MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ALAIR¿; BRONCHIAL THERMOPLASTY SYSTEM

Model Number M005ATS25010

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

Patient Problem No Code Available (3191)

Event Date 02/23/2018

Event Type  Injury  

Manufacturer Narrative

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.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 treatment performed a part of the (b)(6) clinical study.On (b)(6) 2018 the patient underwent the third bronchial thermoplasty procedure performed in the right and left upper lobes of the lungs.No issues were noted with the device.According to the complainant, on (b)(6) 2018 the patient developed atelectasis requiring hospitalization to be extended.The patient was administered systemic steroids to treat the atelectasis.On (b)(6) 2018 the patient recovered from the event and was discharged from the hospital.

• Brand Name: ALAIR¿
• Type of Device: BRONCHIAL THERMOPLASTY SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7613771
• MDR Text Key: 111472288
• Report Number: 3005099803-2018-01842
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2018

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 Model Number: M005ATS25010
• Device Catalogue Number: ATS 2-5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 06/19/2018
• 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): Hospitalization
• Patient Age: 71 YR