MUSTANG 24674

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 2020-03-31 for MUSTANG 24674 manufactured by Boston Scientific Corporation.

Event Text Entries

[185941655] It was reported that balloon rupture occurred. The chronic 50% stenosed target lesion was located in the non-tortuous but severely calcified subclavian artery. A 6. 0 x 60, 75cm mustang balloon catheter was advanced for dilatation; however, on initial inflation at 22 atmospheres for 60 seconds, the balloon ruptured. The procedure was completed with another 6. 0 x 60, 75cm mustang balloon catheter. There were no patient complications nor injuries reported and the patient was good.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-04197
MDR Report Key9908716
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-17
Date Mfgr Received2020-03-17
Device Manufacturer Date2019-09-25
Date Added to Maude2020-03-31
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 ContactJAY JOHNSON
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone7634942574
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer StreetBALLYBRIT BUSINESS PARK
Manufacturer CityGALWAY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMUSTANG
Generic NameCATHETER, BILIARY, DIAGNOSTIC
Product CodeFGE
Date Received2020-03-31
Model Number24674
Catalog Number24674
Lot Number0024489070
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressTWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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