BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX ESOPHAGEAL

    MDR report key: 21172058 · Received January 16, 2025

    Report

    Report Number
    3005099803-2025-00067
    Event Type
    Malfunction
    Date Received
    January 16, 2025
    Date of Event
    December 19, 2024
    Report Date
    January 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ESW
    UDI-DI
    08714729765240
    PMA / PMN Number
    K073266
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G4: PREMARKET/510(K) K073266, K233939 - REPORTED HERE AS IT EXCEEDED THE NUMBER OF MAXIMUM CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF PARTIALLY DEPLOYED ESOPHAGEAL STENT.

    Additional Manufacturer Narrative · 0

    BLOCK B5 HAS BEEN CORRECTED. BLOCK G4: PREMARKET/510(K) K073266, K233939 - REPORTED HERE AS IT EXCEEDED THE NUMBER OF MAXIMUM CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF PARTIALLY DEPLOYED ESOPHAGEAL STENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL STENT WAS TO BE USED TO TREAT AN IMPASSABLE ESOPHAGEAL CANCER DURING A PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE. THE DEVICE COULD NOT PASS THROUGH THE TUMOUR. THE DEVICE WAS REMOVED WAS THEN REMOVED FROM THE PATIENT. UPON INSPECTION, IT WAS NOTED THAT THE TIP OF THE DELIVERY SYSTEM WAS SLIGHTLY SEPARATED FROM THE SHEATH. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL STENT WAS TO BE USED TO TREAT AN IMPASSABLE ESOPHAGEAL CANCER DURING A PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE DEVICE COULD NOT PASS THROUGH THE TUMOR. THE DEVICE WAS THEN REMOVED FROM THE PATIENT. UPON INSPECTION, IT WAS NOTED THAT THE TIP OF THE DELIVERY SYSTEM WAS SLIGHTLY SEPARATED FROM THE SHEATH. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510688 WALLFLEX ESOPHAGEAL PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC CORPORATION M00516900 0035106337 08714729765240

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown