MAUDE Adverse Event Report: ETHICON INC. GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY; DEVICE, THERMAL ABLATION, ENDOMETRIAL

Catalog Number TC033

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Death (1802)

Event Type  Death  

Event Description

It was reported that a female underwent an endometrial thermal ablation procedure on (b)(6) 2011.It was reported that the surgeon counseled the patient on the fact that the endometrial thermal ablation was not a sterilization method and that appropriate birth control measures should be taken.The procedure was completed successfully.In 2013, the patient became pregnant and chose to keep the pregnancy though the surgeon advised termination.At 29 weeks gestation, a cesarean section was performed by a different physician.The baby did not survive.There was no further information provided on the cause of death of the baby or the reason the female underwent a cesarean section at 29 weeks.Additional information has been requested.

Manufacturer Narrative

(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

• Brand Name: GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY
• Type of Device: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON INC. - JUAREZ; avenida de las torres 7125, co; l salvacar; ciudad juarez 3260 4; MX 32604
• Manufacturer Contact: ellen reuss ; route 22 west po box 151; somerville, NJ 08876 ; 9082183095
• MDR Report Key: 3651566
• MDR Text Key: 4195929
• Report Number: 2210968-2014-01799
• Device Sequence Number: 1
• Product Code: MNB
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P970021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TC033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention