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 01/16/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent an endometrial thermal ablation procedure on (b)(6) 2015.During the procedure, the physician received an error.The physician retrieved the balloon from the patient and noticed a hole in the balloon.Another like device was used to complete the procedure with no adverse patient consequences.

Event Description

It was reported that a patient underwent an endometrial thermal ablation procedure on (b)(6) 2015.During the procedure, the physician received an error.The physician retrieved the balloon from the patient and noticed a hole in the balloon.Another like device was used to complete the procedure with no adverse patient consequences.

Manufacturer Narrative

(b)(4): 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.

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.

Manufacturer Narrative

Additional information was received that indicates this event does not meet malfunction reporting criteria.This event therefore is not reportable.

• 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: 4480063
• MDR Text Key: 5496197
• Report Number: 2210968-2015-00978
• 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: 01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2016
• Device Catalogue Number: TC003
• Device Lot Number: HKMG09
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/06/2015
• Initial Date FDA Received: 02/03/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/03/2015; 03/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/27/2014
• 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