ROTAWIRE AND WIRECLIP TORQUER

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 2020-03-11 for ROTAWIRE AND WIRECLIP TORQUER manufactured by Boston Scientific Corporation.

Event Text Entries

[183098810] It was reported that the device became wrapped in the wire. A 1. 50mm rotablator rotalink plus and rotawire were selected for use for an atherectomy procedure in the stenosed left anterior descending artery (lad). During the procedure, the device stopped and a stall message displayed. The rotawire had wrapped around the rotablator device not allowing the burr to rotate. The physician removed the wire and the burr together and completed the procedure successfully with a new device. No patient complications were reported and patient was reported as stable post procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-02908
MDR Report Key9819757
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-11
Date of Report2020-03-11
Date of Event2020-03-02
Date Mfgr Received2020-03-02
Date Added to Maude2020-03-11
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 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 Received2020-03-11
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 2020-03-11

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