FDA.reportPublic FDA data

MAUDE MDR 9908855

MDR report key
9908855
Report number
2134265-2020-04117
Event key
0
Event type
3
Date of event
2020-03-11
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JAY JOHNSON
Address
TWO SCIMED PLACE MAPLE GROVE MN 55311 US
Phone
763-763-7634
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ROTAWIRE AND WIRECLIP TORQUERCATHETER, CORONARY, ATHERECTOMYBOSTON SCIENTIFIC CORPORATIONMCX352035200024003213R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

(B)(6).

D

Patient 1

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.