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

Catalog Number TC033

Device Problem Balloon leak(s) (1052)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2015

Event Type  malfunction  

Event Description

It was reported that the patient underwent thermal ablation on (b)(6) 2015.The catheter was primed and inserted into the uterus and preheating started.It was noted that there was no sound of the impeller turning and the preheating cycle was stopped.The generator restarted and the preheating was started again.At approximately 30 degrees, it was noted that dextrose was leaking, running along the umbilical cable.The balloon was intact.The catheter was removed and the procedure was completed successfully with a like device.There was no adverse patient consequence reported.

Manufacturer Narrative

(b)(4): 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.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

During the procedure, there was no twist in the pressure line noted.The device was silent.The surgeon requested that the generator be switched off and the catheter be re-primed.It was reported that it seemed to be leaking from the handle.When the balloon was inflated outside the patient, the balloon was intact.Once the catheter was removed from the uterus, only a drop of fluid was noted on the umbilical cord.The difference in the amount of fluid inserted and removed cannot be confirmed as it was too a small difference.When the catheter balloon was reinflated with fluid once removed from the uterus to check for a pinhole leak, the balloon was found intact.Conclusion: the actual device involved in this event was returned for evaluation.The device was visually and functionally evaluated.Upon evaluation, the catheter failed the leak test because it had a damaged balloon due to housing protrude, however no other leaks were found.

Manufacturer Narrative

Additional information was received that indicates this event does not meet malfunction reporting criteria.This event is therefore 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: mary szaro ; route 22 west po box 151; somerville, NJ 08876 ; 9082183464
• MDR Report Key: 4799761
• MDR Text Key: 5916416
• Report Number: 2210968-2015-06461
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2016
• Device Catalogue Number: TC033
• Device Lot Number: HBMG09
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/27/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/26/2014
• 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