ROTAWIRE AND WIRECLIP TORQUER 3520

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 2020-03-31 for ROTAWIRE AND WIRECLIP TORQUER 3520 manufactured by Boston Scientific Corporation.

Event Text Entries

[185941354] (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[185941355] It was reported that the rotawire tip was separated. The 90% stenosed target lesion was located in the severely calcified artery. A 330cm rotawire and a rotaburr were selected for use. During procedure, it was noted that the spring coil of the radiopaque (ro) marker at the wire tip was loosened and was found to be separated under cine. The devices were removed for each system and 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 Number2134265-2020-04117
MDR Report Key9908855
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-11
Date Mfgr Received2020-03-11
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 DE COSTA RICA S.R.L.
Manufacturer Street302 PARKWAY, GLOBAL PARK
Manufacturer CityLA AURORA - HEREDIA
Manufacturer CountryCS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameROTAWIRE AND WIRECLIP TORQUER
Generic NameCATHETER, CORONARY, ATHERECTOMY
Product CodeMCX
Date Received2020-03-31
Model Number3520
Catalog Number3520
Lot Number0024003213
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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