MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. TRUFREEZE PASSIVE VENTING CATHETER

Model Number	CO8407030501
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that a small linear tear was detected in a patient while undergoing a procedure which included use of trufreeze cryospray therapy.Additional medical intervention was required to treat the patient (chest tube and hospitalization).
Additional Manufacturer Narrative
Through follow-up, steris endoscopy learned that the patient was being treated for tracheal stenosis.The linear tear was detected in the patient following three, five second cryotherapy sprays, a steroid injection, and two balloon dilations.A steris product specialist was present during the procedure and advised the doctor to not continue with the cryospray therapy.The doctor elected to continue the procedure and continued the cryospray therapy in another area.The patient's stats dropped (heart rate and o2 levels), and a chest tube was required to be placed to treat the patient.It was reported that the patient stayed overnight at the hospital and was discharged the following day.The instructions for use for the trufreeze system include the following statements, "the physician should carefully consider patient eligibility for cryospray ablation (i.E., cryosurgery and associated gas pressure), including patient presentation, medical history, co-morbidities (e.G., copd, cad), and prolonged use of steroids that may reduce the patient's tissue compliance and tissue strength affecting their ability to tolerate cryospray.Any therapy or procedure compromising the integrity of the tissue, specifically in or adjacent to the targeted ablation area.The physician should use caution when applying cryospray in any organ where stricture or collapse is likely." the log files for the trufreeze system were reviewed and no abnormalities were noted.The steris product specialist offered in-service training on the proper use and operation of the trufreeze system and trufreeze passive venting catheter, however; we are awaiting a response.The lot number of the trufreeze passive venting catheter subject of the reported event was not provided and the device was discarded and could not be returned for evaluation.Without the returned device, the root cause cannot be determined.A follow-up mdr will be submitted when additional information becomes available.
Additional Manufacturer Narrative
It was reported that the patient is doing fine.The steris product specialist completed in-service training on the proper use and operation of the trufreeze system and trufreeze passive venting catheter.No additional issues have been reported.

• Brand Name: TRUFREEZE PASSIVE VENTING CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 17958878
• Report Number: 1528319-2023-00042
• Device Sequence Number: 14768360
• Product Code: GEH
• UDI-Device Identifier: 00724995199289
• UDI-Public: 00724995199289
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CO8407030501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2023
• Supplement Date Received by Manufacturer: 09/24/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown