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	04/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The trufreeze business manager contacted the doctor who performed the procedure to obtain additional information pertaining to the reported event and patient status several times.To date, we have not received a response.No information regarding the results of the x-ray could be obtained despite several attempts made by reaching out to the user facility.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 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." we have no knowledge of the patient's medical history or comorbidities.Steris cannot confirm that the rapid av spray catheter or trufreeze cryospray therapy caused or contributed to the pain experience in the reported event.Out of an abundance of caution, we are reporting this event.A follow-up will be submitted should additional information become available.
Event or Problem Description
The user facility reported that a patient was experiencing pain one week after undergoing a procedure which included use of trufreeze cryospray therapy.The procedure was completed successfully.The patient sought and received additional medical intervention (x-ray).

• 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: 16915309
• Report Number: 1528319-2023-00014
• Device Sequence Number: 20471724
• Product Code: GEH
• UDI-Device Identifier: 00724995199227
• UDI-Public: 00724995199227
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/11/2023

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: 04/11/2023
• Initial Report FDA Received Date: 05/11/2023
• 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