MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAESTRO 4000 CONTROLLER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number 86248

Device Problem Device Remains Activated (1525)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2019

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 the foot pedal failed to halt radiofrequency (rf) delivery.During an ablation procedure, the physician removed his foot from the foot pedal of the maestro 4000 generator and the ablation did not stop.This happened twice: the first time, the ablation continued for 3 seconds before stopping, and the second time, the ablation was stopped manually after the foot pedal was released.There were no patient complications and the procedure was completed successfully.

Manufacturer Narrative

Visual inspection of the retuned device showed no visual damage to the device during incoming service inspection.Tamper proof seal was present but broken.The returned device passed power-on self-test and all performance criteria of the final test procedure.The complaint of unable to halt ablation was not confirmed.

Event Description

It was reported that the foot pedal failed to halt radiofrequency (rf) delivery.During an ablation procedure, the physician removed his foot from the foot pedal of the maestro 4000 generator and the ablation did not stop.This happened twice: the first time, the ablation continued for 3 seconds before stopping, and the second time, the ablation was stopped manually after the foot pedal was released.There were no patient complications and the procedure was completed successfully.

• Brand Name: MAESTRO 4000 CONTROLLER
• Type of Device: 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: 9203472
• MDR Text Key: 165327667
• Report Number: 2134265-2019-12628
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 08714729861911
• UDI-Public: 08714729861911
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 86248
• Device Catalogue Number: 86248
• Device Lot Number: 1109160354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0202-2019
• Patient Sequence Number: 1