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,distri report with the FDA on 2020-03-25 for ROTAPRO 3243 manufactured by Boston Scientific Corporation.

Event Text Entries

[185042725] It was reported that the burr and wire became stuck in the lesion. A 1. 75mm rotapro and rotawire floppy 330cm was selected for a percutaneous coronary intervention (pci) procedure in the mid left anterior descending (lad) artery. When the user attempted to withdraw the device, it was noted that the burr was stuck in the lesion. The rotapro and rotawire were removed successfully from the patient body. The procedure was completed by using another of the same device. Patient condition was good, and no complications were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-03792
MDR Report Key9878126
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-25
Date of Report2020-03-25
Date of Event2020-03-05
Date Mfgr Received2020-03-05
Device Manufacturer Date2019-12-04
Date Added to Maude2020-03-25
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 Received2020-03-25
Model Number3243
Catalog Number3243
Lot Number0024873775
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 2020-03-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.