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MAUDE MDR 424208

MDR report key
424208
Report number
424208
Event key
0
Event type
3
Date of event
2002-07-05
Date received
2002-10-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AFXABLATION PROBEAFXHPB102008-02UNKF02041603YR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12002-10-2601. R

Event Narratives#

D

Patient 1

AFX FLEX 10 SURGICAL ABLATION PROBE PLACED ON PT BY DOCTOR FOR MINI-MAZE PROCEDURE. PACER SET AT 65 AND TIMER SET AT 90 PER MANUFACTURED RECOMMEDATION. PT WAS NOT YET ON BYPASS BUT AORTIC AND VENOUS CANNULAS WERE IN. DEVICE ACTIVATED-AFTER 35 SECONDS SMOKE WAS NOTED BY DR AND THE ABLATION WAS TERMINATED. THE PROBE HAS AN APPROX 2CM HOLE WITH EXPOSED FINE WIRES. AFX NOTIFIED.

D

Patient 1

ADD'L INFO REC'D FROM USER FACILITY 11/27/02: PLEASE DISREGARD MEDWATCH REPORT #0000490118-2002-0022 FOR AFX MEDICAL DEVICE. THIS IS A DUPLICATE REPORT. ORIGINALLY REPORT SUBMITTED 07/19/02, REPORT #0000490118-2002-0020.