MAUDE Adverse Event Report: MICRO-TECH(NANJING) CO.,LTD. SPRAY CATHETER

Catalog Number	WP-18/2200
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: during an egd [esophagogastroduodenoscopy] needed to use purastat to stop bleeding and the spray catheter would not push the medication through.Spray catheter ref#: (b)(4).
Additional Manufacturer Narrative
After micro-tech received this incident.We reviewed the manufacturing documents from the device history record and found no abnormalities that would contribute to this issue.We are trying to get more information for investigation.We will fill a follow-up report when this incident investigation is done.
Additional Manufacturer Narrative
1.Incident description: during an egd [esophagogastroduodenoscopy] needed to use purastat to stop bleeding and the spray catheter would not push the medication through.Spray catheter ref# (b)(4).2.External investigation on august 20, 2025, micro-tech has communicated with the customer to see if there is any other clinical usage information.On (b)(6) 2025, the customer replied that they were unable to provide any other information.At the same time, micro-tech conducted an internal investigation and analysis.3.Internal investigations.The investigation and analysis from the aspects of structural design, raw materials, and production processes are as follows: 3.1 structural design.This spray catheter is composed of a nozzle, a screw, a catheter, a protective sleeve, and a handle (luer joint).Analysis: the working principle of spray catheter is "the product is used for lavage, spraying of a stain, or solution, in the gastrointestinal tract by passing through the working channel of a flexible endoscope, therefore, it is judged that the structural design of the spray catheter can meet clinical requirements.This customer feedback is not related to the structural design of the spray catheter.3.2 raw material this spray catheter consists of nozzle, screw, catheter, protective sleeve and handle (luer joint).We have checked the batch of raw materials and found that the material, appearance, and dimensions have all passed the inspection and been put into storage.3.3 production process spray alcohol: use a 20ml syringe to inject alcohol into the spray catheter for spraying.Alcohol should be normally ejected from the distal end of the spray catheter, and the ejected alcohol should be in the shape of mist.If there is block during the process of spraying alcohol, can be discovered in a timely manner.Conclusion: after analyzing and investigating the structural design, raw materials, and production process of the spray catheter, we have not found the root cause of this incident.We will continue to monitor it to ensure patient safety.

• Brand Name: SPRAY CATHETER
• Common Device Name: SPRAY CATHETER
• Manufacturer (Section D): MICRO-TECH(NANJING) CO.,LTD.; no.10 gaoke third road; nanjing national hi-tech, indu; nanjing, jiangsu 21003 2; CH 210032
• Manufacturer (Section G): MICRO-TECH(NANJING) CO.,LTD.; no.10 gaoke third road; nanjing national hi-tech, indu; nanjing, jiangsu 21003 2; CH 210032
• Manufacturer Contact: becky li ; no.10 gaoke third road; nanjing national hi-tech, indu; nanjing, jiangsu 21003-2 ; CH 210032
• MDR Report Key: 22892517
• Report Number: 3004837686-2025-00009
• Device Sequence Number: 8896567
• Product Code: GCE
• UDI-Device Identifier: 06932503562249
• UDI-Public: (01)06932503562249(17)281103(10)M231104311
• Combination Product (Y/N): N
• PMA/510(K) Number: 510K EXEMPT
• 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): 09/19/2025

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 Catalogue Number: WP-18/2200
• Device Lot Number: M231104311
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Female