MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC EBB COMPLETE TAMPONADE SYSTEM; INTRAUTERINE TAMPONADE BALLOON

Model Number CTS-1000

Device Problem Use of Device Problem (1670)

Patient Problem Miscarriage (1962)

Event Date 02/07/2020

Event Type  Injury  

Manufacturer Narrative

Pph or bleeding is fraught with potential complications and an injury is always a risk in this situation.The patient had to undergo a hysterectomy due to the uterine balloon failure after the physician pressed the balloon with his fingers after placement.Clinical innovations does not recommend pressing the balloon after correct placement has been verified.

Event Description

The ebb was used on a patient after a miscarriage in the first trimester of pregnancy.The physician used the ebb in order to stop the patient's bleeding after the miscarriage and to avoid a hysterectomy.The ebb balloon burst after the physician pressed his fingers against it.

• Brand Name: EBB COMPLETE TAMPONADE SYSTEM
• Type of Device: INTRAUTERINE TAMPONADE BALLOON
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray, ut
• Manufacturer (Section G): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray, ut
• Manufacturer Contact: kellie stefaniak ; 747 w 4170 s; murray, ut ; 2688200
• MDR Report Key: 9946644
• MDR Text Key: 196426682
• Report Number: 1722684-2020-00005
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 00814247020765
• UDI-Public: 00814247020765
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K153591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2022
• Device Model Number: CTS-1000
• Device Lot Number: 191284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention