MAUDE MDR 296816

MDR report key
296816
Report number
9615124-2000-00003
Event key
0
Event type
3
Date of event
2000-08-07
Date received
2000-09-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
14001 WESTON PARKWAY STE 103 CARY NC 27513 US
Phone
877-877-8772
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1THERMOFLEX WIT SYSTEMWATER-INDUCED THERMOTHERAPY SYSTEMARGOMED, INC.KNSNA4040551297-12K991847NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12000-09-1901. H

Event Narratives#

D

Patient 1

THE PT WAS TREATED WITH THE THERMOFLEX WIT SYSTEM ON 7/31/2000. ALTHOUGH THE WIT TIEMANN TIP STYLET WAS BENT INTO DIFFERENT CURVES IN AN ATTEMPT TO COMPENSATE FOR A LARGE PROSTATIC URETHRAL HUMP, THE PHYSICIAN HAD DIFFICULTY INSERTING THE CATHETER DUE TO THE PT'S UNUSUAL PROSTATIC ANATOMY. FLEXIBLE CYSTOSCOPY WAS PERFORMED AND A GUIDE WIRE WAS PLACED THROUGH THE CYSTOSCOPE AND THE CYSTOSCOPE WAS REMOVED. THE UROLOGIST THEN CUT THE TIP OFF OF THE WIT CATHETER AND ADVANCED THE WIT CATHETER OVER THE GUIDEWIRE. DUE TO UNCERTAINTY AS TO WHETHER THE CATHETER WAS IN THE BLADDER, THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO PERFORM FLEXIBLE CYSTOSCOPY ALONGSIDE THE WIT CATHETER. THE CATHETER WAS SUCCESSFULLY PLACED BY ADVANCING OVER A WIRE GUIDE. THE PT APPEARED TO EXPERIENCE SEVERE PAIN DURING THE FIRST 10 TO 15 MINUTES OF THE PROCEDURE. THE PAIN SEEMED TO SUBSIDE AFTER THIS PERIOD AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THE PT WAS DISCHARGED WITH A FOLEY CATHETER. IN 2000, THE PT WAS ADMITTED TO AN ER WITH SEVERE HEMATURIA AND SEVERE BLADDER SPASMS. PT WAS TREATED USING ANTI-SPASMODIC MEDICATIONS COMBINED WITH CONTINUOUS BLADDER IRRIGATION. UPON ACHIEVING HEMOSTASIS (WITHOUT TRANSFUSION), SERIAL HEMATOCRITS WERE DRAWN TO MONITOR HEMOCONCENTRATION. THE PT REMAINED AFEBRILE AND WAS DISCHARGED ON 8/12/2000. THE PT IS NOW DOING FINE. THE TREATING UROLOGIST FIRST NOTIFIED ARGOMED OF THIS EVENT ON 8/18/2000.