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

Model Number	M005ATS25010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Asthma (1726)
Date of Event	08/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The clinical patient id is (b)(6).The patient's date of birth is (b)(6) 1966.The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.However, the complainant stated that the device was used prior to the expiration date.(b)(6).(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an alair bronchial thermoplasty (bt) catheter was used during a bronchial thermoplasty procedure performed on (b)(6) 2018 as part of the (b)(6) clinical study.This complaint is being reported based on the event of asthma requiring hospitalization.On (b)(6) 2018 the patient was admitted to the hospital as planned by the physician for the bronchial thermoplasty treatment.On (b)(6) 2018 the patient underwent the second bronchial thermoplasty procedure performed in the left lower lobe of the lungs.No issues noted with the device.On (b)(6) 2018 the patient was discharged from the hospital following the bronchial thermoplasty treatment.According to the complainant, on (b)(6) 2018 the patient developed asthma that was treated with systemic steroids.It was necessary to hospitalize the patient due to this event.The exact dates the patient was hospitalized and discharged were not reported.On (b)(6) 2018 the patient recovered from asthma.

• Brand Name: ALAIR
• Common Device Name: BRONCHIAL THERMOPLASTY SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9118546
• Report Number: 3005099803-2019-04462
• Device Sequence Number: 19282895
• Product Code: OOY
• UDI-Device Identifier: 08714729802792
• UDI-Public: 08714729802792
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P080032
• 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): 09/25/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: M005ATS25010
• Device Catalogue Number: ATS 2-5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2019
• Initial Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Weight: 70