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 Asthma (1726); Fever (1858); Headache (1880); Pain (1994); Discomfort (2330); Respiratory Tract Infection (2420)

Event Date 05/05/2014

Event Type  Injury  

Manufacturer Narrative

The clinical patient id is (b)(6).The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.However, the complainant stated that the device was used prior to the expiration date.Study source: (b)(6) study.(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) 2014 as part of the (b)(6) study.On (b)(6) 2014, 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) 2014, the patient experienced fever of >38 degrees celsius with symptoms of shaking chills and sweats following the bronchial thermoplasty treatment and was treated with tylenol.On (b)(6) 2014, the patient experienced asthma exacerbation with symptoms of wheezing and coughing and was treated with prednisone.On (b)(6) 2014, the patient experienced upper respiratory tract infection.The event was reported to be continuing, however, no intervention was needed.Additionally, the patient's fever resolved.On (b)(6) 2014, the patient recovered from the asthma exacerbation.No hospitalizations or emergency room visits occurred as a result of these events.

• 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: 8846548
• MDR Text Key: 152804491
• Report Number: 3005099803-2019-03620
• 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: 07/31/2019

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: 07/10/2019
• Initial Date FDA Received: 07/31/2019
• 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): Other
• Patient Age: 25 YR
• Patient Weight: 86