MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALAIR; BRONCHIAL THERMOPLASTY SYSTEM

Model Number M005ATS25020

Device Problems Material Deformation (2976); Activation Problem (4042)

Patient Problem Hypoxia (1918)

Event Date 06/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).According to the complainant, the suspect device was contaminated and has been disposed, therefore it 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) 2019.On (b)(6) 2019, the patient underwent the second bronchial thermoplasty procedure performed in the superior right lower lobe bronchus (rb6) of the lungs.According to the complainant, during the procedure, when the product was opened and inserted into the patient, the catheter experienced several incomplete activations and the catheter handle icon flashed red on the alair bt controller.The catheter was removed and reportedly, the catheter had two areas of noticeable kinks.They tried to straighten the kinked part but it still did not work.There were no spare catheters so the procedure had to be abandoned.Reportedly, the patient experienced desaturation from the procedure.In the physician's assessment, the patient's condition following the procedure was not directly as a result of the faulty catheter.Reportedly, the patient needed to be intubated and recovered in intensive care unit.The bt procedure was rescheduled for (b)(6) 2019.

• 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: 8828309
• MDR Text Key: 152321673
• Report Number: 3005099803-2019-03704
• Device Sequence Number: 1
• Product Code: OOY
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Model Number: M005ATS25020
• Device Catalogue Number: ATS 2-5
• Device Lot Number: 0022883816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2018
• 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): Required Intervention