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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis summary: a kink was evident to catheter shaft.A guidewire was loaded in the device on device return and could not be removed during analysis.Severe stretching, bunching, twisting and deformation was evident to catheter material around the electrodes.Twisting was evident to the material and thermocouple wires proximal to electrode 4.Severe bunching evident between electrodes 1 and 2 and distal to electrode 1.A tear was evident distal of electrode 2.No deformation was evident to the distal tip.No abnormalities were visible to the plug and pins.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
An attempt was made to use one symplicity spyral catheter during a renal denervation procedure.During the procedure one launcher guide catheter and one thunder guidewire were also used.It was reported that the spyral catheter became stuck in the non medtronic tuohy.It was detailed that the spyral catheter was unable to advance due to being caught in the non medtronic tuohy and it had to be removed.The issue occurred during first insertion into patient and the spyral catheter had been used to perform ablations/treatments prior to being getting caught in the tuohy.It was not possible to get the spyral catheter untangled from the tuohy while still inside the patient and was unable to preserve the spyral catheter to continue ablating with that specific catheter.The operator felt that the best decision to ensure patient safety was to remove spyral catheter from the patient¿s body.After both the tuohy and thespyral catheter were removed from the patient, the spyral catheter could be removed from the tuohy.There was damage noted to the spyral catheter while removing from the tuohy.The was no medical occurrence, disease or injury reported.The spyral catheter and tuohy were replaced in order to complete the procedure.There were no issues noted with the launcher guide catheter and the thunder guidewire used and they were used to complete the procedure.The non medtronic tuohy was reported to be able to accommodate devices up to a 7.3f size.There was no injury to the patient because of the event.

• 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: 19759915
• Report Number: 9612164-2024-03279
• Device Sequence Number: 12974430
• Product Code: QYI
• UDI-Device Identifier: 00763000354466
• UDI-Public: 00763000354466
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 07/17/2024

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: 05/09/2026
• Device Model Number: RDN016
• Device Catalogue Number: RDN016
• Device Lot Number: 0011770466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2023
• 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 Age: 50 YR
• Patient Sex: Male
• Patient Weight: 117 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White