MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-25 for ALAIR M005ATS25010 ATS 2-5 manufactured by Boston Scientific Corporation.
[143068181]
The complainant was unable to provide the lot number of the suspect device. Therefore, the manufacture and expiration dates are unknown. (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.
Patient Sequence No: 1, Text Type: N, H10
[143068182]
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) 2019. On (b)(6) 2019 the patient underwent the third bronchial thermoplasty procedure performed in the right upper lobe of the lungs. There were no issues noted with the device. According to the complainant, on (b)(6) 2019, the patient had a chest x-ray performed, showing right upper lobe pneumonitis. Additionally, the physician thought the patient had bronchospasms. The patient was admitted to the hospital for this event. However, there were no additional treatment required for the patient's pneumonitis and bronchospasm, just observation. On (b)(6) 2019, the patient was discharged from the hospital in stable condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-02071 |
| MDR Report Key | 8549495 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-25 |
| Date of Report | 2019-04-25 |
| Date of Event | 2019-04-01 |
| Date Mfgr Received | 2019-04-01 |
| Date Added to Maude | 2019-04-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORK LIMITED |
| Manufacturer Street | CORK BUSINESS TECHNOLOGY PARK MODEL FARM ROAD |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALAIR |
| Generic Name | BRONCHIAL THERMOPLASTY SYSTEM |
| Product Code | OOY |
| Date Received | 2019-04-25 |
| Model Number | M005ATS25010 |
| Catalog Number | ATS 2-5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-04-25 |