 230/370 GENERAL SURGICAL INSTRUMENTS HTD AESCULAP AG FC289R

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown