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 Unspecified Infection (1930)

Event Date 05/28/2018

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.(b)(6).The complainant indicated that the device 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 (b)(6) study.On (b)(6) 2018 the patient was admitted to the hospital as planned for the bt treatment.On (b)(6) 2018 the patient underwent the first bronchial thermoplasty treatment in the right lower lobe of the lungs.No issues were noted with the device.The patient was discharged from the hospital on (b)(6) 2018.According to the complainant, on (b)(6) 2018 the patient experienced lower respiratory tract infection and pleurisy.The patient was hospitalized from (b)(6) 2018 due to this event.The patient had a drainage tube placed from (b)(6) 2018.The patent was administered antibiotic (sulbactam sodium ampicillin sodium)9g/day from (b)(6) 2018.The patient was also administered antibiotic (oral) potassium clavulanate 3 tablets per day from (b)(6) 2018 to (b)(6) 2018.The patient was also administered amoxicillin hydrate 750mg/day from (b)(6) 2018 to (b)(6) 2018.The event has resolved and the patient was discharged without any further issues reported.

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.On (b)(6) 2018 the patient was admitted to the hospital as planned for the bt treatment.On (b)(6) 2018 the patient underwent the first bronchial thermoplasty treatment in the right lower lobe of the lungs.No issues were noted with the device.The patient was discharged from the hospital on (b)(6) 2018.According to the complainant, on (b)(6) 2018 the patient experienced lower respiratory tract infection and pleurisy.The patient was hospitalized from (b)(6) 2018 to (b)(6) 2018 due to this event.The patient had a drainage tube placed from (b)(6) 2018 to (b)(6) 2018.The patent was administered antibiotic (sulbactam sodium ampicillin sodium)9g/day from (b)(6) 2018 to (b)(6) 2018.The patient was also administered antibiotic (oral) potassium clavulanate 3 tablets per day from (b)(6) 2018 to (b)(6) 2018.The patient was also administered amoxicillin hydrate 750mg/day from (b)(6) 2018 to (b)(6) 2018.The event has resolved and the patient was discharged without any further issues reported.Additional information received on 15aug2018.On (b)(6) 2018 the patient recovered from the lower respiratory tract infection and pleurisy.

• 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: 7679635
• MDR Text Key: 113737594
• Report Number: 3005099803-2018-02097
• 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: 06/12/2018

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: 06/12/2018
• Initial Date FDA Received: 07/11/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 41