BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFREEZE SPRAY KIT

    MDR report key: 14317284 · Received May 7, 2022

    Report

    Report Number
    1528319-2022-00025
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    November 8, 2021
    Report Date
    May 6, 2022
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE SUBJECT OF THE EVENT WAS NOT RETURNED FOR EVALUATION. WITHOUT A RETURNED DEVICE, THE ROOT CAUSE CANNOT BE DETERMINED. STATEMENTS IN THE INSTRUCTIONS FOR USE INCLUDE: (IFU 15-00133-12) GIVE THE USER THE FOLLOWING CAUTIONS WHEN USING THE TRUFREEZE CATHETERS, "WHEN USING A SCOPE, PLACE THE CATHETER THROUGH THE CATHETER INTRODUCER AND INTO THE BIOPSY OR WORKING CHANNEL OF THE SCOPE. ENSURE CATHETER AND SCOPE ARE COMPLETELY DEFROSTED BEFORE REPOSITIONING OR WITHDRAWING CATHETER. WITHDRAW CATHETER IN THE STRAIGHT POSITION. CARE SHOULD BE TAKEN TO AVOID KINKING OR FRACTURING THE CATHETER DURING HANDLING AND INSERTION INTO THE CATHETER INTRODUCER. CAUTION: IF USING A SCOPE IN THE RETROFLEXED POSITION, ENSURE CATHETER AND SCOPE ARE COMPLETELY DEFROSTED BEFORE REPOSITIONING OR WITHDRAWING. WITHDRAW SCOPE AND CATHETER IN THE STRAIGHT POSITION. CAUTION: ENSURE CATHETER AND SCOPE ARE COMPLETELY DEFROSTED BEFORE REPOSITIONING OR WITHDRAWING CATHETER. WITHDRAW CATHETER IN THE STRAIGHT POSITION. CAUTION: CARE SHOULD BE TAKEN TO AVOID KINKING OR FRACTURING THE CATHETER DURING HANDLING AND INSERTION INTO THE CATHETER INTRODUCER. " A STERIS ENDOSCOPY PRODUCT SPECIALIST OFFERED IN-SERVICE TRAINING ON THE PROPER USE AND HANDLING OF THE TRUFREEZE PASSIVE VENTING CATHETER, HOWEVER, THE USER FACILITY HAS DECLINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED VIA MEDWATCH REPORT # (B)(4) THAT DURING A PATIENT PROCEDURE THEIR TRUFREEZE PASSIVE VENTING CATHETER BROKE INTO TWO PIECES BETWEEN THE CONSOLE AND THE BIOPSY PORT OF THE SCOPE. THE SCOPE WAS IMMEDIATELY REMOVED. USER FACILITY PERSONNEL USED AN ADDITIONAL TRUFREEZE PASSIVE VENTING CATHETER TO COMPLETE THE PROCEDURE. NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078184 TRUFREEZE SPRAY KIT SPRAY KIT GEH UNITED STATES ENDOSCOPY GROUP, INC. C08407030501 1506

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown