MAUDE Adverse Event Report: IRRAS USA, INC. IRRAFLOW CATHETER 2.0

Model Number	2.0
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	05/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Irraflow catheter was placed in patient.Nurse noticed water leakage in patient's bed at patient's right arm.Tubing and stopcock had broken.Catheter was placed in or by dr.(b)(6) on (b)(6) 2021.On (b)(6) 2021, rn (b)(6) discovered that there was water in the bed by the patient's right arm during the bed bath.Also, the tubing and stopcok fell apart and the water leakage may have been occurring for some time.(b)(6) took off the broken stopcock and discarded it.A ct scan of the patient's brain showed that there was air in the ventricles.However, the patient did not ned a catheter replacement.

• Brand Name: IRRAFLOW CATHETER 2.0
• Common Device Name: CATHETER 2.0
• Manufacturer (Section D): IRRAS USA, INC.; 11975 el camino real; suite 304; san diego CA 92130
• Manufacturer (Section G): IRRAS USA, INC; 11975 el camino real; suite 304; san diego CA 92130
• Manufacturer Contact: anisha agarwal ; 11975 el camino real; suite 304; san diego, CA 92130 ; 5033827066
• MDR Report Key: 13056388
• Report Number: 3017865540-2021-00001
• Device Sequence Number: 11274005
• Product Code: GWM
• UDI-Device Identifier: 00868643000432
• UDI-Public: 00868643000432
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171880
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 2.0
• Device Catalogue Number: ICGS 020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2021
• Initial Report FDA Received Date: 12/21/2021
• 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: Prefer Not To Disclose