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

Model Number M005ATS25010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Bronchospasm (2598)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.(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 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) 2019.On (b)(6) 2019 the patient underwent the third bronchial thermoplasty procedure performed in the right upper lobe of the lungs.There were no issues noted with the device.According to the complainant, on (b)(6) 2019, the patient had a chest x-ray performed, showing right upper lobe pneumonitis.Additionally, the physician thought the patient had bronchospasms.The patient was admitted to the hospital for this event.However, there were no additional treatment required for the patient's pneumonitis and bronchospasm, just observation.On (b)(6) 2019, the patient was discharged from the hospital in stable condition.

• Brand Name: ALAIR
• Type of Device: BRONCHIAL THERMOPLASTY SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8549495
• MDR Text Key: 143068181
• Report Number: 3005099803-2019-02071
• Device Sequence Number: 1
• Product Code: OOY
• UDI-Device Identifier: 08714729802792
• UDI-Public: 08714729802792
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2019

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
• Device Operator: Health Professional
• Device Model Number: M005ATS25010
• Device Catalogue Number: ATS 2-5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization