ALAIR M005ATS25010 60073

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 2018-09-18 for ALAIR M005ATS25010 60073 manufactured by Boston Scientific Corporation.

Event Text Entries

[120557954] The patient's exact date of birth was not reported, however, it was reported that the patient was born in (b)(6). 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). 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


[120557955] 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 for the bronchial thermoplasty procedure. On (b)(6) 2017 the patient underwent the third bronchial thermoplasty procedure performed in the right and left upper lobes of the lungs. No issues were noted with the device. According to the complainant, following the procedure, the patient developed an asthma exacerbation requiring hospitalization to be extended. The patient was given systemic steroids to treat the asthma exacerbation. On (b)(6) 2017 the patient was discharged from the hospital. On (b)(6) 2017 the asthma exacerbation was in remission.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2018-60482
MDR Report Key7885471
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-09-18
Date of Report2018-09-18
Date of Event2017-04-19
Date Mfgr Received2018-08-24
Date Added to Maude2018-09-18
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 Received2018-09-18
Model NumberM005ATS25010
Catalog Number60073
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 2018-09-18

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