MAUDE Adverse Event Report: IRRAS USA INC. IRRAFLOW ACTIVE FLUID EXCHANGE SYSTEM; CNS CATHETER

Model Number 2.0

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 09/14/2023

Event Type  Injury  

Event Description

This report involves a case of ventriculitis occurring after use of the irraflow afes treatment.A febrile response was reported on (b)(6) 2023.The caregivers cited the probable cause of the infection to be loosening of staples used for wound closure from the catheter exit point from the skull at the scalp, compromising the seal.Prior to using irraflow, the 40-year-old male patient presented to the hospital with leptomeningeal disease, an occluded v-p shunt, and hydrocephalus.The events occurred over a period from (b)(6) 2023, to (b)(6) 2023.Procedure details: irraflow treatment initiation: (b)(6) 2023.Patient febrile response detected: (b)(6) 2023.Csf sample to confirm ventriculitis: (b)(6) 2023.Transition to drain only mode: (b)(6) 2023.Liquid leakage detected from where the catheter exited the posterior tunneling opening in the scalp between catheter shaft and scalp closure: (b)(6) 2023 (note: the attending care physician believed the leak was due to 'eroding' or relaxing staples at the wound closure site) identification of infection (gram positive cocci/staph epidermis): (b)(6) 2023.Antibiotic administration: initiated on (b)(6) 2023.Irraflow treatment discontinued (catheter removed, patient stable, no additional intervention required): (b)(6) 2023; on (b)(6) 2023, it was reported that the patient remains stable with no identified harm beyond the infection and administration of antibiotics.

Manufacturer Narrative

Investigation report: the catheter was retrieved (intact) and sent to decontamination at cg laboratories (reference coc_decontamination_cglabs_rma23-054).Pictures of the returned catheter are provided in the 'file attachments' tab ((b)(4).The product returned from cg labs was not intact.The catheter returned from cg labs was the tip and 21cm of catheter length.The catheter was investigated post decontamination from cg labs.Only the catheter tip with body was returned (21cm section from tip to detachment location returned).The edge/surface of the catheter and lumens were inspected; the separation suggests a cut and tear rather than a tensile stretch and break (the lumens and outer catheter body edges are intact and undamaged rather than elongated, stretched and distorted).The outer surfaces of the catheter are clean, evidence of dried blood within the tip of the catheter.Padprint dashes for 13 appears 80% removed, suturing covers the 14 cm dash and an intact, formed staple is located at 15 cm mark with 70%.20cm from the tip, transparent dressing appears visible.Investigation conclusion: no determination of how the ventriculitis occurred because the returned catheter was damaged beyond assessment (only 21 cm of the catheter was returned).

Event Description

This report involves a case of ventriculitis occurring after use of the irraflow afes treatment.A febrile response was reported on 2023-09-07.The caregivers cited the probable cause of the infection to be loosening of staples used for wound closure from the catheter exit point from the skull at the scalp, compromising the seal.Prior to using irraflow, the 40-year-old male patient presented to the hospital with leptomeningeal disease, an occluded v-p shunt, and hydrocephalus.The events occurred over a period from (b)(6) 2023.Procedure details: irraflow treatment initiation: (b)(6) 2023.Patient febrile response detected: (b)(6) 2023.Csf sample to confirm ventriculitis: (b)(6) 2023.Transition to drain only mode: (b)(6) 2023.Liquid leakage detected from where the catheter exited the posterior tunneling opening in the scalp between catheter shaft and scalp closure: (b)(6) 2023 (note: the attending care physician believed the leak was due to 'eroding' or relaxing staples at the wound closure site) identification of infection (gram positive cocci/staph epidermis): (b)(6) 2023 antibiotic administration: initiated on (b)(6) 2023 irraflow treatment discontinued (catheter removed, patient stable, no additional intervention required): (b)(6) 2023; on september 12, 2023, it was reported that the patient remains stable with no identified harm beyond the infection and administration of antibiotics.

• Brand Name: IRRAFLOW ACTIVE FLUID EXCHANGE SYSTEM
• Type of Device: CNS CATHETER
• Manufacturer (Section D): IRRAS USA INC.; 11975 el camino real; suite 304; san diego 92130
• Manufacturer (Section G): IRRAS USA INC.
• Manufacturer Contact: jeanne warner
• MDR Report Key: 17945251
• MDR Text Key: 325795674
• Report Number: 3023508628-2023-00007
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222471
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2023

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 Operator: Health Professional
• Device Model Number: 2.0
• Device Catalogue Number: ICGS 020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2023
• Supplement Dates Manufacturer Received: 09/14/2023
• Supplement Dates FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Male