BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION 360 CLIP

    MDR report key: 21761291 · Received April 3, 2025

    Report

    Report Number
    3005099803-2025-01427
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 11, 2025
    Report Date
    June 3, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PKL
    UDI-DI
    08714729875628
    PMA / PMN Number
    K151802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A1 (PATIENT IDENTIFIER): (B)(6). BLOCK E1 (INITIAL REPORTER FACILITY NAME): (B)(6). BLOCK G4 (PREMARKET / 510(K) #): K222503. BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF CLIP UNABLE TO DEPLOY. SECTION E HAS BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON APRIL 7, 2025. BLOCK H11: THE RETURNED RESOLUTION 360 CLIP WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE DEVICE WAS RETURNED WITHOUT THE CLIP ASSEMBLY. THE YOKE WAS STILL ATTACHED TO THE CONTROL WIRE, INDICATING THAT THE CLIP DEPLOYED PREMATURELY. MICROSCOPE INSPECTION SHOWED CLEAR SIGNS OF EARLY DEPLOYMENT. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. THE REPORTED EVENT OF CLIP UNABLE TO DEPLOY CANNOT BE CONFIRMED. UPON ANALYSIS, THE CLIP ASSEMBLY IS ESSENTIAL FOR THE INVESTIGATION BECAUSE THE REPORTED ISSUE IS DIRECTLY RELATED TO IT. TO UNDERSTAND WHAT HAPPENED DURING THE PROCEDURE, THIS PART MUST BE EXAMINED. WHILE THE EXACT CAUSE IS UNCLEAR, THE FAILURE LIKELY RESULTED FROM HOW THE DEVICE WAS USED - SUCH AS TRYING TO OPEN THE CLIP AFTER ACTIVATION, THE PHYSICIAN'S TECHNIQUE, THE ANGLE OR POSITION OF THE SCOPE, OR THE CAPSULE HITTING A SURFACE AND DETACHING; THEREFORE, THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT IS CAUSE NOT ESTABLISHED.

    Additional Manufacturer Narrative · 0

    BLOCK A1 (PATIENT IDENTIFIER): (B)(6). BLOCK E1 (INITIAL REPORTER FACILITY NAME): (B)(6). BLOCK G4 (PREMARKET / 510(K) #): K222503. BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF CLIP UNABLE TO DEPLOY. SECTION E HAS BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON APRIL 7, 2025.

    Additional Manufacturer Narrative · 0

    BLOCK A1 (PATIENT IDENTIFIER): (B)(6). BLOCK E1 (INITIAL REPORTER FACILITY NAME): (B)(6). BLOCK G4 (PREMARKET / 510(K) #): K222503. BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF CLIP UNABLE TO DEPLOY.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP WAS USED IN THE COLON DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE WOUND WAS CLIPPED WITH A LARGE TITANIUM CLIP TO PREVENT BLEEDING. HOWEVER, AFTER CLIPPING, THE WOUND COULD NOT BE DEPLOYED NORMALLY, AND REPEATED ATTEMPTS TO PUSH AND PULL THE HANDLE WERE UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION 360 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 360 CLIP WAS USED IN THE COLON DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE WOUND WAS CLIPPED WITH A LARGE TITANIUM CLIP TO PREVENT BLEEDING. HOWEVER, AFTER CLIPPING, THE WOUND COULD NOT BE DEPLOYED NORMALLY, AND REPEATED ATTEMPTS TO PUSH AND PULL THE HANDLE WERE UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION 360 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 360 CLIP WAS USED IN THE COLON DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE WOUND WAS CLIPPED WITH A LARGE TITANIUM CLIP TO PREVENT BLEEDING. HOWEVER, AFTER CLIPPING, THE WOUND COULD NOT BE DEPLOYED NORMALLY, AND REPEATED ATTEMPTS TO PUSH AND PULL THE HANDLE WERE UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION 360 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
    1846915 RESOLUTION 360 CLIP HEMOSTATIC METAL CLIP FOR THE GI TRACT PKL BOSTON SCIENTIFIC CORPORATION M00521230 0033066918 08714729875628

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female