BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTILENE 7/0 (0,5) 75CM 2XDRC10 CV2 RCP

    MDR report key: 22291792 · Received June 19, 2025

    Report

    Report Number
    3003639970-2025-00329
    Event Type
    Injury
    Date Received
    June 19, 2025
    Date of Event
    May 30, 2025
    Report Date
    June 19, 2025
    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
    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., K133890. SUMMARY OF INVESTIGATION: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED (B)(4) OF THIS CODE-BATCH. THERE ARE (B)(4) IN OUR STOCK. WE HAVE RECEIVED 169 CLOSED SAMPLES FROM CUSTOMER AND 36 CLOSED SAMPLES FROM OUR STOCK. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED FROM CUSTOMER AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 0.21 KGF IN AVERAGE AND 0.193 KGF IN MINIMUM (EP REQUIREMENTS: 0.10 KGF IN AVERAGE AND 0.036 KGF IN MINIMUM). WE HAVE ALSO TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED FROM STOCK AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 0.22 KGF IN AVERAGE AND 0.208 KGF IN MINIMUM (EP REQUIREMENTS: 0.10 KGF IN AVERAGE AND 0.036 KGF IN MINIMUM). BATCH MANUFACTURING RECORD: REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. CONCLUSION ROOT CAUSE ANALYSIS: IT HAS NOT BEEN POSSIBLE TO DETERMINE THE ROOT CAUSE BECAUSE THE SAMPLES RECEIVED COMPLY USP/EP AND B. BRAUN SURGICAL REQUIREMENTS FOR KNOT PULL TENSILE STRENGTH. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FULFIL THE SPECIFICATIONS OF EUROPEAN PHARMACOPOEIA/ B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. THE CASE IS CONSIDERED NOT CONFIRMED BY EVIDENCE OF THE CLOSED SAMPLES RECEIVED. 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 TOWARDS THE END OF THE OPERATION, THERE WERE SEVERE BLEEDINGS DUE TO A TORN THREAD (OPTILENE 7/0 C3097545), RESULTING IN REVISION + HEART-LUNG MACHINE (HLM). NO PATIENT INJURY OCCURRED. TYPE OF OPERATION: BY-PASS. TISSUE SUTURED: VESSEL. CONTINUOUS SUTURING TECHNIQUE EMPLOYED. 8 KNOTS MADE. THE SURGERY WAS PROLONGED. ANASTOMOSIS HAS DISSOLVED AFTER THE KNOT, OR THREAD IS BROKEN. THREAD BRITTLE, RESULTING IN SECONDARY BLEEDING. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864772 OPTILENE 7/0 (0,5) 75CM 2XDRC10 CV2 RCP CARDIAC SUTURE GAW B. BRAUN SURGICAL, S.A. C3097545 625134

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention