FDA.reportPublic FDA data

MAUDE MDR 9783369

MDR report key
9783369
Report number
2134265-2020-02368
Event key
0
Event type
3
Date of event
2020-01-31
Date received
2020-03-03
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
1REBELSTENT, CORONARYBOSTON SCIENTIFIC CORPORATIONMAF10291102910020501828N R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-030

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 32 X 3.50 REBEL STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, THE DISTAL PROTECTIVE STYLET WAS DIFFICULT TO REMOVE AND THE STENT DELIVERY SYSTEM FRACTURED AT ABOUT THE MONORAIL WIRE OUTLET AREA. THE PROCEDURE WAS COMPETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.