FLEXIMA BILIARY 8.5X7 STENT M00539260

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for FLEXIMA BILIARY 8.5X7 STENT M00539260 manufactured by Boston Scientific Corporation.

Event Text Entries

[185930944] Stent did not break away from the introducer. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093974
MDR Report Key9902913
Date Received2020-03-30
Date of Report2020-03-26
Date of Event2020-03-20
Date Added to Maude2020-03-31
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFLEXIMA BILIARY 8.5X7 STENT
Generic NameSTENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
Product CodeFGE
Date Received2020-03-30
Model NumberM00539260
Lot Number22923324
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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