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 Respiratory Distress (2045)

Event Date 01/12/2017

Event Type  Injury  

Manufacturer Narrative

The patient's exact date of birth was not reported, however, it was reported that the patient was born in (b)(6).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).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) 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 procedure.On (b)(6) 2017 the patient underwent the second bronchial thermoplasty procedure performed in the left lower lobe of the lungs.No issues were noted with the device.According to the complainant, on (b)(6) 2017 the patient developed atelectasis requiring hospitalization to be extended.The patient was treated with systemic steroids.On (b)(6) 2017 the atelectasis was in remission and the patient was discharged from the hospital.

• Brand Name: ALAIR
• Type of Device: BRONCHIAL THERMOPLASTY SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road,; cork ; EI
• Manufacturer Contact: carole morley ; 100 boston scientific way; marlborough, MA 01752-1242 ; 5086834015
• MDR Report Key: 7878017
• MDR Text Key: 120321181
• Report Number: 3005099803-2018-60387
• 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: 09/14/2018

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: Health Professional
• Device Model Number: M005ATS25010
• Device Catalogue Number: 60073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2018
• Initial Date FDA Received: 09/14/2018
• 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 Weight: 62