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

Model Number	SENSH1428W
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
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 a transcatheter aortic valve replacement, the sheath sensh1428w sentrant hydro experienced a sheath valve detachment when the valve came off with the dilator, resulting in backflow of blood.The device was replaced with a new sheath.The sentrant was used as per instructions for use (ifu) and appeared normal prior to use.The patient experienced a blood loss of 750 ml and received a transfusion of one unit of blood due to the blood loss associated with the sentrant sheath per the physician the cause of the detachment could not be determined.
Additional Manufacturer Narrative
Product analysis the sheath and obturator were received separated with the valve and end cap detached from the sheath and present on the obturator.Minor deformation was evident to the end cap tab and sheath window.No deformation was evident to the valve.The valve and end-cap could be reloaded into the sheath with no issues noted.No other deformation evident to the remainder of the device.The reported detachment could be confirmed through analysis.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
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: 22335397
• Report Number: 9612164-2025-03166
• Device Sequence Number: 21097369
• Product Code: DYB
• UDI-Device Identifier: 00763000716240
• UDI-Public: (01)00763000716240(17)260829(10)P2F24H0066(20)01
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2025

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 Expiration Date: 08/29/2026
• Device Model Number: SENSH1428W
• Device Catalogue Number: SENSH1428W
• Device Lot Number: P2F24H0066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 08/12/2025; 09/08/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 09/04/2025; 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female