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 Dyspnea (1816)

Event Date 05/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.However, the complainant stated that the device was used prior to the expiration date.(b)(6).(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) 2018 as part of the (b)(6) clinical study.This complaint is being reported based on the event of breathing difficulty (dyspnea) requiring unknown medication to treat and hospitalization.On (b)(6) 2018 the patient was admitted to the hospital as planned by the physician for the bronchial thermoplasty treatment.On (b)(6) 2018 the patient underwent the second bronchial thermoplasty procedure performed in the left lower lobe of the lungs.No issues noted with the device.On (b)(6) 2018 the patient was discharged from the hospital following the bronchial thermoplasty treatment.According to the complainant, on (b)(6) 2018 the patient experienced breathing difficulty and was presented to the emergency room (er).The patient was treated with systemic steroids and an additional medication.The exact type of medication administered or increased to treat the patient's breathing difficulty was not reported.It was necessary to hospitalize the patient due to this event.The exact dates the patient was hospitalized and discharged were not reported.On (b)(6) 2018 the patient recovered from breathing difficulty.According to the complainant, on (b)(6) 2018 the patient experienced breathing difficulty and was presented to the emergency room (er).The patient was treated with systemic steroids and an additional medication.The exact type of medication administered or increased to treat the patient's breathing difficulty was not reported.It was necessary to hospitalize the patient due to this event.The exact dates the patient was hospitalized and discharged were not reported.On (b)(6) 2018 the patient recovered from breathing difficulty.

• 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: 9119936
• MDR Text Key: 160350817
• Report Number: 3005099803-2019-04479
• 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: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• 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
• Date Manufacturer Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 80