FDA.reportPublic FDA data

MAUDE MDR 678624

MDR report key
678624
Report number
9616058-2005-00002
Event key
0
Event type
3
Date of event
2006-01-26
Date received
2006-02-21
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
DOV MAOR, VICE PRESIDENT
Address
5 NACHUM HETH STREET P.O. BOX 2039 TIRAT CARMEL 31290 IS
Phone
972-972-9724
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EXABLATE 2000FOCUSED ULTRASOUNDINSIGHTEC, LTD.MIKEXABLATE 2000**NYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-02-2101. H; 2. L; 3. R

Event Narratives#

D

Patient 1

BASED ON THE INFORMATION PROVIDED TO INSIGHTEC BY THE FACILITY IN 2006, IT APPEARS THAT A PT WHO HAD UNDERGONE A 2.5 HOUR EXABLATE 200 TREATMENT FOR UTERINE FIBROIDS IN 2005 WAS DIAGNOSED WITH A NON-OCCLUSIVE THROMBUS IN HER RIGHT LEG THE DAY AFTER RECEIVING THE MR GUIDED FOCUSED ULTRASOUND ("MRGFUS") TREATMENT. THIS EVENT WAS DETERMINED BY THE TREATING DOCTOR TO BE "POSSIBLY RELATED" TO THE DEVICE, ALTHOUGH NO EXPLANATION AS TO HOW THE EVENT COULD BE RELATED TO THE TREATMENT IS PROVIDED. ACCORDING TO THE CLINIC, THE PT WAS HOSPITALIZED FOR SEVERAL DAYS, RECEIVED TREATMENT (I.E., ADMINISTRATION OF ANTICOAGULANT) AND LATER UNDERWENT A PERCUTANEOUS THROMBECTOMY AT A DIFFERENT FACILITY.