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 Problem Asthma (1726)

Event Date 09/20/2017

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Study source - (b)(6).Problem code 1726 captures the reportable event of exacerbation of asthma requiring hospitalization.According to the complainant, the suspect device is not available for return.If any further relevant information is received, a supplemental mdr 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) 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 first bronchial thermoplasty procedure performed in the right lower lobe of the lungs.No issues noted with the device.On (b)(6) 2017 the patient was discharged from the hospital following the bronchial thermoplasty treatment.According to the complainant, on (b)(6) 2017 the patient experienced asthma exacerbation and was treated with systemic steroids.The patient was hospitalized due to this event.On (b)(6) 2017 the patient recovered from the asthma exacerbation and was discharged from the hospital.

• 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: 8470352
• MDR Text Key: 140511620
• Report Number: 3005099803-2019-01571
• Device Sequence Number: 1
• Product Code: OOY
• UDI-Device Identifier: 08714729802792
• UDI-Public: 08714729802792
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/01/2019

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: 03/05/2019
• Initial Date FDA Received: 04/01/2019
• 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
• Patient Age: 47 YR
• Patient Weight: 55