STERLING 24700

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 2020-03-24 for STERLING 24700 manufactured by Boston Scientific Corporation.

Event Text Entries

[184813278] It was reported that removal difficulty was encountered with the balloon catheter. The 50% stenosed target lesion was located in an anterior tibial artery. A v-18, 300cm, 8cm poly tip guidewire was used with a 4x100mm sterling balloon catheter. However, when pulling out the wire, the resistance was felt and could not pull out the wire. The physician had to remove the guidewire with sterling balloon catheter as one unit. The procedure was completed with another of the same device. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-03767
MDR Report Key9873482
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-24
Date of Report2020-03-24
Date of Event2020-03-11
Date Mfgr Received2020-03-12
Date Added to Maude2020-03-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 SCIMED, INC
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTERLING
Generic NameCATHETER, PERCUTANEOUS
Product CodeDQY
Date Received2020-03-24
Model Number24700
Catalog Number24700
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 2020-03-24

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