FDA.reportPublic FDA data

MAUDE MDR 9887082

MDR report key
9887082
Report number
2134265-2020-03677
Event key
0
Event type
3
Date of event
2020-03-12
Date received
2020-03-26
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
1WOLVERINE CORONARY CUTTING BALLOON MONORAILCATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORINGBOSTON SCIENTIFIC CORPORATIONNWX385138510025020284R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-260

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT A BLADE LIFT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 10MM X 3.00MM WOLVERINE CUTTING BALLOON WAS ADVANCED TO THE TARGET LESION, BUT IT WAS NOTICED THAT AFTER THE CUTTING PROCESS, ONE CUTTER WAS NOT FIXED AS NORMAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT AND THE PATIENT WAS REPORTED TO BE FINE AND STABLE FOLLOWING THE PROCEDURE.