FDA.reportPublic FDA data

MAUDE MDR 1397273

MDR report key
1397273
Report number
3007456607-2009-00003
Event key
0
Event type
3
Date of event
2009-03-07
Date received
2009-04-06
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#

Address
1111 SHORT RD 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, LLCDQXOP3015OP30152009-09-08R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-04-0601. O

Event Narratives#

D

Patient 1

OSTIAL PRO CYLINDER BECAME DETACHED AFTER DEPLOYMENT FROM A MEDTRONIC 6FR RDC GUIDE FOLLOWED BY A COOK 6 X 16 MM FORMULA STENT. THE OSTIAL PRO CYLINDER WAS SNARED AND THEN REMOVED VIA THE SHEATH. CASE WAS SUCCESSFULLY COMPLETED, PT IS FINE AND NO OTHER COMPLICATIONS WERE REPORTED. THE DEVICE HAS BEEN RETURNED FOR FURTHER TESTING AND EVALUATION.

N

Patient 1

A DEVICE HAS NOT BEEN PHYSICALLY EVALUATED AT THIS TIME. THE INVESTIGATION REVEALED AN INCORRECT CROSSING PROFILE WAS USED, WHICH HAS BEEN KNOWN TO CAUSE THIS TYPE OF FAILURE. THE ACTUAL DEVICE THAT FAILED HAS NOT BEEN RETURNED TO THE MANUFACTURER SO FURTHER INVESTIGATION IS NOT POSSIBLE AT THIS TIME. LABELING IS IN THE PROCESS OF BEING UPDATED TO ADD A PRECAUTIONARY STATEMENT WHICH STATES THE POTENTIAL ISSUES THAT MAY RESULT FROM THIS TYPE OF MISUSE. BOX C5 IS NOT SUPPOSED TO BE CHECKED, HOWEVER THE FORM WILL NOT ALLOW IT TO BE UNCHECKED.