MAUDE Adverse Event Report: MEDTRONIC, INC. MICRA; INTRODUCER, CATHETER

Model Number	MI2355A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
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
It was reported that during implant of a leadless implantable pulse generator (ipg), the introducer exhibited a leak at the valve.Upon aspirating the valve, air was pulled into the syringe instead of blood.The physician had to continue aspirating while placing their thumb over the back of the introducer to aspirate blood through the introducer instead of air.No patient complications have been reported as a result of this event.

• Brand Name: MICRA
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view,ie ; EI
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view,ie ; EI
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 24363904
• Report Number: 2182208-2026-02792
• Device Sequence Number: 9471415
• Product Code: DYB
• UDI-Device Identifier: 00643169359888
• UDI-Public: (01)00643169359888(17)260716(10)P2F24G0021
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K132030
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2026

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 Expiration Date: 07/16/2026
• Device Model Number: MI2355A
• Device Catalogue Number: MI2355A
• Device Lot Number: P2F24G0021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 02/17/2026
• 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 Age: 64 YR
• Patient Sex: Female
• Patient Weight: 73 KG