MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-12-17 for ALAIR M005ATS25010 ATS 2-5 manufactured by Boston Scientific Corporation.
[130486233]
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. Study source - (b)(6) clinical study. (b)(4). 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.
Patient Sequence No: 1, Text Type: N, H10
[130486234]
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) clinical study. On (b)(6) 2018 the patient underwent the third bronchial thermoplasty treatment 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 wheezing requiring hospitalization to be extended. The patient was treated with systemic steroids. On (b)(6) 2018 the patient recovered from the wheezing and was discharged from the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-61923 |
| MDR Report Key | 8168973 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-17 |
| Date of Report | 2018-12-17 |
| Date of Event | 2018-09-12 |
| Date Mfgr Received | 2018-11-21 |
| Date Added to Maude | 2018-12-17 |
| 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 | 100 BOSTON SCIENTIFIC WAY , |
| Manufacturer City | MARLBOROUGH MA 017521242 |
| Manufacturer Country | US |
| Manufacturer Postal | 017521242 |
| 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 | 2018-12-17 |
| 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 | 100 BOSTON SCIENTIFIC WAY , MARLBOROUGH MA 017521242 US 017521242 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-12-17 |