BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP

    MDR report key: 22235658 · Received June 17, 2025

    Report

    Report Number
    3005099803-2025-02720
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    May 21, 2025
    Report Date
    August 21, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PKL
    UDI-DI
    08714729504795
    PMA / PMN Number
    K142973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G4 (PREMARKET / 510(K) #): K222503. BLOCK H6: IMDRF DEVICE CODE A150103 CAPTURES THE REPORTABLE EVENT OF CLIP PREMATURE DEPLOYMENT WITH ANATOMICAL LOCATION OF ESOPHAGUS.

    Additional Manufacturer Narrative · 0

    BLOCK G4 (PREMARKET / 510(K) #): K222503. BLOCK H6: IMDRF DEVICE CODE A150103 CAPTURES THE REPORTABLE EVENT OF CLIP PREMATURE DEPLOYMENT WITH ANATOMICAL LOCATION OF ESOPHAGUS. BLOCK H11: THE RETURNED RESOLUTION CLIP WAS ANALYZED, AND A VISUAL EVALUATION NOTED THE DEVICE WAS RETURNED WITH THE CLIP ASSEMBLY DETACHED, BOTH ARMS BENT, AND THE OUTER SHEATH MISSING, WITH MICROSCOPE INSPECTION CONFIRMING FULL DEPLOYMENT AND BENT ARMS. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. THE REPORTED EVENT OF CLIP PREMATURE DEPLOYMENT WAS NOT CONFIRMED AS THE CLIP ASSEMBLY RETURNED FULLY DEPLOYED. UPON ANALYSIS, IT WAS FOUND THAT THE BENT CLIP ARMS WERE LIKELY CAUSED BY PROCEDURAL FACTORS, SUCH AS ATTEMPTING TO GRASP TISSUE LARGER THAN THE CLIP COULD ACCOMMODATE, LEADING TO DEFORMATION AND IMPAIRED CLOSURE. THE MISSING OUTER SHEATH IS CLASSIFIED AS "CAUSE NOT ESTABLISHED" DUE TO UNKNOWN CIRCUMSTANCES. THEREFORE, THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT IS ADVERSE EVENT RELATED TO PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP WAS USED IN THE ESOPHAGUS DURING A GASTROSCOPIC TREATMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE TIP OF THE CLIP FELL OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP WAS USED IN THE ESOPHAGUS DURING A GASTROSCOPIC TREATMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE TIP OF THE CLIP FELL OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1628693 RESOLUTION CLIP CLIP, HEMOSTATIC PKL BOSTON SCIENTIFIC CORPORATION M00522610 0032904893 08714729504795

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female