MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAESTRO 3000 CARDIAC ABLATION SYSTEM - FOOT SWITCH; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number 86250

Device Problems Device Remains Activated (1525); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2019

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 ablation could not be halted.During an ablation procedure for atrial fibrillation/atrial flutter, the maestro 4000 did not stop ablating when coming off the foot switch.The button on the console was used to halt ablation.The procedure was completed with no serious injuries or adverse patient effects.

• Brand Name: MAESTRO 3000 CARDIAC ABLATION SYSTEM - 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
• Manufacturer (Section G): LINEMASTER SWITCH CORPORATION; 29 plaine hill road; woodstock CT 06281
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 9495234
• MDR Text Key: 176764823
• Report Number: 2134265-2019-15989
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1