BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTH® CLAMPS

    MDR report key: 22681317 · Received July 31, 2025

    Report

    Report Number
    2027111-2025-00665
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Report Date
    October 30, 2025
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    DXC
    UDI-DI
    00607915114237
    PMA / PMN Number
    K950492
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION, AND THE LOT NUMBER WAS NOT PROVIDED. AS THE EVENT UNIT WAS NOT RETURNED, APPLIED MEDICAL IS UNABLE TO DETERMINE IF THE EVENT UNIT EXHIBITED ANY NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IN THE ABSENCE OF THE EVENT UNIT, IT IS DIFFICULT TO DETERMINE IF THE REPORTED EVENT WAS CAUSED BY A MANUFACTURING NON-CONFORMANCE OR CIRCUMSTANTIAL FACTORS AT THE TIME OF USE. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND IS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT. APPLIED MEDICAL HAS PERFORMED A HISTORICAL TREND ANALYSIS AND REVIEW OF PRODUCTION RECORDS AND NO RELEVANT DOCUMENTATIONS WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT IS NOT ANTICIPATED TO RETURN TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: CARDIO THORACIC PROCEDURE. EVENT DESCRIPTION: IT WAS REPORTED BY THE CONSULTANT SURGEON THAT THE CLAMP WAS SLIPPING OF THE AORTA DURING THE CASE. CASE COMPLETED WITH ANOTHER CLAMP. CASE COMPLETED AND NO INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT. INTERVENTION: CASE COMPLETED WITH ANOTHER CLAMP. PATIENT STATUS: CASE COMPLETED.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: CARDIO THORACIC PROCEDURE. EVENT DESCRIPTION: IT WAS REPORTED BY THE CONSULTANT SURGEON THAT THE CLAMP WAS SLIPPING OF THE AORTA DURING THE CASE. CASE COMPLETED WITH ANOTHER CLAMP. CASE COMPLETED AND NO INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT. INTERVENTION: CASE COMPLETED WITH ANOTHER CLAMP. PATIENT STATUS: CASE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198468 STEALTH® CLAMPS CLAMP, VASCULAR DXC APPLIED MEDICAL RESOURCES A3220 NI 00607915114237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown