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

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

Patient Problem Hypoxia (1918)

Event Date 03/01/2012

Event Type  Injury  

Manufacturer Narrative

(b)(6).The complainant was unable to provide the upn and lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.Study source - (b)(6) study.(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) 2012 as part of the alair pas2 clinical study.On (b)(6) 2012 the patient underwent the second bronchial thermoplasty procedure performed in the left lower lobe of the lungs.No issues noted with the device.According to the complainant, post procedure, the nurse noted that the patient's peripheral capillary oxygen saturation (spo2) "deacreased" to 89% while sleeping.Oxygen was administered to the patient while sleeping via nasal cannula at two liters per minute.The oxygen was administered until the patient was awake and ready for discharge.The event was resolved and the patient was not hospitalized due to this event.

• Brand Name: ALAIR
• Type of Device: BRONCHIAL THERMOPLASTY SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9868279
• MDR Text Key: 189608943
• Report Number: 3005099803-2020-01217
• Device Sequence Number: 1
• Product Code: OOY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2020
• 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): Required Intervention
• Patient Age: 54 YR