MAUDE MDR 2615948

MDR report key: 2615948
Report number: 2615948
Event key: 0
Event type: 3
Date received: 2012-06-04
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 500
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
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	THERMACHOICE III	THERMAL BALLOON ABLATION SYSTEM	ETHICON	MKN	*	*	*					R

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2012-06-04	0

Event Narratives#

D

Patient 1

UNABLE TO GET ABLATION MACHINE TO HOLD PRESSURE DURING PROCEDURE. ONE PROBE HAD A LEAK IN IT. CASE ABORTED.======================MANUFACTURER RESPONSE FOR THERMAL BALLOON ABLATION SYSTEM, THERMACHOICE 2 (PER SITE REPORTER).======================MANUFACTURER SENT FOUR KITS TO SEND THE CONTAMINATED CATHETERS BACK FOR INSPECTION AND POSSIBLE CREDIT. CATHETER SALES REP HAD BEEN HERE A MONTH AGO FOR SAME ISSUE, COULD BE RELATED TO TRAINING.

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
PMA	P970021S012	MKN	GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM	Gynecare, Inc.	2005-01-03
PMA	P970021S011	MKN	GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM	Gynecare, Inc.	2004-08-23
PMA	P970021S009	MKN	GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM	Gynecare, Inc.	2003-12-22
PMA	P970021S010	MKN	GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM	Gynecare, Inc.	2003-12-02
PMA	P970021S008	MKN	GYNECARE THERMACHOICE II UTERINE BALLOON THERAPY SYSTEM	Gynecare, Inc.	2003-07-14

MAUDE MDR 2615948

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

Related PMN/PMA Records By Product Code#