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

Catalog Number	SENSH2428W
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a thoracic aortic endovascular isolation procedure, the sentrant vascular introducer sheath could not pass through the thoracic aorta stent.There was difficulty in withdrawing the stent delivery device which was noted to be 24f in diameter, and an obvious crease was then observed on the sheath while in vitro.The healthcare professional attempted to withdraw the stent delivery device, which was challenging.After forcefully pulling the thoracic aortic stent delivery system out of the sentrant sheath, the stent was successfully delivered using a non-medtronic large sheath, and the surgery was completed successfully.The sentrant sheath itself was not noted to be difficult to remove from the patient.There was no damage noted on the device or packaging during prep and/or unboxing.The cause of the crease on the sheath could not be determined.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Image analysis two (2) images were received from the account.The device batch number on the shelf carton label matched that reported on gch.The dilator was loaded in the sheath.Deformation was visible to the sheath distal to the seal housing.The reported deformation was confirmed based on the image review.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: SENTRANT INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,ie ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway,ie ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21736803
• Report Number: 9612164-2025-01623
• Device Sequence Number: 12918264
• Product Code: DYB
• UDI-Device Identifier: 00763000716295
• UDI-Public: 00763000716295
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 04/01/2025

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: 06/12/2026
• Device Catalogue Number: SENSH2428W
• Device Lot Number: P2F24E0045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2024
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 63 KG