BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTILENE 6/0 (0,7)75CM 2XPRC13B CV2 RCP

    MDR report key: 24685675 · Received March 25, 2026

    Report

    Report Number
    3003639970-2026-00368
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    March 5, 2026
    Report Date
    April 14, 2026
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAW
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. UNDER PMA/510(K) NUMBER: K133890. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH OPTILENE SUTURE. THE CLIENT REPORTED THAT OPTILENE FRAYS OVER A LENGTH OF APPROXIMATELY 5 CM AND SUBSEQUENTLY TEARS WHEN THE KNOT IS TIED IN THE MATERIAL. THE CUSTOMER OBSERVED THE SAME PHENOMENON WITH THREE CONSECUTIVE THREADS TAKEN FROM THE SAME PACKAGE. THE MATERIAL WAS USED FOR A VEIN-AORTA ANASTOMOSIS WITHOUT CALCIFICATION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532148 OPTILENE 6/0 (0,7)75CM 2XPRC13B CV2 RCP CARDIAC SUTURE GAW B. BRAUN SURGICAL, S.A. C3097701 625371

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown