FDA.reportPublic FDA data

MAUDE MDR 9908810

MDR report key
9908810
Report number
2134265-2020-04067
Event key
0
Event type
3
Date of event
2020-03-06
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
1ROTALINK PLUSCATHETER, CORONARY, ATHERECTOMYBOSTON SCIENTIFIC CORPORATIONMCX324132410024677418R N

Patients#

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

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE SHAFT WAS LEAKING FLUID. A 1.25MM ROTALINK PLUS WAS SELECTED FOR USE. UPON PREPARATION, THE DEVICE WAS PROPERLY MOUNTED ON A ROTAWIRE FLOPPY WITHOUT ANY ISSUE. HOWEVER, A VERTICAL LEAK OF USUAL SOLUTION WAS COMING FROM THE INFUSED BAG. THERE WAS A SMALL HOLE IN THE MIDDLE OF THE SHAFT NOTICED DURING THE SPEED TEST. THE PROCEDURE WAS STOPPED, AND DEVICE WAS REPLACED WITH ANOTHER OF THE SAME. NO PATIENT COMPLICATIONS WERE REPORTED.