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); Hemoptysis (1887); Pneumothorax (2012); Respiratory Distress (2045)

Event Date 02/15/2017

Event Type  Injury  

Manufacturer Narrative

The clinical patient id is (b)(6).The patient's date of birth is (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) 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 third bronchial thermoplasty procedure performed in the right/left upper lobe of the lungs.No issues noted with the device.According to the complainant, on (b)(6) 2017 the patient experienced hemoptysis (coughing up blood).No treatment was given for the patient's hemoptysis.On the same date, the patient developed pulmonary atelectasis that was treated with systemic steroids.It was necessary to extend the patient's hospitalization.On (b)(6) 2017 the patient developed aerothorax.Treatment was done for the patient's aerothorax, however, the exact type of treatment was not reported.On (b)(6) 2017 the patient recovered from the pulmonary atelectasis and the patient's hemoptysis resolved on its own.The patient also recovered from the aerothorax on the same date.On (b)(6) 2017 the patient was discharged from the hospital.On (b)(6) 2017 the patient experienced asthma that was treated with systemic steroids requiring hospitalization.The exact dates the patient was admitted to the hospital and was discharged were not reported.However, the patient recovered from asthma on (b)(6) 2018.On (b)(6) 2018 the patient experienced asthma that was treated with systemic steroids.It was not necessary to hospitalize the patient due to this event.On (b)(6) 2018 the patient recovered from the asthma.On (b)(6) 2018 a patient's follow up for one year post procedure was performed.It was reported that the patient still developed asthma more than once per week that was treated with systemic steroids and additional medication.The exact type of medication administered was not reported.It was not necessary to hospitalize the patient due to this event.Reportedly, the patient has not recovered from asthma.

• 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: 8939544
• MDR Text Key: 158873979
• Report Number: 3005099803-2019-04254
• 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: 08/28/2019

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: 08/08/2019
• Initial Date FDA Received: 08/28/2019
• 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; Required Intervention
• Patient Weight: 85