MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALAIR BRONCHIAL THERMOPLASTY RF CONTROLLER; BRONCHIAL THERMOPLASTY SYSTEM

Model Number	M005ATS20000
Medical Device Problem Codes	Device Alarm System (1012); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-04602 and 3005099803-2022-04603 for the associated device information.It was reported to boston scientific corporation that an alair bt catheter was used for severe asthma during a bronchial thermoplasty procedure performed on (b)(6) 2022.During the procedure, two catheters and three grounding pads were used.An error on the controller showed a problem with the grounding pad and catheter.The physician was able to confirm that the grounding pads were placed correctly and was making contact with the airway wall.The physician replaced the grounding pad and catheter but the same problem occurred.They tested the controller with multiple demo catheters and received the same error.The procedure was cancelled due to this event.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
The complainant was unable to provide the upn and lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the upn and lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.Block h6: impact code f1001 is being used to capture the reportable problem of aborted/cancelled procedure.Block h11: block b5 has been updated based on additional information received august 26, 2022.
Event or Problem Description
Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-04602, 3005099803-2022-04603 and 3005099803-2022-04673 for the associated device information.It was reported to boston scientific corporation that an alair bt catheter was used for severe asthma during a bronchial thermoplasty procedure performed on (b)(6) 2022.During the procedure, two catheters and three grounding pads were used.An error on the controller showed a problem with the grounding pad and catheter.The physician was able to confirm that the grounding pads were placed correctly and was making contact with the airway wall.The physician replaced the grounding pad and catheter but the same problem occurred.They tested the controller with multiple demo catheters and received the same error.The procedure was cancelled due to this event.There were no patient complications reported as a result of this event.***additional information received on august 26, 2022*** it was reported that the two bt catheters and one bt controller were used in the right lower lobe of the lungs during the first bronchial thermoplasty procedure.From the way it was described, the catheter basket was illuminating orange on the controller and the grounding pad icon was able to connect just fine and was well after three missed activations.Then, the physician was able to complete the procedure on august 16, 2022.

• Brand Name: ALAIR BRONCHIAL THERMOPLASTY RF CONTROLLER
• Common Device Name: BRONCHIAL THERMOPLASTY SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15243069
• Report Number: 3005099803-2022-04673
• Device Sequence Number: 4572339
• Product Code: OOY
• UDI-Device Identifier: 08714729796695
• UDI-Public: 08714729796695
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P080032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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: M005ATS20000
• Device Catalogue Number: ATS 200
• Device Lot Number: 051205-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown