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 12/04/2014

Event Type  malfunction  

Manufacturer Narrative

Conclusion: the actual device involved in this event was returned for evaluation.Upon evaluation, the balloon was detached from the catheter.Conclusion: representative samples were returned for evaluation.The evaluation found pinholes in the balloons.

Manufacturer Narrative

Conclusion: representative samples were evaluated.No pinholes or other damages were found on the balloon.Pressure in catheter worked as intended on testing.The actual device passed functional electrical testing.No device failure detected and the product is within specification.

Event Description

It was reported that a patient underwent a thermal ablation procedure on (b)(6) 2014.The surgeon primed the catheter without difficulty, titration was completed successfully, and the start button was pressed.During the preheat phase an overheating error occurred.The fluid was removed from the catheter and only 20cc of the 25cc of inserted fluid was retrieved.When the catheter was removed from the patient¿s uterus it was noted that the balloon was almost completely detached from the probe and appeared to have some char on it.The surgeon aborted the procedure.A hysteroscopy was done prior to beginning the procedure and after the device was removed and there were no adverse patient consequences.

Manufacturer Narrative

(b)(4).Conclusion: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.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: 4418804
• MDR Text Key: 12930618
• Report Number: 2210968-2015-00330
• 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,Followup
• Report Date: 12/18/2014

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: 08/31/2016
• Device Catalogue Number: TC003
• Device Lot Number: HJMG04
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/22/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2015
• Initial Date FDA Received: 01/14/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/13/2015; 02/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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