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

Catalog Number TC043

Device Problems Balloon leak(s) (1052); Material Perforation (2205)

Patient Problems Internal Organ Perforation (1987); Pain (1994); Sepsis (2067); Weakness (2145); Surgical procedure (2357); Numbness (2415); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that the patient underwent uterine ablation procedure on an unknown date.During the procedure, the balloon broke at 1.5 minutes during the 8 minute treatment cycle.The patient had a uterine perforation and remained in the hospital for 10 days.The patient underwent another laparoscopy two days later and underwent hysterectomy as the perforation did not heal.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.

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 one pinhole was found on the balloon.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

It was reported by an attorney that the patient underwent a laparoscopy, tubal occlusion with filshie clips, d&c hysteroscopy and thermal ablation on (b)(6) 2015.A thermal ablation catheter was used for the thermal ablation and it was stated that the balloon ¿deflated, releasing hot water¿ and the patient¿s ¿uterus was perforated¿.It was reported that the patient experienced pain with low grade sepsis, and was found to have a large amount of fluid in the abdomen post-procedure.On (b)(6) 2015, the patient had a laparoscopy with insertion of a pelvic drain, and blood was found in the pelvis.She continued to have pain.On (b)(6) 2015 the patient underwent a hysterectomy.The patient continues to have pain, fatigue, bilateral leg numbness, leg weakness, leg spasms, cold and discolored feet and toenails and depression.No additional information is provided at this time.(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 0151
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125, co; l salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4546604
• MDR Text Key: 5512334
• Report Number: 2210968-2015-02104
• Device Sequence Number: 1
• Product Code: MNB
• Combination Product (y/n): N
• 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,company represent
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: TC043
• Device Lot Number: HKMG07
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/25/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2015
• Initial Date FDA Received: 02/25/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/06/2015; 06/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2014
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 33 YR