BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT ENDOPROSTHESIS

    MDR report key: 21164052 · Received January 15, 2025

    Report

    Report Number
    2124215-2024-83388
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Date of Event
    December 17, 2024
    Report Date
    February 6, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JCT
    UDI-DI
    08714729204145
    PMA / PMN Number
    K152842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NUMBER G4. PMA/510(K): K980163.

    Additional Manufacturer Narrative · 0

    ADDITIONAL NUMBER G4. PMA/510(K): K980163.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE SIZING DID NOT ALIGN WITH THE BOX LABEL. A 22X70/10 WALLSTENT WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE WALLSTENT SIZING DID NOT MATCH THE DIMENSIONS INDICATED ON THE BOX LABEL AND CHOSE TO REMOVE THE STENT INSTEAD OF DEPLOYING IT. AFTER REMOVAL, THE LAB DEPLOYED THE STENT ON THE TABLE TO ASSESS ITS ACTUAL SIZE AND DETERMINED THAT THE SIZING DID NOT ALIGN WITH THE MEASUREMENTS PROVIDED ON THE BOX. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE SIZING DID NOT ALIGN WITH THE BOX LABEL. A 22X70/10 WALLSTENT WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE WALLSTENT SIZING DID NOT MATCH THE DIMENSIONS INDICATED ON THE BOX LABEL AND CHOSE TO REMOVE THE STENT INSTEAD OF DEPLOYING IT. AFTER REMOVAL, THE LAB DEPLOYED THE STENT ON THE TABLE TO ASSESS ITS ACTUAL SIZE AND DETERMINED THAT THE SIZING DID NOT ALIGN WITH THE MEASUREMENTS PROVIDED ON THE BOX. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE SIZE WAS DETERMINED BY MEASURING THROUGH ANGIOGRAPHY DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1954696 WALLSTENT ENDOPROSTHESIS CATHETER, BILIARY, DIAGNOSTIC JCT BOSTON SCIENTIFIC CORPORATION H965404520 0031288005 08714729204145

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown