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

Model Number M005ATS25010

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

Patient Problems Dyspnea (1816); Pneumonia (2011)

Event Date 07/01/2018

Event Type  Injury  

Manufacturer Narrative

The patient's exact age was not reported, however, the patient's date of birth was reported to be in (b)(6).The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(6) hospital.Study source - e7088 alair (b)(6) 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 (b)(6) pms clinical study.On (b)(6) 2016 the patient was admitted to the hospital as planned by the physician for the bronchial thermoplasty procedure.On (b)(6) 2016 the patient underwent the third bronchial thermoplasty procedure performed in the lower lobes of the lungs.No issues were noted with the device.According to the complainant, on (b)(6) 2016 the patient experienced dyspnea requiring hospitalization to be extended.The patient was given systemic steroids to treat the dyspnea.On (b)(6) 2016 the dyspnea was in remission.On (b)(6) 2016 the patient developed organized pneumonia requiring hospitalization to be extended.The patient was treated with systemic steroids, along with additional bronchoscopic procedures.The exact dates for these procedures were not reported.On (b)(6) 2016 the patient was discharged from the hospital.On (b)(6) 2016 the patient recovered from the pneumonia.

• Brand Name: ALAIR
• Type of Device: BRONCHIAL THERMOPLASTY SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road,; cork ; EI
• Manufacturer Contact: carole morley ; 100 boston scientific way; marlborough, MA 01752-1242 ; 5086834015
• MDR Report Key: 7836752
• MDR Text Key: 118883623
• Report Number: 3005099803-2018-60185
• Device Sequence Number: 1
• Product Code: OOY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P080032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2018

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: 60073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2018
• Initial Date FDA Received: 08/31/2018
• 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; Other
• Patient Weight: 56