MAUDE Adverse Event Report: MEDTRONIC VASCULAR SENTRANT INTRODUCER SHEATH; INTRODUCER, CATHETER

Catalog Number	SENSH1428W
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
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
A sentrant sheath was used as a conduit during an unknown procedure.It was reported during the index procedure, when the sentrant sheath was introduced into the patient's femoral inline, there was a failure at the tip of the sentrant which made device navigation impossible.A replacement sentrant from the same batch that had no defects was used and the treatment proceeded as expected.The cause was not reported.No additional clinical sequelae were reported and the patient is fine.

• Brand Name: SENTRANT INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC VASCULAR; 3576 unocal pl; santa rosa, CA
• Manufacturer (Section G): MEDTRONIC VASCULAR; 3576 unocal pl; santa rosa, CA
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 25482777
• Report Number: 2953200-2026-00023
• Device Sequence Number: 18728279
• Product Code: DYB
• UDI-Device Identifier: 00763000716240
• UDI-Public: (01)00763000716240(17)271028(10)P2F25K0045(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K123990
• 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): 06/12/2026

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 Catalogue Number: SENSH1428W
• Device Lot Number: P2F25K0045
• 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: 05/19/2026
• Initial Report FDA Received Date: 06/12/2026
• Date Device Manufactured: 10/28/2025
• 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