FDA.reportPublic FDA data

MAUDE MDR 2732175

MDR report key
2732175
Report number
1028232-2012-02165
Event key
0
Event type
3
Date of event
2012-07-10
Date received
2012-08-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
6024 JEAN ROAD LAKE OSWEGO OR 97035 US
Phone
877-877-8772
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PASSEO-35 6/100/130BALLOON CATHETERBIOTRONIK AGDQY35732335732312114587* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-08-3001. H

Event Narratives#

D

Patient 1

OUS MDR - A MODERATELY CALCIFIED PERIPHERAL ARTERIAL OCCLUSION WITH A STENOSIS DEGREE OF 80%, A VASCULAR DIAMETER OF 6 MM, AND A LENGTH OF 100 MM WAS TREATED. DURING DILATATION OF THE PASSEO-35, A BALLOON RUPTURE OCCURRED AT A PRESSURE OF 14 BAR, WHICH LED TO A RUPTURE OF THE VESSEL. THE VESSEL RUPTURE WAS SUCCESSFULLY TREATED WITH A COVERED STENT. THE PT WAS DISCHARGED FROM THE HOSPITAL WITHOUT FURTHER CONSEQUENCES.

N

Patient 1

OUS MDR.