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 2019-04-01 for ALAIR M005ATS25010 ATS 2-5 manufactured by Boston Scientific Corporation.
[140511620]
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. Study source - (b)(6). Problem code 1726 captures the reportable event of exacerbation of asthma requiring hospitalization. According to the complainant, the suspect device is not available for return. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[140511621]
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) 2017 as part of the (b)(6) clinical study. On (b)(6) 2017 the patient was admitted to the hospital as planned by the physician for the bronchial thermoplasty treatment. On (b)(6) 2017 the patient underwent the first bronchial thermoplasty procedure performed in the right lower lobe of the lungs. No issues noted with the device. On (b)(6) 2017 the patient was discharged from the hospital following the bronchial thermoplasty treatment. According to the complainant, on (b)(6) 2017 the patient experienced asthma exacerbation and was treated with systemic steroids. The patient was hospitalized due to this event. On (b)(6) 2017 the patient recovered from the asthma exacerbation and was discharged from the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-01571 |
| MDR Report Key | 8470352 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-01 |
| Date of Report | 2019-04-01 |
| Date of Event | 2017-09-20 |
| Date Mfgr Received | 2019-03-05 |
| Date Added to Maude | 2019-04-01 |
| 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 | 2019-04-01 |
| 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 | 2019-04-01 |