BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTILENE 6/0 (0,7) 75CM 2XDR10B CV2 RCP

    MDR report key: 24647402 · Received March 20, 2026

    Report

    Report Number
    3003639970-2026-00361
    Event Type
    Injury
    Date Received
    March 20, 2026
    Date of Event
    February 22, 2026
    Report Date
    March 20, 2026
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAW
    PMA / PMN Number
    SEE H11
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    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., K133890. SUMMARY OF INVESTIGATION: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE HAVE RECEIVED 4 DIFFERENT CASES AT THE SAME TIME OF THE SAME CODE-BATCH AND REGARDING A SIMILAR ISSUE. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE NOT RECEIVED ANY SAMPLE FOR ANALYSIS, ONLY TWO PICTURES SHOWING AN OPEN AND MANIPULATED SAMPLE, IN WHICH A SECTION OF THE THREAD SHOWS FIBER SPLITTING. HOWEVER, WITHOUT ANY CLOSED SAMPLE, WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. BATCH MANUFACTURING RECORD: REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. CONCLUSION ROOT CAUSE ANALYSIS: IT HAS NOT BEEN POSSIBLE TO DETERMINE THE ROOT CAUSE AS NO SAMPLES HAVE BEEN RECEIVED FOR ANALYSIS, ONLY PICTURES. FINAL CONCLUSION: IN SPITE OF RECEIVING PICTURES SHOWING A DEFECTIVE SAMPLE, WITHOUT CLOSED SAMPLES A SUITABLE ANALYSIS CANNOT BE PERFORMED, AND THE CASE IS CONSIDERED NOT CONFIRMED. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY CLOSED SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYSE IT. CORRECTIVE MEASURES: ACTIONS ON DISTRIBUTED PRODUCT OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH OPTILENE SUTURE. THE CLIENT REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2026. A CORONARY ARTERY BYPASS GRAFTING (MAMMARY CORONARY ARTERY BYPASS GRAFTING TO THE ANTERIOR DESCENDING ARTERY, T-GRAFT OF THE RIGHT ANASTOMOSIS, AND I-GRAFT OF THE LEFT ANASTOMOSIS) WAS PERFORMED WITHOUT ARTIFICIAL CIRCULATION. LEFT EVERSION ENDARTERECTOMY. ON (B)(6) 2026, THE PATIENT WAS URGENTLY TAKEN TO THE OPERATING ROOM WITH A LIFE-THREATENING COMPLICATION OF BLEEDING IN THE AREA OF THE SUBORBITAL WOUND ON THE NECK. DURING THE OPERATION, A RUPTURE OF THE POLYPROPYLENE THREAD WITH SIGNS OF FRAYING OF THE FREE EDGES WAS DETECTED IN THE ANASTOMOSIS AREA (SUTURE MATERIAL: OPTILEN 6/0, 2? DR 10B, 3/8, 10 MM, CV PASS, MANUFACTURER BBRAUN, LOT 123152, REF 3097843, EXPIRATION DATE 2028 04 11). IN ORDER TO PREVENT RE-RUPTURE, THE SUTURES WERE UNRAVELED AND THE THREAD WAS REMOVED. A REPEATED ANASTOMOSIS WAS FORMED. THE SUTURE WAS REMOVED FROM THE PACKAGING WITHOUT DAMAGE, AND THERE WAS NO CONTACT BETWEEN THE SUTURE MATERIAL AND MEDICAL INSTRUMENTS PRIOR TO DELAMINATION, WHICH EXCLUDES DAMAGE TO THE SUTURE BY THE SURGEON. PATIENT INFORMATION: MALE, 67 YEARS OLD, 65 KG AND 165 CM. PATIENT OUTCOME: RECOVERY WITH CONSEQUENCES. ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715063 OPTILENE 6/0 (0,7) 75CM 2XDR10B CV2 RCP CARDIAC SUTURE GAW B. BRAUN SURGICAL, S.A. C3097843 123152

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention| S