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); Bronchitis (1752); Unspecified Infection (1930); Pneumonia (2011); No Code Available (3191)
Date of Event	09/06/2017
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 third bronchial thermoplasty procedure performed in the right/left upper lobe of the lungs.No issues noted with the device.According to the complainant, on (b)(6) 2017 the patient developed bacterial pneumonia and was administered or increased with a drug to treat the bacterial pneumonia.The exact type of medication administered or increased 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.On (b)(6) 2017 the patient developed bronchitis and was administered or increased with a drug to treat the bronchitis.The exact type of medication administered or increased was not reported.It was necessary hospitalize the patient due to this event.On (b)(6) 2017 the patient recovered from bronchitis.However, the exact date the patient was discharged from the hospital was not reported.On (b)(6) 2017 the patient developed asthma and was presented to the emergency room (er).The patient was treated with systemic steroids and it was not necessary hospitalize the patient due to this event.The patient recovered from asthma on the same date.On (b)(6) 2017 the patient also developed shingles and was administered or increased with a drug to treat the shingles.The exact type of medication administered or increased was not reported.It was not necessary hospitalize the patient due to this event.On (b)(6) 2018 the patient recovered from shingles.On (b)(6) 2018 the patient developed bronchitis and was administered or increased with a drug to treat the bronchitis.The exact type of medication administered or increased was not reported.It was not necessary hospitalize the patient due to this event.On (b)(6) 2018 the patient recovered from bronchitis.On (b)(6) 2018 the patient developed lung abscess and was presented to the emergency room (er).The patient was administered or increased with a drug to treat the lung abscess.The exact type of medication administered or increased was not reported.It was necessary hospitalize the patient due to this event.On (b)(6) 2018 the patient recovered from the lung abscess.However, the exact date the patient was discharged from the hospital was not reported.In the physician's assessment, the adverse events of bronchitis occurring on (b)(6) 2017 and (b)(6) 2018, asthma occurring on (b)(6) 2017, shingles occurring on (b)(6) 2017, and lung abscess occurring on (b)(6) 2018 are not related to the alair bt procedure or devices.

• 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: 9098966
• Report Number: 3005099803-2019-04328
• Device Sequence Number: 2700146
• 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): 09/20/2019

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: 08/27/2019
• Initial Report FDA Received Date: 09/20/2019
• 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 Age: 75 YR
• Patient Weight: 70