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

Model Number	RDN016
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Insert (1316); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: the symplicity spyral device was inspected after removal from packaging with no issues noted.No extra force was applied during removal.No damage was noted to the guidewire on removal from the patient.A new non-medtronic guidewire and a new replacement spyral catheter with a different lot number were used to complete the ablations.The rdn procedure was successfully completed with the replacement devices.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
Product analysis summary: the device was returned to medtronic for evaluation.A tear was evident to the outer jacket immediately distal to the braided section of the shaft.Resistance was experienced when attempting to load an in-house 0.014" guidewire, it was not possible to fully advance the guidewire.No other deformation evident to the remainder of the device.Image analysis summary: one still image was received for analysis.Image depicts the distal section of a symplicity spyral device.A tear is evident to the outer jacket of the catheter shaft immediately distal to the braided section.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
During a procedure an attempt was made to use one symplicity spyral catheter when entrapment occurred and the catheter was noted to be frayed.The spyral catheter was used for 6 ablations/treatments on a non-medtronic 0.014 guidewire with no issues.As the guidewire was being pulled back into the spyral catheter, resistance was noted.A few techniques were tried but the resistance was still observed.After withdrawing the guidewire and spyral catheter from the patient, it was noted the catheter appeared frayed and hung up on the guidewire.A new guidewire and a new spyral catheter were used to complete the ablations.Both renal arteries were being treated.The renal artery had a small amount of tortuosity present.The iliac artery had no tortuosity present and a little calcification.No patient complications were reported as a result of the procedure.

• 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: 25027928
• Report Number: 9612164-2026-02233
• Device Sequence Number: 10133464
• Product Code: QYI
• UDI-Device Identifier: 00763000354466
• UDI-Public: (01)00763000354466(17)260504(10)0011765038
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 06/19/2026

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 Expiration Date: 05/04/2026
• Device Model Number: RDN016
• Device Catalogue Number: RDN016
• Device Lot Number: 0011765038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Supplement Date Received by Manufacturer: 04/29/2026; 05/26/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/26/2026; 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2023
• 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
• Patient Sex: Female