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

Catalog Number TC043

Device Problem Balloon leak(s) (1052)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2015

Event Type  malfunction  

Event Description

It was reported that the patient underwent thermal ablation on (b)(6) 2015.The catheter primed successfully with no sign of damage.During the procedure, 30 cc of d5w was instilled into the balloon and the pressure was not being maintained.Therapy was terminated at 4 minutes.On checking the catheter after procedure termination, a leak was found in the balloon.The patient was scoped post-termination of treatment and the healthcare provider opined the procedure was adequate and there was no need to continue and no need for another device.The patient will be followed up in a few weeks to determine if repeat treatment is required.There was no adverse patient consequence reported.

Manufacturer Narrative

(b)(4).Conclusion: actual device was returned for evaluation.Visual and functional inspection was performed and the catheter failed the leak test because it had damage balloon due to housing puncture, however no other leaks were found.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: 4557212
• MDR Text Key: 5546571
• Report Number: 2210968-2015-02332
• Device Sequence Number: 1
• Product Code: MNB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 02/05/2015

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 Catalogue Number: TC043
• Device Lot Number: HGMG10
• Other Device ID Number: 10705031050761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/05/2015
• Initial Date FDA Received: 03/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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