MAUDE Adverse Event Report: MICRA; INTRODUCER, CATHETER

Model Number	MI2355A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2026
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 a large amount of thrombus was adhered to the leadless implantable pulse generator (ipg) resulting in a high thresholds.A large amount of thrombus was observed.Although the thrombus at the tip of the leadless ipg could be removed, the internal thrombus could not be completely removed, and contrast could not be delivered and flushing could not be performed.The leadless ipg was not used and replaced.No patient complications have been reported as a result of this event.

• Brand Name: MICRA
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 25591206
• Report Number: 9612164-2026-03215
• Device Sequence Number: 12161931
• Product Code: DYB
• UDI-Device Identifier: 00643169359888
• UDI-Public: (01)00643169359888(17)210104(10)MI2355A
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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: 01/04/2021
• Device Model Number: MI2355A
• Device Catalogue Number: MI2355A
• Device Lot Number: MI2355A
• 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: 06/05/2026
• Initial Report FDA Received Date: 06/23/2026
• 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 Sex: Unknown