MAUDE Adverse Event Report: ST. JUDE MEDICAL DISPOSABLE SIMPLICITY ELECTRODE; PROBE, RADIOFREQUENCY LESION

Model Number	RFDE-SI
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	09/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During a sacral radiofrequency ablation procedure, the probe fractured and separated in the patient.An 18g needle was used to turn the broken probe and the broken probe was removed.The probe was replaced and the procedure was completed with no adverse patient consequences.
Additional Manufacturer Narrative
One simplicity radiofrequency electrode was received for evaluation.  a kink was noted distal to the fractured part of the probe.The probe was fractured and detached from the connector.The ifu states, ¿do not bend or reshape the electrode; this can cause permanent mechanical damage.¿ the device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with specifications and procedures.The cause of the fracture in the probe and the kink in the shaft is consistent with incorrect use of the device.

• Brand Name: DISPOSABLE SIMPLICITY ELECTRODE
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 12569088
• Report Number: 2182269-2021-00071
• Device Sequence Number: 19841563
• Product Code: GXI
• UDI-Device Identifier: 05415067028976
• UDI-Public: 05415067028976
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K011387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2021

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: 11/30/2022
• Device Model Number: RFDE-SI
• Device Catalogue Number: RFDE-SIRFDE-SI
• Device Lot Number: 7317003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention