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

Model Number	CTS-1000
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Miscarriage (1962)
Date of Event	02/07/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: INTRAUTERINE TAMPONADE BALLOON
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray, ut
• MDR Report Key: 9946644
• Report Number: 1722684-2020-00005
• Device Sequence Number: 2916685
• Product Code: OQY
• UDI-Device Identifier: 00814247020765
• UDI-Public: 00814247020765
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K153591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2020

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?: No
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention