MAUDE Adverse Event Report: MEDTRONIC DOMINICANA EDM LUMBAR CATHETER, CLOSED TIP, BARIUM IMPREGNATED, 80 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	46419
Medical Device Problem Codes	Break (1069); Fracture (1260); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information regarding a catheter.It was reported that during an emergency lumbar drain insertion, after insertion of the trocar and confirmation of cerebrospinal fluid (csf) drainage, the lumbar drain catheter was introduced.Resistance was felt during insertion, and the trocar was repositioned.On the second attempt, resistance was still present, and a guide wire was used.Despite this, resistance persisted, and upon withdrawal, it was observed that the lumbar drain catheter had fractured.
Additional Manufacturer Narrative
H3.Product analysis determined that the visual inspection confirmed the catheter had been damaged/torn.The damage to the catheter appeared to have been from the removal process.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: EDM LUMBAR CATHETER, CLOSED TIP, BARIUM IMPREGNATED, 80 CM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer (Section G): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer Contact: justin ellis ; 4620 n. beach st.; fort worth, TX 76137 ; 7635265677
• MDR Report Key: 22893320
• Report Number: 9612501-2025-02264
• Device Sequence Number: 5802589
• Product Code: JXG
• UDI-Device Identifier: 00763000027285
• UDI-Public: (01)00763000027285(17)290322(10)0228675005
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K862303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2025

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: 46419
• Device Catalogue Number: 46419
• Device Lot Number: 0228675005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• 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
• Patient Sex: Unknown