ROTAPRO 3243

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 2020-03-24 for ROTAPRO 3243 manufactured by Boston Scientific Corporation.

Event Text Entries

[184742778] It was reported that device entrapment and vessel dissection occurred. A 1. 25mm rotapro and rotawire and wireclip torquer were selected for use in the tortuous mid right coronary artery. The rotawire was advanced without difficulty through and beyond the lesion. During the procedure, the 1. 25 burr stopped in the middle of the lesion. No stall had displayed and the rpms did not drop below 150,000rpm. The burr became lodged in the lesion and stuck on the wire. Significant resistance was experienced when attempting to remove or advance the burr. Neither the wire nor burr would move forward or backward. The burr and the wire seemed to be fused and entrapped together. In order to remove the device, the burr and wire had to be forcefully removed together and a dissection of the right coronary artery occurred. A covered stent had to be placed. The dissection was fixed and the patient was stable post procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-03739
MDR Report Key9871715
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-24
Date of Report2020-03-24
Date of Event2020-02-28
Date Mfgr Received2020-03-02
Device Manufacturer Date2019-07-15
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
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 StreetMODEL FARM ROAD
Manufacturer CityCORK
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameROTAPRO
Generic NameCATHETER, CORONARY, ATHERECTOMY
Product CodeMCX
Date Received2020-03-24
Model Number3243
Catalog Number3243
Lot Number0024108640
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
101. Required No Informationntervention 2020-03-24

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