MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK ALAIR¿; BRONCHIAL THERMOPLASTY SYSTEM

Model Number M005ATS25020

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

Patient Problem Bronchospasm (2598)

Event Date 01/14/2015

Event Type  Injury  

Manufacturer Narrative

The exact age of the patient was not reported, however, the patient was over the age of 18 years old.Study source - (b)(6).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 bronchial thermoplasty procedure performed on (b)(6) 2015 as part of the (b)(6) study.This complaint is being reported based on the event of bronchospasm requiring treatment with antibiotics.On (b)(6) 2015 the patient underwent the third bronchial thermoplasty procedure performed in the right and left upper lobes of the lungs.No issues were noted with the device.According to the complainant, following the procedure, the patient experienced bronchospasm and was treated with was treated with urbason and levofloxacine.Hospitalization was not prolonged due to the event.On (b)(6) 2015 the event resolved.On (b)(6) 2015 the patient was discharged from the hospital.Baseline spirometry values visit date: (b)(6) 2014.Pre-bronchodilator: fev1: 1.12, fev1 % predicted: 59.00, fvc: 1.83, fvc % predicted: 71.00.Post-bronchodilator: fev1: 1.32, fev1 % predicted: 69.00, fvc: 2.12, fvc % 82.00, lab data: n/a.

• Brand Name: ALAIR¿
• Type of Device: BRONCHIAL THERMOPLASTY SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7315181
• MDR Text Key: 101560965
• Report Number: 3005099803-2018-00498
• Device Sequence Number: 1
• Product Code: OOY
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: P080032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2018

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: Physician
• Device Expiration Date: 04/30/2016
• Device Model Number: M005ATS25020
• Device Catalogue Number: ATS 2-5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2014
• 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 Weight: 62