MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. TRUFREEZE SPRAY KIT

Model Number	CO8407030501
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported pneumothorax was detected following a spray cryotherapy procedure which included use of the trufreeze system.Chest tubes were placed to treat the pneumothorax and the patient was later discharged.
Additional Manufacturer Narrative
Through follow-up with the senior clinical research & new product development specialist, we learned that the patient was being treated for strictures post-lung transplant and had several cryotherapy treatments prior to this event.The patient had the lung transplant approximately three years ago and had additional medical issues that were not disclosed.The spray cryotherapy treatment was completed with the expected patient monitoring, and no issues were noted by the attending physician.Pneumothorax was detected following the procedure.The log file of the trufreeze system used in the procedure were reviewed and no abnormalities were found.The trufreeze passive venting catheter was not returned for evaluation.The instructions for use (ifu 15-00509) provides the user with the following information: "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 physician should use caution when considering cryospray for this high-risk patient situation, specifically regarding the ability to vent or extract gas.Physicians should use caution in any procedure or anatomy where a restriction or obstruction interferes with the adequate venting or nitrogen as, resulting in increased gas pressure.During cryospray, the patient must be monitored for abdominal distention and cryospray must be stopped if the abdomen becomes distended, if using in the esophagus.Liquid nitrogen expands more than 700 times when changing from a liquid to a gaseous state.It is imperative for patient safety that adequate venting is used to remove gas created during cryospray." the treating physician requested additional in-service training for clinical staff that work with the trufreeze system.Steris performed in-service training on the proper use and operation of the trufreeze system.No additional issues have been reported.

• Brand Name: TRUFREEZE SPRAY KIT
• Common Device Name: SPRAY KIT
• 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: 15029815
• Report Number: 1528319-2022-00037
• Device Sequence Number: 11901479
• Product Code: GEH
• UDI-Device Identifier: 00857068006013
• UDI-Public: 00857068006013
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 07/15/2022

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
• Device Catalogue Number: C08407030501
• Device Lot Number: UNKNOWN
• 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: 06/15/2022
• Initial Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown