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Adverse Event Report

EDAP TECHNOMED, SA PROSTAPROBE ACCESSORY CATHETER FOR BPH MICROWAVE HYPERTHERMIA DEVICE   back to search results
Catalog Number 219 908
Device Problem Deflation, cause unknown
Event Date 07/19/2000
Patient Outcome  Other;
Event Description

On 7/19/2000, pt presented for a transurethral microwave thermotherapy to treat pt's benign prostatic hyperplasia. The site reported that following the treatment, the catheters foley balloon had a pinhole leak located near distal ligature. Transuretheral ultrasound was performed at insertion and 9 minutes and 23 minutes into the 30 minute treatment. Trans-rectal ultrasound showed balloon inflated and in good position. Physician used the butterfly marker on the catheter and position remained unchanged during treatment. This event is being reported as a similar event could cause a serious injury.

 
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Brand NamePROSTAPROBE
Type of DeviceACCESSORY CATHETER FOR BPH MICROWAVE HYPERTHERMIA DEVICE
Baseline Brand NamePROSTAPROBE
Baseline Generic NameACCESSORY CATHETER FOR BPH MICROWAVE HYPERTHERMIA DEVICE
Baseline Catalogue Number219 908
Other Baseline ID NumberPROSTAPROBE (BLUE)
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
EDAP TECHNOMED, SA
parc d'activites la poud-lamar
4-6 rue du dauphine
vaulx-en-velin
FRANCE 69120
Manufacturer (Section D)
EDAP TECHNOMED, SA
parc d'activites la poud-lamar
4-6 rue du dauphine
vaulx-en-velin
FRANCE 69120
Distributor
EDAP TECHNOMED, INC.
100 pinnacle way, suite 135
norcross, GA 30071
Device Event Key285868
MDR Report Key295341
Event Key277376
Report Number1287394-2000-00071
Device Sequence Number1
Product CodeMEQ
Report Source Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 08/07/2000,09/06/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/06/2000
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date11/01/2001
Device Catalogue Number219 908
Device LOT Number100041
OTHER Device ID NumberPROSTAPROBE (BLUE)
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/20/2000
Device Ageunknown
Event Location Hospital
Date Report TO Manufacturer08/07/2000
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on February 28, 2009

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