MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. RAPID AV SPRAY CATHETER KIT

Model Number	2000177
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The catheter was not returned for evaluation.Without the return of the catheter the complaint cannot be confirmed, and the cause of the reported issue cannot be determined.The log files were reviewed for the trufreeze console, and no abnormalities were noted.The instructions for use state (p.3), "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." the doctor who performed the procedure subject of the reported event stated that the event was due to user error.The steris chief medical officer (cmo) offered counseling to the doctor who performed the procedure subject of the reported event however, the doctor declined.A follow-up report will be submitted should additional information become available.No additional issues have been reported.
Event or Problem Description
The user facility reported that a patient had a linear tear near the mid-esophagus a few weeks after undergoing a procedure to treat a tumor which included use of trufreeze cryospray therapy.The patient had developed pneumomediastinum and sought and received additional medical intervention.

• Brand Name: RAPID AV SPRAY CATHETER KIT
• Common Device Name: RAPID AV SPRAY CATHETER 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: 17276718
• Report Number: 1528319-2023-00025
• Device Sequence Number: 19721546
• Product Code: GEH
• UDI-Device Identifier: 00724995199227
• UDI-Public: 00724995199227
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2023

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: 2000177
• Device Catalogue Number: 2000177
• 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: 06/09/2023
• Initial Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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