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

Model Number	2000516
Medical Device Problem Codes	Infusion or Flow Problem (2964); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapid av spray catheters are being returned for evaluation following the reported event.The instructions for use (1500503) provides the following information to the user: "do not use the product if the device does not function properly or there is evidence of damage (e.G.Kinks, bends or damaged packaging).Save the device and packaging and contact your local steris endoscopy product specialist." the device history record (dhr) for the subject lot was reviewed and confirmed the devices was manufactured to specifications; no abnormalities were noted.A complaint review was conducted and confirmed this to be an isolated event.Our investigation and evaluation of the catheters are in process; a follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that three of their rapid av spray catheters would not spray properly resulting to a procedure delay.The procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
Two of the reported devices were returned to steris for investigation and evaluated by engineering.The evaluation found that there were slight kinks found on both devices, but the devices operated as expected.There were no issues observed with the spray for either device.A root cause of the reported event could not be determined as the issue could not be duplicated.No additional issues have been reported.

• Brand Name: RAPID AV SPRAY CATHETER
• Common Device Name: RAPID AV 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: 19731411
• Report Number: 1528319-2024-00057
• Device Sequence Number: 8327562
• Product Code: GEH
• UDI-Device Identifier: 00724995199326
• UDI-Public: 00724995199326
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 07/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2000516
• Device Catalogue Number: 2000516
• Device Lot Number: 4511
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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