BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFREEZE PASSIVE VENTING CATHETER

    MDR report key: 15905625 · Received December 2, 2022

    Report

    Report Number
    1528319-2022-00063
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    November 3, 2022
    Report Date
    December 2, 2022
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    GEH
    UDI-DI
    00857068006013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CATHETER WAS RETURNED FOR EVALUATION AND FOUND TO BE OPERATING ACCORDING TO SPECIFICATION. THE REPORTED EVENT WAS UNABLE TO BE DUPLICATED. THE INSTRUCTIONS FOR USE (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. " STERIS CONDUCTED IN-SERVICE TRAINING SPECIFICALLY ON THE PROPER USE AND OPERATION OF THE TRUFREEZE PASSIVE VENTING CATHETER. A COMPLAINT REVIEW CONFIRMS THE LOT SUBJECT OF THE REPORTED EVENT TO BE ISOLATED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE TRUFREEZE SYSTEM CATHETER AND SCOPE EXPERIENCED ICE BUILD-UP PREVENTING FLOW OF THE GAS INTO THE PATIENT RESULTING IN A PROCEDURE DELAY. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349079 TRUFREEZE PASSIVE VENTING CATHETER TRUFREEZE PASSIVE VENTING CATHETER GEH UNITED STATES ENDOSCOPY GROUP, INC. CD3-001 2506 00857068006013

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown