MAUDE Adverse Event Report: IRRAS USA IRRAFLOW CNS CATHETER; EVD AND IRRIGATION CATHETER

Model Number	ICGS020
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Pneumocephalus (4587)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Control unit component used with subject catheter has been returned and is currently being evaluated-evaluation results and conclusion will be provided with the follow up report.Possible root causes of catheter (not being returned) and/or other system components are: nick in caheter after fixing a loose suture to scalp; issue with stocock when taking csf sample; issue with catheter bifurcation; with negative patient icp, potential with any hole in the system to draw in air; pressure differential could draw air in from arond the catheter (between the wall of the catheter and the dura); patient number two had csf leak unrelated o the catheter insertion on day 7 of treatement, where the clinical staff added suturing-a loose suture could have created a leak in the system where liquid and air could have been introduced.
Event or Problem Description
A complaint was received from mt.Sinai west hospital of two patients that showed an increase in pneumocephalus on day 8 of the irraflow catheter and cns system use.It is believed that the clinical staff had properly primed the system.Data were only provided for the second patient.It was noted that in patient two, the irraflow cns system was the only device currently being in the patient's treatment.The irraflow system was being used in drain mode only.Patient number two had csf leak unrelated o the catheter insertion on day 7 of treatment, where the clinical staff added suturing the device from patient two has been requested to be returned for analysis.The patient's pniumocephalus improved, and the patient remained in the icu due to other treatment.
Event or Problem Description
A complaint was received from (b)(6) hospital of two patients that showed an increase in pneumocephalus on day 8 of the irraflow catheter and cns system use.It is believed that the clinical staff had properly primed the system.No further information is expected.This complaint correction is to change it to a report for patient no.1 only.This follow up is created at fda request to remove h1 box check and remove noe patient no.2 is reported under complaint (b)(4).
Additional Manufacturer Narrative
Control unit component used with subject catheter has been returned and is currently being evaluated-evaluation results and conclusion will be provided with the follow up report.Possible root causes of catheter (not being returned) and/or other system components are: nick in caheter after fixing a loose suture to scalp; issue with stocock when taking csf sample; issue with catheter bifurcation; with negative patient icp, potential with any hole in the system to draw in air; pressure differential could draw air in from arond the catheter (between the wall of the catheter and the dura) the complaint was for 2 patients-this report is for pt.1 only, separated into 2 complaints at fda's request.Pt.2 reported under 3013508628-2022-00015.No further information is expected.

• Brand Name: IRRAFLOW CNS CATHETER
• Common Device Name: EVD AND IRRIGATION CATHETER
• Manufacturer (Section D): IRRAS USA; 11975 el camino real; suite 304; san diego CA 92130
• Manufacturer (Section G): IRRAS USA; 11975 el camino real; suite 304; san diego CA 92130
• Manufacturer Contact: jeanne warner ; 11975 el camino real; suite 304; san diego, CA 92120 ; 8009460458
• MDR Report Key: 15285768
• Report Number: 3013508628-2022-00005
• Device Sequence Number: 7138911
• Product Code: JXG
• UDI-Device Identifier: 00868643000432
• UDI-Public: 00868643000432
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: 200807
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2022

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
• Device Model Number: ICGS020
• Device Catalogue Number: ICGS020
• Device Lot Number: 1009896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown