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

Model Number	ICGS020
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Unspecified Nervous System Problem (4426)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
"we had a cathter leak identified today.The resident swears that the catheter couldn't have been hit with the needle and that it is a spontaneous failure.I think it likely was an incidental needle injury to the catheter.Do you mind showing these pictures to the engineers to get their opinion on how likely this is to be a spontaneous failure and have you heard of this happening before? also, do you happen to know the model of the bold that behnam uses? i think we might like to try it for a few irraflows and see if we like that method better." there was no impact to the patient's treatment, but there was a minor delay in therapy.
Event or Problem Description
"we had a cathter leak identified today.The resident swears that the catheter couldn't have been hit with the needle and that it is a spontaneous failure.I think it likely was an incidental needle injury to the catheter.Do you mind showing these pictures to the engineers to get their opinion on how likely this is to be a spontaneous failure and have you heard of this happening before? also, do you happen to know the model of the bold that behnam uses? i think we might like to try it for a few irraflows and see if we like that method better." there was no impact to the patient's treatment, but there was a minor delay in therapy.This follow up was created at fda request to remove h1 box check and noe box check.

• Brand Name: IRRAFLOW CNS CATHETER
• Common Device Name: EVD 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 92130 ; 8002134604
• MDR Report Key: 15233311
• Report Number: 3013508628-2022-00003
• Device Sequence Number: 20447204
• Product Code: JXG
• UDI-Device Identifier: 00868643000432
• UDI-Public: 00868643000432
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: 2000807
• Number of Events Summarized: 1
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ICGS020
• Device Catalogue Number: ICGS020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 08/16/2022
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (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