MAUDE Adverse Event Report: MEDTRONIC IRELAND FLEXCATH CONTOUR¿ STEERABLE SHEATH; CATHETER, STEERABLE

Model Number	10FCC13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aortic dissection (4870)
Date of Event	09/08/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Continuation of d10: product id: pscc100 product type: catheter product id: non-medtronic product type: guidewire.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 pulsed field ablation procedure, when the catheter was removed there was tissue adhered to the catheter.The case was completed with pulsed field ablation.No patient complications have been reported as a result of this event.2025-12-19: additional information was received indicating that the guidewire extending from the tip of the pulseselect became caught on the chordae tendineae, resulting in chordal rupture.Subsequently, the patient was transferred to another hospital on the same day, where surgery was performed.The postoperative course was favorable, and rehabilitation progressed well.However, it was later reported that the patient developed aortic dissection and died.
Event or Problem Description
It was later reported that both pulsed field ablation and radiofrequency (rf) were used during the procedure.Additionally, the physician stated that the patient died of aortic dissection a few months after the procedure, the incident was not related to medtronic products or procedure.
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: FLEXCATH CONTOUR¿ STEERABLE SHEATH
• Common Device Name: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24161629
• Report Number: 9612164-2026-00437
• Device Sequence Number: 9138326
• Product Code: DRA
• UDI-Device Identifier: 00763000659080
• UDI-Public: (01)00763000659080(17)270630(10)0012894665(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K232321
• 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,Followup
• Report Date (Section B): 03/05/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 10FCC13
• Device Catalogue Number: 10FCC13
• Device Lot Number: 0012894665
• 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: 12/26/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 03/05/2026
• Date Device Manufactured: 06/30/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown