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

Model Number 86250

Device Problem Device Remains Activated (1525)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2019

Event Type  malfunction  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that there was a failure to halt radio frequency (rf) ablation.During an ablation procedure, when the physician came off ablation with the maestro foot switch, the generator continued to deliver rf and continued making the sound of rf.The physician double tapped the foot pedal to come off ablation.No patient injury occurred and the case was completed successfully with no other issues.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that there was a failure to halt radio frequency (rf) ablation.During an ablation procedure, when the physician came off ablation with the maestro foot switch, the generator continued to deliver rf and continued making the sound of rf.The physician double tapped the foot pedal to come off ablation.No patient injury occurred and the case was completed successfully with no other issues.It was further reported that the procedure was to treat atrial fibrillation.

• Brand Name: MAESTRO FOOT SWITCH
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8983124
• MDR Text Key: 157154578
• Report Number: 2134265-2019-10947
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• PMA/PMN Number: P020025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/07/2019

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
• Device Operator: Health Professional
• Device Model Number: 86250
• Device Catalogue Number: 86250
• Device Lot Number: 0355293002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 09/10/2019
• Supplement Dates Manufacturer Received: 09/10/2019
• Supplement Dates FDA Received: 10/07/2019
• Patient Sequence Number: 1