FDA.reportPublic FDA data

MAUDE MDR 1367407

MDR report key
1367407
Report number
3003870001-2009-00002
Event key
0
Event type
3
Date of event
2009-04-07
Date received
2009-04-21
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
14901 DEVEAU PLACE MINNETONKA MN 55345 US
Phone
952-952-9529
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ULTRACINCH DEPLOYABLE TISSUE ABLATION UC-11ULTRACINCH, UC-11ST. JUDE MEDICALNTBNA11479NAR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-04-2101. O

Event Narratives#

D

Patient 1

THE PHYSICIAN PLACED AN EPICOR ULTRACINCH DEVICE AROUND THE LEFT ATRIUM. HALFWAY THROUGH THE ABLATION, THE PATIENT'S PRESSURE DROPPED AND ARTERIAL BLOOD WAS OBSERVED FLOWING FROM AN AREA NEAR THE LEFT ATRIAL APPENDAGE. ABLATION WAS CONTINUED AND THE SURGEON REPAIRED THE AREA OF BLOOD LEAK WITH TWO SUTURES.

N

Patient 1

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE CAUSE FOR THE REPORTED DROP IN BLOOD PRESSURE AND BLEEDING REMAINS UNKNOWN.