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

Model Number	86248
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the foot switch of the maestro 4000 controller failed to halt radiofrequency (rf) delivery.During an ablation procedure to treat supraventricular tachycardia (svt), the foot pedal did not terminate ablation delivery after it was released.According to the physician, he was performing a second rf burn to the slow pathway of the atrioventricular (av) node.When he was finished ablating, he took his foot off the pedal only to find that the generator continued to deliver rf.The physician quickly withdrew the catheter away from the ablation site and a few seconds later the generator stopped delivering rf spontaneously.The procedure was completed and no complications occurred as a result of the issue.

• Brand Name: MAESTRO 4000 CONTROLLER
• Common Device Name: 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: 9224112
• Report Number: 2134265-2019-12822
• Device Sequence Number: 10860357
• Product Code: LPB
• UDI-Device Identifier: 08714729861911
• UDI-Public: 08714729861911
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P020025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/23/2019

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
• Operator of Device: Health Professional
• Device Model Number: 86248
• Device Catalogue Number: 86248
• Device Lot Number: 0020615026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z 0202 2019
• Patient Sequence Number: 1
• Patient Age: 45 YR