ALAIR M005ATS25010 ATS 2-5

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number3005099803-2018-61923
MDR Report Key8168973
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-12-17
Date of Report2018-12-17
Date of Event2018-09-12
Date Mfgr Received2018-11-21
Date Added to Maude2018-12-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactCAROLE MORLEY
Manufacturer Street100 BOSTON SCIENTIFIC WAY ,
Manufacturer CityMARLBOROUGH MA 017521242
Manufacturer CountryUS
Manufacturer Postal017521242
Manufacturer Phone5086834015
Manufacturer G1BOSTON SCIENTIFIC CORK LIMITED
Manufacturer StreetCORK BUSINESS TECHNOLOGY PARK MODEL FARM ROAD,
Manufacturer CityCORK
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameALAIR
Generic NameBRONCHIAL THERMOPLASTY SYSTEM
Product CodeOOY
Date Received2018-12-17
Model NumberM005ATS25010
Catalog NumberATS 2-5
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address100 BOSTON SCIENTIFIC WAY , MARLBOROUGH MA 017521242 US 017521242


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2018-12-17

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