MAUDE Adverse Event Report: IRRAS USA, INC. IRRAS; IRRAFLOW CNS SYSTEM CONTROL UNIT (ICCU 020)

Model Number	N/A
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the care team on site, overdrainage can occur w/ traditional evd treatment as well.
Event or Problem Description
Overdrainage during treatment of traumatic iph resulted in secondary subdural hematoma.During the treatment of a traumatic iph with ventricular extension using the irraflow system, excessive fluid removal was observed, and the patient developed a secondary subdural hematoma, which was potentially caused by overdrainage of csf from the ventricles.Treatment continued as normal with the patient's neurological exam continuing to improve from the time that the bleed was first observed.At the conclusion of treatment, the patient was discharged home in a normal manner, and no additional procedures were required.
Additional Manufacturer Narrative
Per the care team on site, overdrainage can occur w/ traditional evd treatment as well.
Event or Problem Description
Overdrainage during treatment of traumatic iph resulted in secondary subdural hematoma.During the treatment of a traumatic iph with ventricular extension using the irraflow system, excessive fluid removal was observed, and the patient developed a secondary subdural hematoma, which was potentially caused by overdrainage of csf from the ventricles.Treatment continued as normal with the patient's neurological exam continuing to improve from the time that the bleed was first observed.At the conclusion of treatment, the patient was discharged home in a normal manner, and no additional procedures were required.

• Brand Name: IRRAS
• Common Device Name: IRRAFLOW CNS SYSTEM CONTROL UNIT (ICCU 020)
• Manufacturer (Section D): 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 ; 8001234604
• MDR Report Key: 13056460
• Report Number: 3017865540-2021-00002
• Device Sequence Number: 2045722
• Product Code: GWM
• UDI-Device Identifier: 00868643000401
• UDI-Public: 00868643000401
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2021

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: N/A
• Device Catalogue Number: ICCU 020
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• 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): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male