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

Catalog Number TC003

Device Problems Decrease in Pressure (1490); Material Perforation (2205)

Patient Problems Internal Organ Perforation (1987); Surgical procedure (2357)

Event Date 08/08/2014

Event Type  Injury  

Event Description

It was reported that a patient underwent an endometrial thermal ablation procedure on (b)(6) 2014.At approximately 6 minutes into the ablation, all pressure in the device was lost.The pressure started to build back up.Once completed, another hysteroscopy was done.It was noted that the ablation did not look complete.The physician looked laparoscopically from above and noted the uterus was perforated.A hysterectomy was performed following the hysteroscopy.The physician reported that an ablation was attempted twice prior this ablation with a different brand of uterine balloon that would not seat.

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.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.This medwatch report is in response to receipt of facility report # (b)(4).

• 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: 4068853
• MDR Text Key: 4815701
• Report Number: 2210968-2014-12555
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: TC003
• Device Lot Number: HEMG05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• 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): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 66