BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERSTITCH 2-0 POLYPROPYLENE SUTURE

    MDR report key: 22585570 · Received July 24, 2025

    Report

    Report Number
    3005099803-2025-03433
    Event Type
    Malfunction
    Date Received
    July 24, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 24, 2025
    Manufacturer
    APOLLO ENDOSURGERY
    Product Code
    OCW
    UDI-DI
    10811955020732
    PMA / PMN Number
    K191439
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK E1 THE COMPLAINANT WAS UNABLE TO PROVIDE THE INITIAL REPORTER FIRST NAME. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BLOCK H6 DEVICE CODE A0401 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF SUTURE BREAK.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH 2-0 POLYPROPYLENE SUTURE WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE PERFORMED ONJ(B)(6) 2025 DURING THE PROCEDURE, THE SUTURE BROKE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1604744 OVERSTITCH 2-0 POLYPROPYLENE SUTURE ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW APOLLO ENDOSURGERY PLY-G02-020-APL 24SE12529 10811955020732

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Female