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,distri report with the FDA on 2020-03-25 for MUSTANG 24674 manufactured by Boston Scientific Corporation.

Event Text Entries

[185035418] It was reported that shaft break occurred. During preparation of a10. 0 x 20, 75cm mustang balloon catheter, while the device was outside the patient, it was noted that the balloon had already been cracked. The procedure was completed with a different device. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-03492
MDR Report Key9881429
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-25
Date of Report2020-03-25
Date of Event2020-03-04
Date Mfgr Received2020-03-04
Device Manufacturer Date2018-09-28
Date Added to Maude2020-03-25
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 Received2020-03-25
Returned To Mfg2020-03-25
Model Number24674
Catalog Number24674
Lot Number0022720676
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressTWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-25

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