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 03/14/2018

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.Atelectasis, study source- e7088 alair japan pms.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 procedure performed as part of the e7088 alair japan pms clinical study.This complaint is being reported based on the event of atelectasis requiring treatment with antibiotics.On (b)(6) 2018 the patient underwent the third bronchial thermoplasty treatment performed on 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 a 'small atelectasis' at the lingual segment of the lungs.Amoxicillin / clavulanate(ampc/cva) was prescribed.As of (b)(6) 2018 the event was resolved with no further patient complications reported.The patient's current condition is stable and the patient is expected to visit the facility on june 15, 2018 for followup.In the physician's assessment, it is unknown if the atelectasis was related to the bronchial thermoplasty treatement.

Event Description

It was reported to boston scientific corporation that an alair bronchial thermoplasty (bt) catheter was used during a bronchial thermoplasty procedure performed as part of the e7088 alair japan pms clinical study.This complaint is being reported based on the event of atelectasis requiring treatment with antibiotics.On (b)(6) 2018 the patient underwent the third bronchial thermoplasty treatment performed on 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 a 'small atelectasis' at the lingual segment of the lungs.Amoxicillin / clavulanate(ampc/cva) was prescribed.As of (b)(6) 2018 the event was resolved with no further patient complications reported.The patient's current condition is stable and the patient is expected to visit the facility on (b)(6) 2018 for followup.In the physician's assessment, it is unknown if the atelectasis was related to the bronchial thermoplasty treatment.Additional information received on 15aug2018.On (b)(6) 2018 the patient recovered from the atelectasis.

• 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
• MDR Report Key: 7532850
• MDR Text Key: 108863215
• Report Number: 3005099803-2018-01649
• 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
• Type of Report: Initial,Followup
• Report Date: 04/25/2018

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
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 08/15/2018
• Supplement Dates FDA Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Weight: 85