MAUDE Adverse Event Report: IRRAS USA IRRAFLOW CNS CATHETER; INTRACRANIAL CATHETER

Model Number	ICGS020
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Unspecified Nervous System Problem (4426)
Date of Event	03/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Hold for rh 2.3 the patient was diagnosed with ventriculitis and was receiving treatment due to the ventriculitis with the irraflow system.Treatment from the irraflow system began at 11pm.The following day, irras representative and neurocritical care educator, ms.(b)(4), was notified from the medical staff that the patient may be retaining fluid because there was a fluid imbalance between irrigation and drainage (not due to patient condition).The patient was taken to ct scan at approximately 12pm where air was observed in the ventricles and drainage tube.The staff inspected the catheter and discovered a tear in the catheter.There was no noted leakage from the catheter prior to ct scan.The field failure of the icgs020 main catheter body side wall observed on (b)(6) 2022, 12 hours after device placement.As of (b)(6) 2022, abby johnston, irras neurocritical care educator, reported that the patient is doing great under irraflow treatment.Her assessment was that the manipulation was required for the new catheter replacement.Attempts have been made to submit this report for some time.As the new head of ra for irras, needed to open an esg acct.And with esg helpdesk since (b)(6) 2022 to get access to fda's esg due unknow computer problems preventing completion of test esg required submissions.
Additional Manufacturer Narrative
Ct scan results: air in the ventricles was observed.The medical staff examined the catheter to assess the state of the device.Inspection of the catheter found a tear in the catheter (estimated about 3mm) near the distal end of the bifurcation allowing irrigation liquid to leak out of the catheter.The observed hole in the catheter resulted in the decision to replace the catheter.Assessment by reporting institution was that additional procedural trauma resulted from having to remove the damaged catheter and replace with a new sterile catheter to continue with treatment using the irraflow cns system.The catheter was returned and examined.The size of the tear makes it very unlikely that a surgeon would not observe the tear during placement.The complaint description states the leak was identified approximately 12 hours after device placement; it is not clear when the catheter was damaged, whether it was damaged during placement, or the failure occurring later.It is stated that the catheter hole was found after there was a reported imbalance between the irrigation fluid entering the patient and the drainage fluid removed from the patient.Multiple videos and pictures were done showing the damage to the main body of the catheter, between the catheter hub and the main catheter body.The edges of the tear do not appear smooth, but jagged and non-uniform.The material design of the catheter is pellethane 2363 80ae tpe material which tends to resist tear propagation and requires significant stretch prior to break.The jagged cut does not suggest a radial cut due scissors or scalpel, but could leave open the possibility these tools nicked the outer extrusion and the jagged structure was the result of later tearing.Attempts to recreate the tear in the bench top setting were unsuccessful using: razor blade, and a needle.A tentative conclusion can be reached that the irrigation lumen wall was compromised (e.G.Fatigue, thinning, embrittlement, stapling, suturing, scalpel, scissors, or other means) and at the time of the investigation of the catheter post-removal and decontamination, the tear propagated likely due to a force on the catheter as evidenced by the jagged wall formation on each side of the lumen.It cannot be determined how the original damage to the catheter occurred.Discussion with the cmo rose medical was had for review damaged catheter.The cmo stated that the damage looks like it came from the inside out, no direct evidence of a cut or abrasion that would have made a hole so large.Scenario one, user might have put the stylet in the irrigation lumen by mistake.Undetermined the root cause of the failure.A tentative conclusion with reservation is the irrigation lumen wall was compromised (e.G.Fatigue, thinning, embrittlement, stapling, suturing, scalpel, scissors, or other means) and at the time of the investigation of the catheter post-removal and decontamination, the tear propagated likely due to a force on the catheter as evidenced by the jagged wall formation on each side of the lumen.No change to disposition.Monitor post-market surveillance for frequency of occurrence.No further information is expected.

• Brand Name: IRRAFLOW CNS CATHETER
• Common Device Name: INTRACRANIAL CATHETER
• Manufacturer (Section D): IRRAS USA; 11975el 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 ; 8002134604
• MDR Report Key: 16133909
• Report Number: 3013508628-2022-00010
• Device Sequence Number: 11560356
• Product Code: JXG
• UDI-Device Identifier: 00868643000432
• UDI-Public: 00868643000432
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/15/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ICGS020
• Device Catalogue Number: ICGS020
• Device Lot Number: 1009498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown