BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM

    MDR report key: 24650201 · Received March 20, 2026

    Report

    Report Number
    3005099803-2026-01040
    Event Type
    Malfunction
    Date Received
    March 20, 2026
    Date of Event
    February 20, 2026
    Report Date
    April 24, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OCW
    UDI-DI
    00191506049096
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A150205 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF DEVICE DIFFICULT TO ADVANCE.

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A150205 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF DEVICE DIFFICULT TO ADVANCE. DEVICE EVALUATION BLOCK H11 THE RETURNED OVERSTITCH NXT WAS ANALYZED. A VISUAL INSPECTION WAS PERFORMED. THE DEVICE WAS RETURNED WITHOUT THE ANCHOR EXCHANGE. DURING THE VISUAL INSPECTION, THE CATHETER TUBING CHANNEL WAS FOUND TO BE KINKED. ADDITIONALLY, THE TAPE HOOKS WERE DAMAGED, AND THE ENDCAP STRAPS WERE MISSING. THE REPORTED EVENT OF DEVICE DIFFICULT TO ADVANCE COULD NOT BE CONFIRMED. A RISK REVIEW OF THE OVERSTITCH NXT WAS COMPLETED AND CONFIRMED THAT THE EVENTS OF DEVICE DIFFICULT TO ADVANCE, ADDITIONAL DEVICE REQUIRED, CATHETER BENT/KINKED, CATHETER DAMAGED AND ENDCAP DAMAGED, WERE DEFINED IN THE RISK DOCUMENTATION. THESE EVENT TYPES HAVE BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO EVIDENCE THE DEVICE WAS IMPROPERLY USED PER THE INSTRUCTIONS FOR USE (IFU), AND THERE IS NO EVIDENCE THAT THERE IS ANY ISSUE WITH TRANSLATION, WORDING, OR GRAPHICS OF THE IFU/LABELING INFORMATION. BASED ON ALL GATHERED INFORMATION, THE PROBABLE CAUSE SELECTED IS ADVERSE EVENT RELATED TO PROCEDURE, BECAUSE MOST LIKELY PROCEDURAL FACTORS SUCH AS HANDLING OF THE DEVICE AND THE TECHNIQUE USED BY THE PHYSICIAN (FORCE APPLIED), COULD HAVE RESULTED IN THE DAMAGES ENCOUNTERED IN THE DEVICE. FOR THIS REASON, THIS EVENT IS CATALOGUED AS ADVERSE EVENT RELATED TO PROCEDURE BECAUSE THE ADVERSE EVENT OCCURRED DURING THE PROCEDURE AND THE DEVICE HAD NO INFLUENCE ON EVENT. FOR THE EVENT OF DEVICE DIFFICULT TO ADVANCE, THE ISSUE DETECTED DURING THE VISUAL INSPECTION, TUBING CHANNEL KINKED, CAN BE RELATED TO THE MAIN REPORTED EVENT, HOWEVER, SINCE SUCH A FAILURE WOULD ONLY BE OBSERVABLE DURING THE PROCEDURE, AND NO PHOTOS OR EVIDENCE WERE PROVIDED TO CONFIRM THAT THE DEVICE WAS DIFFICULT TO ADVANCE, THE ISSUE WILL BE CLASSIFIED AS CAUSE NOT ESTABLISHED. ADDITIONALLY, FOR THE EVENT ADDITIONAL DEVICE REQUIRED, IT HAPPENED DURING THE PROCEDURE, AND THE MOST PROBABLE CAUSE OF THIS REPORTED ISSUE CANNOT BE ESTABLISHED DUE TO LACK OF EVIDENCE. FOR THIS REASON, WILL BE CLASSIFIED AS CAUSE NOT ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT WAS USED DURING AN ENDOSCOPIC LOCAL GASTRIC RESECTION PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE DEVICE WAS UNABLE TO REACH THE TARGET SITE AND FAILED TO ACHIEVE SUFFICIENT INSUFFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT WAS USED DURING AN ENDOSCOPIC LOCAL GASTRIC RESECTION PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE DEVICE WAS UNABLE TO REACH THE TARGET SITE AND FAILED TO ACHIEVE SUFFICIENT INSUFFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708890 OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW BOSTON SCIENTIFIC CORPORATION M00505420 0037097882 00191506049096

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown