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

Catalog Number TC003

Device Problem Balloon leak(s) (1052)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2014

Event Type  malfunction  

Event Description

It was reported that the patient underwent endometrial ablation on (b)(6) 2014.During the first minutes of the treatment phase, 15 cc of fluid was inserted and an overheat error was noted.The fluid was removed from the catheter.When catheter was removed from uterus, 12 cc of fluid was retrieved and a hole was discovered in the balloon.The physician opined the fluid felt lukewarm, not hot.A hysteroscopy was performed and no burn was noted or adverse patient consequence.The procedure was completed with a like device.No additional information was provided.

Manufacturer Narrative

(b)(4).Conclusion: the product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Manufacturer Narrative

Conclusion: the actual device involved in this event was returned for evaluation.The device was visually and functionally evaluated.Upon evaluation, the device did not maintain pressure because the balloon had burst.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• 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: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4275874
• MDR Text Key: 5011028
• Report Number: 2210968-2014-16165
• Device Sequence Number: 1
• Product Code: MNB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: TC003
• Device Lot Number: HEMG08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2014
• Initial Date FDA Received: 11/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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