MAUDE Adverse Event Report: UTAH MEDICAL PRODUCTS, INC. BT CATH BALLOON TAMPONADE CATHETER; INTRAUTERINE TAMPONADE BALLOON

Catalog Number BTC-100

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/13/2018

Event Type  malfunction  

Event Description

Pt with postpartum hemorrhage, utah tamponade device which was the only balloon available on the labor floor.This was placed postpartum and expulsion.A second was placed and also displaced into the cervix and not effective.Pt had persistent hemorrhage due to ineffective available tamponade balloon and required bilateral uterine artery embolization.Amount of blood loss is unknown.

• Brand Name: BT CATH BALLOON TAMPONADE CATHETER
• Type of Device: INTRAUTERINE TAMPONADE BALLOON
• Manufacturer (Section D): UTAH MEDICAL PRODUCTS, INC.; 7043 south 300 west; midvale UT 84047
• MDR Report Key: 7881289
• MDR Text Key: 120435774
• Report Number: 7881289
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: BTC-100
• Device Lot Number: 1170951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other