FDA.reportPublic FDA data

MAUDE MDR 1471725

MDR report key
1471725
Report number
3003870001-2009-00006
Event key
0
Event type
3
Date of event
2009-06-08
Date received
2009-06-15
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 DR. 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, DEPLOYABLE TISSUE ABLATION, 11 CELLULTRACINCH, UC-LP-11ST. JUDE MEDICALNTBNA12546NAN Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-06-150

Event Narratives#

N

Patient 1

WE ARE IN THE PROCESS OF INVESTIGATING THIS EVENT. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

D

Patient 1

IT WAS REPORTED THE PHYSICIAN ATTEMPTED TO DO AN ABLATION WITH AN ULTRACINCH LP DEVICE. THE DEVICE WAS PREPPED ACCORDING TO THE IFU AND PASSED AROUND THE LEFT ATRIUM WITHOUT DIFFICULTY. APPROXIMATELY 3 MINUTES INTO THE ABLATION, AN ERROR MESSAGE ON THE ACS INDICATING DAMAGED DISPOSABLE - CELL 10 OUT OF RANGE WAS DISPLAYED. THE SJM REP ATTEMPTED TO DISCONNECT AND RECONNECT THE CABLE WHICH DID NOT RESOLVE THE PROBLEM. THE ABLATION WAS CONTINUED WITHOUT CELL 10. THE SURGEON THEN ATTEMPTED TO ABLATE WITH THE WAND AND HEARD POPPING. ABOUT ONE MINUTE INTO THE ABLATION THE SURGEON NOTED STEAM AND HEATED SALINE FLOWING FROM THE WAND, AT WHICH POINT HE ELECTED TO PAUSE THE ABLATION, AFTER ABOUT 2 MINUTES AND AFTER CONFIRMING THAT THE CELLS WERE FREE OF AIR, HE PROCEEDED TO PERFORM AN ADDITIONAL 30 SECOND ABLATION. THE PHYSICIAN TOLD THE SJM REP HE FELT THE WAND WAS DANGEROUS AND THAT ONE NEEDS TO BE CAREFUL WHEN USING IT.