MAUDE Adverse Event Report: MEDTRONIC IRELAND SYMPLICITY SPYRAL CATH RDN016; ABLATION CATHETER, RENAL DENERVATION

Model Number	RDN016
Medical Device Problem Codes	Failure to Cycle (1142); High Readings (2459); Positioning Problem (3009)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a renal denervation procedure involving one symplicity spyral catheter and one symplicity g3 generator, the patient's heart rate dropped below twenty beats per minutes (bpm).The patient did not have a history of bradycardia.The vessel being treated was the left renal artery which was severely tortuous and non-calcified.The patient was treated more proximally in tortuous anatomy.The issue was encountered when three ablations were attempted.The cycles were then intentionally stopped within thirty seconds.The patient's heart rate returned to normal immediately after halting ablations and administering atropine.High impedance and/or high temperature rise messages were displayed on the generator and some electrodes shut down.Positioning/advancement difficulties were encountered.It was determined that the proximal segment of the left renal artery was 8-9mm proximally after giving nitroglycerin per standard operating procedure and performing intravascular ultrasound imaging (ivus).It was believed that the spyral catheter functioned properly and that the issue was rather that the inadequate sedation was causing the patient to bear down.It was subsequently attempted to use a non-medtronic renal denervation system.The same bradycardia issue in the patient was encountered when using this system and again resolved immediately after stopping the treatment and administering atropine.The patient's current condition is fine/normal.The iliac artery was slightly tortuous.The procedure was unable to be completed.The spyral catheter was inspected prior to use with no issues noted.The generator was successfully used in a procedure prior to this event.No further patient complications have been reported as a result of this event.
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.
Additional Manufacturer Narrative
Additional information: the generator was used successfully in a procedure subsequent to the event.Annex d code.Correction: three ablations were attempted and each time the patient's heart rate dropped below 20 bpm.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: SYMPLICITY SPYRAL CATH RDN016
• Common Device Name: ABLATION CATHETER, RENAL DENERVATION
• 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: 23615089
• Report Number: 9612164-2025-05776
• Device Sequence Number: 15695421
• Product Code: QYI
• UDI-Device Identifier: 00763000354466
• UDI-Public: (01)00763000354466(17)260904(10)0011939312
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P220026
• 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
• Report Date (Section B): 12/15/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/04/2026
• Device Model Number: RDN016
• Device Catalogue Number: RDN016
• Device Lot Number: 0011939312
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/15/2025
• Date Device Manufactured: 09/05/2023
• 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: Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 101 KG