MAUDE Adverse Event Report: MEDTRONIC DOMINICANA CATHETER PASSER; CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TER

Model Number	8591-60
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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
Information was received from a healthcare provider (hcp) via a company representative (rep) regarding an 8591-60 passer.The event occurred during simulated use pre-clinical study conducted at medtronic prl with a cadaver donor using the model 8591 catheter passer.The intent was to gather simulated use data with representative physician users to support upcoming submissions to expand the product indication to include spinal cord stimulation (scs).Currently the model 8591 catheter passer was indicated to support targeted drug delivery (tdd) systems.Model 8591 catheter passer was being used to tunnel.The physician had used the tunneling tool to create a tunneling path, and when removing the obturator from the tunneling tool, the obturator tab broke off of the obturator.The remaining activities for the simulated use study session were completed without any other issues.
Additional Manufacturer Narrative
H3: the returned device was subjected to a series of standard tests that include but is not limited to visual inspection and functional testing.Analysis identified the obturator was broken.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: CATHETER PASSER
• Common Device Name: CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TER
• 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 ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22301762
• Report Number: 9612501-2025-01585
• Device Sequence Number: 8628643
• Product Code: MAJ
• UDI-Device Identifier: 00763000031411
• UDI-Public: (01)00763000031411(17)300313(10)0231081835
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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: 8591-60
• Device Catalogue Number: 8591-60
• Device Lot Number: 0231081835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2025
• 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