MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK ALAIR¿; BRONCHIAL THERMOPLASTY SYSTEM

Model Number M005ATS25010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Chest Pain (1776)

Event Date 08/09/2017

Event Type  Injury  

Manufacturer Narrative

The exact age of the patient was not reported.However, the patient was reported to be over the age of 18 years old.The reported lot number could not be matched to the reported device.Therefore, the lot expiration and device manufacture dates are unknown at this time.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.On (b)(6) 2017 the patient underwent the third bronchial thermoplasty treatment performed in the upper lobes of the lungs.During the procedure, the alair bt catheter experienced 4 incomplete activations.There were no physical defects noted with the device, and the procedure was completed with this catheter.According to the complainant, the patient experienced cough during the procedure requiring the physician to discontinue the bt treatment.Additionally, the patient experienced chest pain.The patient was administered analgesic 'calonal' for treatment and the hospitalization was extended to 16 days.The patient continues to experience chest pain one or two times a day since the third bt treatment.In the physician's assessment, the adverse event was related to the bt treatment, however, the root cause of the chest pain is unspecified at this time.Additionally, the physician noted that the event may be a 'psychological effect, because there is a psychogenic asthma.' treatment will be planned with the physician in cardiovascular internal medicine.

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.On (b)(6) 2017 the patient underwent the third bronchial thermoplasty treatment performed in the upper lobes of the lungs.During the procedure, the alair bt catheter experienced 4 incomplete activations.There were no physical defects noted with the device, and the procedure was completed with this catheter.According to the complainant, the patient experienced cough during the procedure requiring the physician to discontinue the bt treatment.Additionally, the patient experienced chest pain.The patient was administered analgesic 'calonal' for treatment and the hospitalization was extended to 16 days.The patient continues to experience chest pain one or two times a day since the third bt treatment.In the physician's assessment, the adverse event was related to the bt treatment, however, the root cause of the chest pain is unspecified at this time.Additionally, the physician noted that the event may be a 'psychological effect, because there is a psychogenic asthma.' treatment will be planned with the physician in cardiovascular internal medicine.

Manufacturer Narrative

Device lot number reported, device expiration date updated, device manufactured date updated.

• Brand Name: ALAIR¿
• Type of Device: BRONCHIAL THERMOPLASTY SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• MDR Report Key: 7468024
• MDR Text Key: 106715275
• Report Number: 3005099803-2018-01178
• Device Sequence Number: 1
• Product Code: OOY
• UDI-Device Identifier: 08714729802792
• UDI-Public: 08714729802792
• Combination Product (y/n): N
• PMA/PMN Number: P080032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/01/2018

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 Expiration Date: 04/25/2019
• Device Model Number: M005ATS25010
• Device Catalogue Number: ATS 2-5
• Device Lot Number: 0020563251
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2018
• Initial Date FDA Received: 04/27/2018
• Supplement Dates Manufacturer Received: 05/01/2018
• Supplement Dates FDA Received: 05/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization