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 Codes	Asthma (1726); Pneumonia (2011)
Date of Event	06/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).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) 2017 as part of the (b)(6) clinical study.On (b)(6) 2017 the patient was admitted to the hospital as planned by the physician for the bronchial thermoplasty treatment.On (b)(6) 2017 the patient underwent the first bronchial thermoplasty procedure performed in the right lower lobe of the lungs.No issues noted with the device.According to the complainant, on (b)(6) 2017 the patient developed asthma that was treated with steroids and an additional medication.The exact type of drug that was administered or increased to treat the patient's asthma was not reported.It was necessary to extend the patient's hospitalization due to this event.On (b)(6) 2017 the patient recovered from asthma.On (b)(6) 2017 the patient developed bacterial pneumonia that was treated with an unknown additional medication.The exact type of drug that was administered or increased to treat the patient's bacterial pneumonia was not reported.It was necessary to extend the patient's hospitalization due to this event.On (b)(6) 2017 the patient recovered from bacterial pneumonia.On (b)(6) 2017 the patient was discharged from the hospital.

• 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: 8946145
• Report Number: 3005099803-2019-04227
• Device Sequence Number: 19444094
• 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): 08/29/2019

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: 08/13/2019
• Initial Report FDA Received Date: 08/29/2019
• 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; Required Intervention
• Patient Weight: 55