MAUDE Adverse Event Report: ETHICON - GYNECARE THERMACHOICE; UTERINE BALLOON

Catalog Number TC003

Device Problems Decrease in Pressure (1490); Malfunction (2409)

Patient Problem Uterine Perforation (2121)

Event Date 08/08/2014

Event Type  Injury  

Event Description

Attempted ablation twice with a different brand of uterine balloon that would not seat.Thermachoice balloon started; at approximately 6 minutes into the ablation, lost all pressure in the device.Pressure started to build back up.Once completed, another hysteroscopy was done.Noted that ablation did not look complete.Looked laparoscopically from above and noted that the uterus was perforated.

• Brand Name: THERMACHOICE
• Type of Device: UTERINE BALLOON
• Manufacturer (Section D): ETHICON - GYNECARE; po box 151, route 22 west; summerville NJ 08876 015
• MDR Report Key: 4088411
• MDR Text Key: 4761623
• Report Number: 4088411
• Device Sequence Number: 1
• Product Code: MNB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/12/2014

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: 05/01/2016
• Device Catalogue Number: TC003
• Device Lot Number: HEMG05
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/08/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/12/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 36 YR
• Patient Weight: 66