BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP

    MDR report key: 22186170 · Received June 11, 2025

    Report

    Report Number
    3005099803-2025-02721
    Event Type
    Malfunction
    Date Received
    June 11, 2025
    Date of Event
    May 21, 2025
    Report Date
    August 20, 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. BLOCK H11: THE RETURNED RESOLUTION CLIP DEVICE WAS ANALYZED, AND A VISUAL AND MICROSCOPIC INSPECTION REVEALED THAT THE DEVICE WAS RETURNED WITHOUT THE CLIP ASSEMBLY AND OUTER SHEATH, SHOWING CLEAR EVIDENCE OF FULL DEPLOYMENT. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. THE REPORTED EVENT OF CLIP PREMATURE DEPLOYMENT WAS NOT CONFIRMED AS THE DEVICE RETURNED FULLY DEPLOYED. INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED WITHOUT THE OUTER SHEATH; THEREFORE, THIS CASE WILL BE CLASSIFIED AS 'CAUSE NOT ESTABLISHED' DUE TO THE UNKNOWN CIRCUMSTANCES THAT LED TO THE DAMAGE. THE RETURNED DEVICE REVIEW SHOWED NO EVIDENCE OF EITHER THE ALLEGED(S) OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS NO PROBLEM DETECTED.

    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.

    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
    90431 RESOLUTION CLIP CLIP, HEMOSTATIC PKL BOSTON SCIENTIFIC CORPORATION M00522610 0032904893 08714729504795

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female