STERLING 24690

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 STERLING 24690 manufactured by Boston Scientific Corporation.

Event Text Entries

[185940356] (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[185940357] It was reported that balloon rupture occurred. The 99% stenosed, target lesion was located in the mildly tortuous and severely calcified superficial femoral artery. A 6. 0mmx100mmx150cm sterling catheter was advanced for dilation. However, during the second inflation at 8 atmospheres in 10 seconds, the balloon ruptured. The procedure was completed with a different device. The device was completely removed without any issue noted. There no patient complications nor injuries reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-04162
MDR Report Key9904035
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-24
Date Mfgr Received2020-03-25
Device Manufacturer Date2018-10-16
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 StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal Code55311
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTERLING
Generic NameCATHETER, PERCUTANEOUS
Product CodeLIT
Date Received2020-03-31
Model Number24690
Catalog Number24690
Lot Number0022801346
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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