MAUDE Adverse Event Report: MINTA MEDICAL LIMITED REUSABLE ELECTRODE, 10CM, NITINOL; PROBE, RADIOFREQUENCY LESION

Model Number	RF-NE-10
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During a radiofrequency ablation procedure, the probe did not reach the appropriate therapy temperature and the procedure was cancelled.There were no adverse consequences to the patient due to the cancellation.
Additional Manufacturer Narrative
One 10 cm, nitinol reusable rf thermocouple electrode was received for evaluation.An error message was noted on the generator when the electrode was connected and no temperature was displayed.Electrical testing revealed an open circuit between the thermocouple wires.The source of the open circuit was isolated to within the hub and nitinol tubing assembly.The device was manufactured according to specifications as supported by the receiving inspection results.The cause of the open circuit remains unknown.

• Brand Name: REUSABLE ELECTRODE, 10CM, NITINOL
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): MINTA MEDICAL LIMITED; caddick road; merseyside knowsley L34 9 HP; UK L34 9HP
• MDR Report Key: 10871644
• Report Number: 3004617090-2020-00005
• Device Sequence Number: 2635822
• Product Code: GXI
• UDI-Device Identifier: 05415067025180
• UDI-Public: 05415067025180
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K090608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2020

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: RF-NE-10
• Device Catalogue Number: RF-NE-10
• Device Lot Number: M15958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 12/07/2020
• 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: Other