FDA.reportPublic FDA data

MAUDE MDR 9908716

MDR report key
9908716
Report number
2134265-2020-04197
Event key
0
Event type
3
Date of event
2020-03-17
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
1MUSTANGCATHETER, BILIARY, DIAGNOSTICBOSTON SCIENTIFIC CORPORATIONFGE24674246740024489070R N

Patients#

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

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE CHRONIC 50% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS BUT SEVERELY CALCIFIED SUBCLAVIAN ARTERY. A 6.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, ON INITIAL INFLATION AT 22 ATMOSPHERES FOR 60 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 6.0 X 60, 75CM MUSTANG BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS GOOD.