BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDOFLIP CATHETER

    MDR report key: 12089949 · Received June 30, 2021

    Report

    Report Number
    3006897778-2021-00001
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    May 3, 2021
    Report Date
    June 30, 2021
    Manufacturer
    CROSPON LTD
    Product Code
    FFX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: PERORAL ENDOSCOPIC MYOTOMY: 10-YEAR OUTCOMES FROM A LARGE, SINGLE-CENTER U.S. SERIES WITH HIGH FOLLOW-UP COMPLETION AND COMPREHENSIVE ANALYSIS OF LONG-TERM EFFICACY, SAFETY, OBJECTIVE GERD, AND ENDOSCOPIC FUNCTIONAL LUMINAL ASSESSMENT SOURCE: GASTROINTESTINAL ENDOSCOPY ACCEPTED DATE: 3 MAY 2021. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED OCTOBER 2009 TO OCTOBER 2019, 610 CONSECUTIVE PATIENTS INCLUDED IN THE STUDY FOR TREATING ACHALASIA WITH PERORAL ENDOSCOPIC MYOTOMY (POEM). ONE ESOPHAGEAL PUNCTATE PERFORATION WHICH OCCURRED BEFORE THE POEM WAS CAUSED BY THE EARLY VERSION OF THE CATHETER WHICH LACKED A FLOPPY ATRAUMATIC TIP. THIS LED TO TRANSIENT SELF-LIMITED LEFT PNEUMOTHORAX THAT SPONTANEOUSLY AND RAPIDLY RESOLVED AFTER CLOSURE OF THE MICROPERFORATION WITH AN ENDOCLIP. THE POEM WAS THEN PERFORMED SUCCESS FULLY IN THE SAME SESSION. STAVROS N. STAVROPOULOS, MD, FASGE, AGAF., 3 MAY 2021, PERORAL ENDOSCOPIC MYOTOMY: 10-YEAR OUTCOMES FROM A LARGE, SINGLE-CENTER U.S. SERIES WITH HIGH FOLLOW-UP COMPLETION AND COMPREHENSIVE ANALYSIS OF LONG-TERM EFFICACY, SAFETY, OBJECTIVE GERD, AND ENDOSCOPIC FUNCTIONAL LUMINAL ASSESSMENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993434 UNKNOWN ENDOFLIP CATHETER FFX CROSPON LTD UNKNOWN ENDOFLIP CATHETER

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention