FDA.reportPublic FDA data

MAUDE MDR 2651325

MDR report key
2651325
Report number
1721504-2009-00211
Event key
0
Event type
3
Date of event
2009-02-16
Date received
2009-03-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
KEVIN PLEMMONS
Address
1111 SHORT ROAD KALAMAZOO MI 49008 US
Phone
866-866-8668
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OSTIAL PRO STENT POSITIONING SYSTEMDQX WIRE, GUIDE, CATHETEROSTIAL SOLUTIONS, LLCDQXOP3015OP30152009-09-05R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-03-1841. O

Event Narratives#

D

Patient 1

DURING BI-LATERAL RENAL STENT PLACEMENT. WHILE WORKING ON THE RIGHT RENAL ARTERY THERE WAS A PERFECT PLACEMENT OF THE FIRST STENT USING THE OSTIAL PRO. WHEN THE DOCTOR WAS REMOVING THE OSTIAL PRO AFTER SUCCESSFUL STENT PLACEMENT IN THE LEFT RENAL OSTIUM HE WAS RETRACTING THE OSTIAL PRO INTO THE GUIDING CATHETER WHEN HE FELT A "LITTLE MORE RESISTANCE" THEN NORMAL RETRACTING THE OSTIAL PRO INTO THE TIP OF THE GUIDING CATHETER. WHEN RETRACTING THE OSTIAL PRO INTO THE GUIDING CATHETER THE DOCTOR THEN LOOKED UP TO THE MONITOR AND SAW THE CYLINDER OF THE OSTIAL PRO DEVICE FLOATING IN THE AORTA. THE CYLINDER OF THE DEVICE MIGRATED DISTALLY TO THE ILIAC ARTERY AND WAS STABILIZED WITH A COVERED STENT TO TRAP IT IN PLACE. A COVERED STENT WAS USED BECAUSE THE ILIAC WAS PERFORATED WHILE THE DOCTOR WAS ATTEMPTING TO SNARE THE DISLODGED CYLINDER OF THE OSTIAL PRO. THE DOCTOR STATED HE DID NOT DO ANYTHING DIFFERENTLY THAN MANY OTHER CASES USING THE SAME DEVICE. THE PRODUCT AND ALL OTHER MATERIAL USED DURING THE CASE WERE DISPOSED OF AND NOT AVAILABLE FOR FURTHER TESTING. PATIENT IS FINE, DISCHARGED AND NO COMPLICATIONS HAVE BEEN REPORTED.

N

Patient 1

NO DEVICE RETURNED FOR EVALUATION. MULTIPLE ATTEMPTS/REQUESTS FOR RETURN WERE MADE WITHOUT SUCCESS. INITIAL WELD DESIGN DID NOT CONSIDER ALL FORESEEABLE MISUSE. NEW DESIGN IS BEING IMPLEMENTED TO CORRECT.