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 catheter 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 around 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 treatment, 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.Follow up report being provided post initial report, with device evaluation data and investigation report.The investigation of the returned, decontaminated product concluded the catheter's 3-way bonded stopcock straight through female luer port was cracked, resulting in an irrigation leak and potential air ingression.The ufmea was reviewed and the failure mode was identified within 500035 revision f in ufmea id 10.13: ufmea id: 10.13; identified task: disconnecting (or reconnecting) irrigation and or drainage tubing from the catheter; failure mode: luer breaks; hazard: (hz-037); harm: infection (moderate); severity: 2; occ: 2; risk class 2; risk control measures: in person in servicing; training videos on publicly available irras academy app; ifu; 600055, 11.5 note: the harm selected relates to choosing the maximum severity for the chosen hazard.Air embolism or pneumocephalus is generally defined within 500055 revision a with a severity of 1, therefore the proper designation of severity 2 for ufmea id 10.13 is correct.The device investigation of the returned, decontaminated product concluded the catheter body, catheter bifurcation hub and catheter proximal tubes are intact and undamaged.The catheter's 3-way stopcock straight female luer port has evidence of axial cracks.When the luer port is pressurized with liquid water, liquid leaks from the luer port.There is no evidence the catheter was damaged by a suture stick, or that there was damaged along the catheter body or hub.From the complaint information, it cannot be determined if the cranial pressure was negative relative to atmospheric pressure providing a condition where air could be drawn into the cranial cavity resulting in pneumocephalus.The root cause of the catheter's 3-way stopcock straight female luer port developing a stress crack(s) cannot be determined based on the information (tab "info") or the investigation that was completed.All catheters are 100% final inspected for pressure decay prior to shipment and it is likely the stress crack developed during use by the user (it will be assigned "tbd" although it is not likely to be concluded whether this was a user error or a product performance failure).A stress crack developing on the radiation polycarbonate fitting can be due to one or more of the following reasons: user improperly applies solvents and cleaners to the fittings; improper solvent or cleaner without allowing the solvent or cleaner to dry followed by over tightening of the connectors; over tightening the connectors and failing to use the 2-finger tight rule (it is unlikely that, if the 2-finger tight rule was used that the radiation stable common polycarbonate material would develop a stress crack).Common recommendations follow: protecting the connectors from solvent and cleaner wipe down.If wiping down the connector with solvent or cleaners, allow the solvent and cleaner to dry before reconnecting, always use the 2-finger tight rule (or equivalent) when making connections to fittings, and all mechanical features and connections on the irraflow system can be operated without the use of excessive force.If excessive force is applied mechanical feature and connectors can and will break.2-finger tight rule: is a rule created to allow the user to visualize how tight is tight enough and is commonly expressed in hospitals, only tighten connection as hard as you can tighten a connection if holding with 2 fingers.No further information is expected.
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.No additional data were provided for patient one.This complaint is for patient 2, separated into 2 complaints at fda's request.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 treatement, where the clinical staff added suturingthe 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.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: 16328455
• Report Number: 3013508628-2022-00015
• Device Sequence Number: 20790569
• 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: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 09/08/2022

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
• Initial Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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