MAUDE Adverse Event Report: MEDTRONIC MICRA; INTRODUCER, CATHETER

Model Number	MI2355A
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sheath was not air tight during the implant of a leadless implantable pulse generator (ipg).It was attempted/not used.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
F1 user facility: (b)(6) hospital.F2 uf/importer report number: (b)(4).F3 user facility name/address: (b)(6).F4 contact person: (b)(6).F5 phone number: (b)(6).F6 date user facility became aware of the event.F7 type of report: initial.F8 date of this report: mar-2026.F9 approximate age of device.F10 event problem codes: health effect ¿ clinical code health effect ¿ impact code medical device problem code component code f11 report sent to fda: f12 location where event occurred: hospital.F13 report sent to manufacturer: yes.F14 manufacturer name and address: mfr.Name: medtronic address: 8200 coral sea street ne.City: mounds view.State: mn.Zip: 55112f1.User facility (b)(6) hospital.F2 uf/importer report number: (b)(4).F3 user facility name/address: (b)(6).F4 contact person: (b)(6).F5 phone number: (b)(6).F6 date user facility became aware of the event.F7 type of report: initial.F8 date of this report: mar-2026.F9 approximate age of device.F10 event problem codes: health effect ¿ clinical code health effect ¿ impact code medical device problem code component code.F11 report sent to fda.F12 location where event occurred: hospital.F13 report sent to manufacturer: yes.F14 manufacturer name and address: mfr.Name: medtronic address: 8200 coral sea street ne.City: mounds view.State: mn.Zip: 55112.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
Corrected h10 (value previously included in h11).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; galway
• Manufacturer (Section G): MEDTRONIC; galway
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 24800144
• Report Number: 9612164-2026-01749
• Device Sequence Number: 10667074
• Product Code: DYB
• UDI-Device Identifier: 00643169359888
• UDI-Public: (01)00643169359888(17)271119(10)P2F25L0058
• Combination Product (Y/N): N
• 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: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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: MI2355A
• Device Catalogue Number: MI2355A
• Device Lot Number: P2F25L0058
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 04/20/2026
• Date Device Manufactured: 11/20/2025
• 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: Female
• Patient Weight: 55 KG
• Patient Race: White