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

Model Number M005ATS25020

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

Patient Problems Asthma (1726); Respiratory Tract Infection (2420); No Code Available (3191)

Event Date 02/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).Study source: e7086 bsc bt registry.The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, 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 bt procedure performed on (b)(6) 2016 as part of the bsc (b)(6) study.On (b)(6) 2016 the patient was admitted for the bt procedure as planned by the physician.On (b)(6) 2016 the patient underwent the first bt treatment to the right lower lobe of the lungs.No issues were noted with the device.According to the complainant, on (b)(6) 2016, while hospitalized for observation following the bt procedure, the patient experienced post-procedure bronchospasm, cough, and whitish expectoration.The patient was treated with prednisone and was discharged from the hospital on (b)(6) 2016 as planned by the physician for prophylactic reasons.On (b)(6) 2016 the patient experienced upper respiratory tract infection (urti) and was treated with medication (exact type not reported).No hospitalizations or er visits occurred due to this event.On (b)(6) 2016 the urti had resolved.Baseline spirometry values visit date: (b)(6) 2016: pre-bronchodilator, fev1: 2.64, fev1 % predicted: 66.10, fvc: 4.01, fvc % predicted: 83.50.Post-bronchodilator: fev1: 3.71, fev1 % predicted: 93.10, fvc: 5.04, fvc % predicted: 105.00.

Manufacturer Narrative

Study source: (b)(6).(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Updated based on additional information received on september 16, 2019.

Event Description

It was reported to boston scientific corporation that an alair bronchial thermoplasty (bt) catheter was used during a bt procedure performed on (b)(6) 2016 as part of the (b)(6) study.On (b)(6) 2016 the patient was admitted for the bt procedure as planned by the physician.On (b)(6) 2016 the patient underwent the first bt treatment to the right lower lobe of the lungs.No issues were noted with the device.According to the complainant, on (b)(6) 2016, while hospitalized for observation following the bt procedure, the patient experienced post-procedure bronchospasm, cough, and whitish expectoration.The patient was treated with prednisone and was discharged from the hospital on (b)(6) 2016 as planned by the physician for prophylactic reasons.On (b)(6) 2016 the patient experienced upper respiratory tract infection (urti) and was treated with medication (exact type not reported).No hospitalizations or emergency room visits occurred due to this event.On (b)(6) 2016 the urti had resolved.Baseline spirometry values: visit date: (b)(6) 2016, (b)(6).

• Brand Name: ALAIR
• Type of Device: BRONCHIAL THERMOPLASTY SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; model farm road; marlborough MA 01752
• MDR Report Key: 6848247
• MDR Text Key: 85123324
• Report Number: 3005099803-2017-02742
• Device Sequence Number: 1
• Product Code: OOY
• Combination Product (y/n): N
• PMA/PMN Number: P080032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

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 Expiration Date: 05/31/2017
• Device Model Number: M005ATS25020
• Device Catalogue Number: ATS 2-5
• Device Lot Number: 0017994933
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/11/2017
• Initial Date FDA Received: 09/07/2017
• Supplement Dates Manufacturer Received: 09/16/2019
• Supplement Dates FDA Received: 10/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2015
• 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): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 114