FDA.reportPublic FDA data

MAUDE MDR 1463549

MDR report key
1463549
Report number
3003870001-2009-00009
Event key
0
Event type
3
Date of event
2009-08-27
Date received
2009-09-02
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
PHYLLIS PIET-HUGHES
Address
ONE ST. JUDE MEDICAL DRIVE ST. PAUL MN 55117 US
Phone
651-651-6517
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ULTRACINCH LP, 10 CELL, UC-LP-10ULTRACINCH LP, 10 CELLST. JUDE MEDICALNTB12545NANAR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-09-0201. O

Event Narratives#

D

Patient 1

IT WAS REPORTED DURING A MVR AND ABLATION PROCEDURE, AN EPICOR ULTRACINCH DEVICE WAS UTILIZED AND MITRAL VALVE WAS REPAIRED. AT THE END OF THE PROCEDURE, THE PT WAS OFF-PUMP BUT STILL CANNULATED, AND A LARGE HEMATOMA WAS DISCOVERED ON THE PA. THE PT WAS PLACED BACK ON PUMP, AND THE HEMATOMA WAS REPAIRED. THE PT IS REPORTEDLY RECOVERING. THE SURGEON WAS NOT CERTAIN OF WHAT CAUSED THE DAMAGE TO THE PA. A SWAN GANZ CATHETER AND TEE ECHO PROBE WERE USED.

N

Patient 1

THE DEVICE WAS NOT RETURNED FOR EVAL. HOWEVER, REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO PROVIDED, THE CAUSE FOR THE REPORTED HEMATOMA REMAINS UNK. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: 9/2/2009. DATE THE INITIAL REPORTER PROVIDED THE INFO TO THE MANUFACTURER: 8/27/2009.