MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED SPETZLER LUMBAR-PERITONEAL SHUNT KIT, 105CM CATHETER

Model Number	NT97105S01
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Bacterial Infection (1735); Meningitis (2389)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial report ref to natus complaint # (b)(4).Clinical trail performed by biodexa pharma in the us.Reference to mfr report # 2024-us-000053.Although infection, including meningitis, is documented with lumbar peritoneal shunt systems, the off-label use of the catheter in this study has caused the device deficiency to be an expedited reportable serious adverse device effect (sade)." device will not be returned for evaluation.Ifu states: "infections can occur secondary to systemic infection of the drainage mechanism.Such infections can lead to arachnoiditis and are best treated by catheter removal and appropriate antibiotic therapy." as well as "complications such as infection, air leakage into the subarachnoid space, and fluid leakage may occur randomly at any time during or after the procedure." further investigation to be carried out.
Event or Problem Description
Part nt97105s01 - spetzler lumbar-peritoneal shunt kit, 105cm catheter.The catheter was implanted in the subject on (b)(6) 2023.Following insertion of the catheter there was delayed wound healing of the forehead wound.The catheter was explanted on (b)(6) 2024.The off-label use of the catheter in this study (mtx110-102) has caused the device deficiency to be an expedited reportable serious adverse device effect (sade).Related to medwatch form ref.Mfr report # 2024-us-000053.
Additional Manufacturer Narrative
Follow up report 001 ref to natus complaint # (b)(4).No associated capas complaint history review/trend analysis: 0 previously confirmed "integ-infection" complaints within the past two years.(b)(4) nt97105s01 units sold within past two years.Failure rate = 0.00% risk management review: (identify hazard id) a review of (b)(4) medical device hazard analysis (rev 01), identifies the hazard situation as "7.2 device contamination." the risk level is considered moderate.Based on complaint of "bacterial infection." this determination is based on the information received from the customer.Root cause/failure investigation: the customer did not return the device for evaluation.Ifu states: "infections can occur secondary to systemic infection of the drainage mechanism.Such infections can lead to arachnoiditis and are best treated by catheter removal and appropriate antibiotic therapy," as well as "complications such as infection, air leakage into the subarachnoid space, and fluid leakage may occur randomly at any time during or after the procedure." off-label use may have contributed to reported infection.No further action is required.Failure mode: no device returned - unable to determine.
Event or Problem Description
Part nt97105s01 - spetzler lumbar-peritoneal shunt kit, 105cm catheter.The catheter was implanted in the subject on (b)(6) 2023.Following insertion of the catheter there was delayed wound healing of the forehead wound.The catheter was explanted on (b)(6) 2024.The off-label use of the catheter in this study (mtx110-102) has caused the device deficiency to be an expedited reportable serious adverse device effect (sade).Related to medwatch form ref.Mfr report # (b)(4).

• Brand Name: SPETZLER LUMBAR-PERITONEAL SHUNT KIT, 105CM CATHETER
• Common Device Name: SPETZLER LUMBAR-PERITONEAL SHUNT KIT, 105CM CATHETER
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5955 pacific center boulevard; san diego; CA 92121
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; h91pd92, ; EI
• Manufacturer Contact: gráinne walsh ; 5955 pacific center boulevard; san diego, CA 92121
• MDR Report Key: 20367324
• Report Number: 2023988-2024-00068
• Device Sequence Number: 3795892
• Product Code: JXG
• UDI-Device Identifier: 00382830057288
• UDI-Public: 00382830057288
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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
• Operator of Device: Health Professional
• Device Model Number: NT97105S01
• Device Catalogue Number: NT97105S01
• Device Lot Number: 0228470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 11/19/2024
• 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: Hospitalization; Other
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White