WALLSTENT ENDOPROSTHESIS 26280

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-30 for WALLSTENT ENDOPROSTHESIS 26280 manufactured by Boston Scientific Corporation.

Event Text Entries

[178645248] It was reported that tip detachment occurred. During unpacking of a 20x55/10fr uni plus 75cm wallstent, it was noted that the stent deployment tip was missing while the distal radiopaque marker band was still intact. Upon further inspection, the missing tip was not in the packing either. The procedure was completed with another wall stent. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-00649
MDR Report Key9646749
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-30
Date of Report2020-03-18
Date of Event2020-01-10
Date Mfgr Received2020-03-03
Device Manufacturer Date2019-10-17
Date Added to Maude2020-01-30
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 NameWALLSTENT ENDOPROSTHESIS
Generic NameCATHETER, BILIARY, DIAGNOSTIC
Product CodeJCT
Date Received2020-01-30
Returned To Mfg2020-01-23
Model Number26280
Catalog Number26280
Lot Number0024610411
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressTWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-30

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