MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAESTRO FOOT SWITCH; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	86250
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that radiofrequency (rf) ablation was not halted after the physician removed his foot from the foot switch.During a slow pathway atrioventricular (av) node modification ablation procedure to treat av-nodal reentrant tachycardia a maestro 4000 system was used.The physician proceeded to ablate using the foot switch, after successfully completing the first ablation lesion, when he removed his foot from the foot switch, rf energy continued to be delivered to the patient.The ablation catheter was pulled into the sheath and away from the treatment area.The foot switch was disconnected and the procedure was completed by controlling the ablation via the on/off switch on the maestro generator.No patient complications were reported and the patient's current condition is fine.
Event or Problem Description
It was reported that radiofrequency (rf) ablation was not halted after the physician removed his foot from the foot switch.During a slow pathway atrioventricular (av) node modification ablation procedure to treat av-nodal reentrant tachycardia a maestro 4000 system was used.The physician proceeded to ablate using the foot switch, after successfully completing the first ablation lesion, when he removed his foot from the foot switch, rf energy continued to be delivered to the patient.The ablation catheter was pulled into the sheath and away from the treatment area.The foot switch was disconnected and the procedure was completed by controlling the ablation via the on/off switch on the maestro generator.No patient complications were reported and the patient's current condition is fine.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.The footswitch was returned to boston scientific for analysis.Visual inspection did not find any physical damage.The device connected to an ohm meter and all pins were working properly when the footswitch was activated.The switch was powered on and off with no issues.The device passed all electrical and mechanical testing.The review of the device history review(dhr) and service records did not identify any issue that could be related to the reported event.Based on the available information, boston scientific's investigation findings were unable to establish a clear conclusion about the cause of the reported event.The reported observations were not replicated during device analysis.The device met all requirements prior to being approved for final distribution/sale and there was no evidence to suggest that the instructions for use (ifu) was not followed.

• Brand Name: MAESTRO FOOT SWITCH
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9652808
• Report Number: 2134265-2020-00792
• Device Sequence Number: 2422684
• Product Code: OAD
• UDI-Device Identifier: 08714729862437
• UDI-Public: 08714729862437
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P020025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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 Model Number: 86250
• Device Catalogue Number: 86250
• Device Lot Number: 0355292029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1