MAUDE MDR 2999921

MDR report key: 2999921
Report number: 2133936-2013-00001
Event key: 0
Event type: 3
Date of event: 2013-01-21
Date received: 2013-03-12
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#

Contact: MRS. HOPE PRZYBILLA
Address: 14405 21ST AVENUE N SUITE 110 MINNEAPOLIS MN 55447 US
Phone: 763-763-7634
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	TARGIS SYSTEM	MICROWAVE DELIVERY SYSTEM	UROLOGIX, INC	MEQ	410097-001	410097-001	121024MCA1				Y	R

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2013-03-12	0

Event Narratives#

D

Patient 1

APPROXIMATELY A THIRD OF THE WAY THROUGH TREATMENT, IT WAS DETECTED BY ULTRASOUND THAT THE ANCHOR BALLOON HAD BEEN LEAKING AND NOT HOLDING THE 10CC'S OF WATER. THE DR. ELECTED TO PULL THE ENTIRE KIT, RTU AND CATHETER AND START COMPLETELY OVER WITH ALL NEW PRODUCT.

N

Patient 1

THE DEVICE HISTORY RECORD FOR THE CATHETER WAS REVIEWED; ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH STANDARD PROCEDURES, AND THE DEVICE MET SPECIFICATIONS AT THE TIME OF RELEASE. THE CATHETER WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION OF THE CATHETER CONFIRMED THAT THE LOCATION BALLOON WAS LEAKING NOT FROM THE GLUE SEAMS BUT A PRESSURE PUNCTURE HOLE. FOLLOW-UP WITH THE APPLICATION SPECIALIST PRESENT FOR THE TREATMENT INDICATED THAT THERE WAS DIFFICULTY DURING INSERTION. HOWEVER, THE BALLOON WAS TESTED PRE-TREATMENT AND WAS PASSING. BASED ON THIS INFORMATION, IT IS LIKELY THAT THE LOCATION BALLOON WAS DAMAGED DURING THE INSERTION PROCESS.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
07350081910013	CoreTherm	Prostalund AB	MEQ	2016-03-07
07350081910020	CoreTherm	Prostalund AB	MEQ	2016-03-07
07350081910037	CoreTherm	Prostalund AB	MEQ	2016-03-07
07350081910044	CoreTherm	Prostalund AB	MEQ	2016-03-07
07350081910051	CoreTherm	Prostalund AB	MEQ	2016-03-07
07350081910068	CoreTherm	Prostalund AB	MEQ	2016-03-07
07350081910075	CoreTherm	Prostalund AB	MEQ	2016-03-07
07350081910082	CoreTherm	Prostalund AB	MEQ	2016-03-07
M876PT10340	Targis	Urologix LLC	MEQ	2014-09-26
M876PT10360	Targis	Urologix LLC	MEQ	2014-09-26
M876PT10380	Targis	Urologix LLC	MEQ	2014-09-26
M876RB3131A1	Targis	Urologix LLC	MEQ	2014-09-26
M876RB3131A2	Targis	Urologix LLC	MEQ	2014-09-26

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
PMA	P010055S011	MEQ	ProstaLund CoreTherm System Microwave Thermotherapy for BPH	Prostalund AB	2021-06-30
PMA	P030006S028	MEQ	Prolieve Thermodilation System	Medifocus, Inc.	2018-11-21
PMA	P970008S065	MEQ	UROLOGIX TARGIS SYSTEM	Urologix, LLC	2015-10-29
PMA	P970008S064	MEQ	UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH	Urologix, LLC	2015-08-28
PMA	P030006S027	MEQ	PROLIEVE THERMODILATATION SYSTEM	Medifocus, Inc.	2014-12-16

MAUDE MDR 2999921

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

N

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#