MAUDE Adverse Event Report: ALAIR; BRONCHIAL THERMOPLASTY SYSTEM

Model Number	M005ATS25010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter's address is (b)(6).Investigation results: an alair bt catheter was received for analysis.Visual inspection of the returned device revealed that one electrode in the array was found broken.Additionally, the yellow tc wire was found detached from the solder pads due to the device condition.However, during microscopic inspection, the red wire was found correctly soldered to the solder pads.It was unable to confirm the reported event of shaft break since the shaft was not broken upon return.No other issues were noted.Based on the event description, the problem was noticed during procedure and inside the patient.These types of failures encountered were consistent with the application of excessive force during usage.This may be related to some factors such as handling of the device, the technique used by the physician and normal procedural difficulties encountered during the procedure.These factors could have possibly affected the device performance and its integrity contributing to the failure experienced by the customer.Based on the information available and the analysis performed, the most probable root cause classification is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
It was reported to boston scientific corporation that an alair bronchial thermoplasty (bt) catheter was used during a bronchial thermoplasty procedure performed in the bronchus on (b)(6) 2019.According to the complainant, during procedure, the distal tip of the catheter fractured after the catheter was placed.Reportedly, no part of the catheter detached or was separated.The device was removed and the procedure was completed with another alair bt catheter.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that one electrode in the array was found broken.

• Brand Name: ALAIR
• Common Device Name: BRONCHIAL THERMOPLASTY SYSTEM
• MDR Report Key: 9836282
• Report Number: 3005099803-2020-01000
• Device Sequence Number: 11087620
• Product Code: OOY
• UDI-Device Identifier: 08714729802792
• UDI-Public: 08714729802792
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P080032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/15/2019
• Device Model Number: M005ATS25010
• Device Catalogue Number: ATS 2-5
• Device Lot Number: 0021517897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/16/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 68