MAUDE Adverse Event Report: MEDTRONIC IRELAND MICRA; INTRODUCER, CATHETER

Model Number	MI2355A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	03/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported intraoperatively during the attempted implant of a leadless implantable pulse generator (ipg) that the introducer exhibited resistance when inserted into the femoral vein with the dilator.The physician extracted the introducer and reinserted the dilator with no resistance.The introducer was attempted to be inserted with the dilator again but the same resistance was encountered.A new introducer and dilator were attempted but resistance was noted.Femoral vein damage was noted.The introducer was attempted not used and the leadless ipg implant procedure was aborted.The vascular damage was successfully managed with surgical intervention.No further patient complications have been reported as a result of this event.
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.
Additional Manufacturer Narrative
Product event summary: the introducer was returned and analyzed.Analysis indicated the distal seal of the delivery system introducer was torn.Visual analysis of the introducer indicated damage during use.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: MICRA
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business; park west; galway,gw ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business; park west; galway,gw ; EI
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 24740257
• Report Number: 9612164-2026-01639
• Device Sequence Number: 9835292
• Product Code: DYB
• UDI-Device Identifier: 00763000770730
• UDI-Public: (01)00763000770730(17)271215(10)P2F25L0111(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: MI2355A
• Device Catalogue Number: MI2355A
• Device Lot Number: P2F25L0111
• 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: 03/26/2026
• Initial Report FDA Received Date: 03/31/2026
• Date Device Manufactured: 12/16/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown