BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE

    MDR report key: 5624471 · Received May 3, 2016

    Report

    Report Number
    5624471
    Event Type
    Malfunction
    Date Received
    May 3, 2016
    Date of Event
    March 29, 2016
    Report Date
    April 19, 2016
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KCF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE FIRST BALLOON DILATOR (LOT# 18884819) THAT WAS USED DID NOT GO ALL THE WAY THROUGH THE BIOPSY CHANNEL. IT WAS TRIED TWICE WITH NO SUCCESS. THE BALLOON CATHETER WOULD GET JAMMED/STUCK IN THE SCOPE. THE CATHETER WAS REMOVED AND A NEW CATHETER WAS USED TO DILATE ESOPHAGUS. THE SECOND BALLOON CATHETER (LOT# 18846982) WOULD NOT DEFLATE 100% FOR IT TO BE REMOVED SAFELY THROUGH THE SCOPE. THE SCOPE HAD TO BE REMOVED FROM THE PATIENT AND THE BALLOON PORTION OF THE CATHETER WAS CUT/SEPARATED FROM THE REST OF THE CATHETER. THE REMAINING PART OF THE BALLOON CATHETER WAS SAFELY REMOVED FROM SCOPE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH A NEW CATHETER WITH NO COMPLICATIONS TO THE PATIENT. MANUFACTURER RESPONSE FOR ESOPHAGEAL BALLOON CATHETER, CRE ESOPHAGEAL FIXED WIRE 18-20 (PER SITE REPORTER): SENT 2 REPLACEMENTS. OBTAINED INFORMATION FOR THEIR REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282757 CRE DILATOR, ESOPHAGEAL KCF BOSTON SCIENTIFIC CORPORATION 18884819

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR