BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION 360 CLIP

    MDR report key: 9706417 · Received February 13, 2020

    Report

    Report Number
    3005099803-2020-00442
    Event Type
    Malfunction
    Date Received
    February 13, 2020
    Date of Event
    January 24, 2020
    Report Date
    February 13, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PKL
    UDI-DI
    08714729875635
    PMA / PMN Number
    K151802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT: (B)(6) KG. (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP DEVICE WAS USED IN THE FUNDUS OF STOMACH DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP GRASPED AND LOCKED ONTO TISSUE, BUT FAILED TO RELEASE FROM THE CATHETER TO DEPLOY. REPORTEDLY, THE DEVICE WAS WIGGLED LOOSE USING THE SCOPE, AND THE CLIP WAS REMOVED FROM THE PATIENT. IT WAS ALSO NOTICED THAT THE CONTROL WIRE SNAPPED INSIDE THE HANDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION 360 CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171313 RESOLUTION 360 CLIP HEMOSTATIC METAL CLIP FOR THE GI TRACT PKL BOSTON SCIENTIFIC CORPORATION M00521231 0024790275 08714729875635

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR