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

Model Number	M005ATS25010
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Burn(s) (1757); Necrosis (1971); Pain (1994); Respiratory Insufficiency (4462); Swelling/ Edema (4577)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf patient code e1704 captures the reportable event of burns.Imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e0743 captures the reportable event of respiratory distress.Imdrf patient code e2338 captures the reportable event of edema.Imdrf patient code e2327 captures the reportable event of necrosis.Imdrf impact code f08 captures the reportable event of hospitalization.
Event or Problem Description
It was reported to boston scientific corporation that a bt catheter was used during a bronchial thermoplasty procedure performed on (b)(6) 2023.After the procedure, of a third application when the patient returned home, the patient felt more pain and she had more difficulty breathing.She felt the need to consult the emergency room.After the first endoscopy examination, edema, necrosis, and a serious burn was observed in the bronchi.It was reported that debridement was used to put out some black tissue that burned.The patient was admitted to the hospital.

• Brand Name: ALAIR
• 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; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17070453
• Report Number: 3005099803-2023-02854
• Device Sequence Number: 5886340
• Product Code: OOY
• UDI-Device Identifier: 08714729802792
• UDI-Public: 08714729802792
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/21/2024
• Device Model Number: M005ATS25010
• Device Catalogue Number: ATS 2-5
• Device Lot Number: 0030704260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown