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

Model Number M005ATS25020

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Burn(s) (1757)

Event Date 10/28/2016

Event Type  Injury  

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(6).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

On (b)(6) 2016, the patient underwent the first bronchial thermoplasty treatment to the right lower lobe of the lungs.Additionally, it was reported that this was one of the first bronchial thermoplasty procedures performed by this hospital.On (b)(6) 2016, the physician received an in-service training on the use of the alair bronchial thermoplasty system.During the procedure, upon depressing the foot pedal to activate the alair bt catheter in segment 7 of the right lower lobe, the patient return electrode icon and the catheter electrode array icon on the alair bt controller lit amber.The physician continued to attempt to activate the alair bt catheter by depressing the foot pedal, but the patient return electrode icon and the catheter electrode array icon on the alair bt controller continued to light amber.The alair bt catheter was removed from the patient and was cleaned in room temperature saline water.The patient return electrode was removed from the patient and replaced with a new one.The alair bt catheter was disconnected from the controller and then reconnected, and the indicators on the controller were no longer lit.After approximately 40 successful activations, the physician activated the alair bt catheter in the carina of segment 7 in the right lower lobe of the lungs.According to the complainant, the physician reportedly saw smoke arising, although visibility was very bad.When the physician went closer to the point where the electrode array touched the airway wall, the physician could see a 'burnt spot'.The alair bt catheter was removed from the patient and cleaned with saline water at room temperature.The physician then reinserted the alair bt catheter and performed approximately 40 more activations to complete the bronchial thermoplasty treatment with no further issues.There was no treatment required for the burn, and the patient was reported to be stable following the bronchial thermoplasty treatment.The burn was potentially caused by a device malfunction, however, the exact malfunction of the alair bt catheter is unknown.

• Brand Name: ALAIR¿
• Type of Device: BRONCHIAL THERMOPLASTY SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6116896
• MDR Text Key: 60545304
• Report Number: 3005099803-2016-03679
• Device Sequence Number: 1
• Product Code: OOY
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M005ATS25020
• Device Catalogue Number: ATS 2-5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2016
• 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): Other