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,foreig report with the FDA on 2020-03-26 for ROTAPRO 3243 manufactured by Boston Scientific Corporation.

Event Text Entries

[187464550] It was reported that a dissection occurred. The complex target lesion was located in the highly calcified and tortuous mid left anterior descending artery (lad). A 1. 75mm rotapro and a 330cm rotawire were selected for use. A 6fr non-bsc guide catheter was used to engage the left main and a non-bsc guidewire was advanced into the distal lad. A microcatheter was used to exchange to the rotawire floppy. The rotapro burr was advanced to the proximal lad with the speed set at 160krpm outside of body. The size of the proximal vessel was approximately 3. 25mm and the distal was approximately 2. 5mm. On advancement, the rotational speed dropped significantly to 60krpm as the burr came into contact with the calcium. During the second run, the burr was advanced through the lesion and was retreated a number of times. Subsequent runs were performed with the burr being advanced through the lesion site and even into the distal vessel. The rota burr was removed under dynaglide without issue. An angiogram was performed and the vessel was patent with no clearly evident dissection. A buddy wire was advanced into the lad along the rotawire, however the distal vessel was not able to be reached. The microcatheter was then used to exchange the rotawire and the buddy wire. Another buddy wire and workhorse wires were placed into the diagonal artery distal to the calcified lesion. A 2. 5x15mm emerge was used to inflate a lesion in the mid lad and also the calicifed lesion in the proximal lad and was removed. A 2. 75x12mm nc emerge was placed at the proximal lad lesion and inflated to prepare the lesion for stenting. A synergy 2. 5x20mm was placed over the buddy wire in the distal lad; however would not pass the calcified lesion and was then removed. A guide extension catheter was passed over the three wires in the vessel and into the mid lad. When the synergy stent was advanced over the wire, there was resistance in the distal lumen segment of the guide extension catheter. The synergy was removed. The resistance occurred due to the wrap of the three guidewires, the two wires in the diagonal vessel were removed, in doing so the buddy wire in the distal lad was also pulled back. The distal lad was not able to be re-wired due to a dissection flap present in the distal lad. The dissection was very faintly noticed on the contrast angiography post rotablation. The vessel had thrombolysis in myocardial infarction (timi) 3 flow. The patient was stable and there was good flow into the distal lad. The procedure was abandoned with the intention to proceed to percutaneous coronary intervention (pci) in a couple of weeks.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-03878
MDR Report Key9883242
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2020-03-20
Date Mfgr Received2020-03-20
Device Manufacturer Date2019-12-19
Date Added to Maude2020-03-26
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 Received2020-03-26
Model Number3243
Catalog Number3243
Lot Number0024957358
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 2020-03-26

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