MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC KOALA INTRAUTERINE PRESSURE CATHETER; TRANSDUCER, PRESSURE, INTRAUTERINE

Model Number	IPC-5000E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Uterine Perforation (2121)
Date of Event	03/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
In the customers words: "uterine rupture after using iupc for amnioinfusion.Iupc placed at 0254.Amnioinfusion started at 0905 300 ml bolus at rate of 999ml/hr then 50 ml/hr.Was started approximately 90 minutes prior to identification of uterine rupture.No fluid returned from amnioinfusion, abdomen palpated soft between contractions.Urgent c/s due to concern for uterine rupture, exhibited change in sve and loss of ability to find fht with external and internal monitors.Surgeon noted placental fragments and fetal head palpable extrauterine consistent with uterine rupture.Therapy duration: 1.5 hour.Uterine activity, measurement of mvus.".
Additional Manufacturer Narrative
The complaint is not confirmed because the device was not returned for evaluation and no photos were provided.Additionally, requested follow-up information from the initial reporter was not provided.Investigation description a dhr review was performed and no deviations or ncrs were found to be initiated.The risk profile below was determined by the clinical team.Item : use device for amnioinfusion.Potential failure modes: user fails to recognize that there is no fluid return during amnioinfusion potential effects: increased intrauterine volume could increase risk of uterine rupture harm: injury and/or death to fetus and/or patient severity: 4 root cause analysis a root cause could not be determined because the device was not returned for evaluation.User error and device malfunction cannot be ruled out as potential root causes.

• Brand Name: KOALA INTRAUTERINE PRESSURE CATHETER
• Common Device Name: TRANSDUCER, PRESSURE, INTRAUTERINE
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• Manufacturer (Section G): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• Manufacturer Contact: zulmar molina ; 747 w 4170 s; murray, UT 84123 ; 8012606086
• MDR Report Key: 19230704
• Report Number: 1722684-2024-00008
• Device Sequence Number: 20250292
• Product Code: HFN
• UDI-Device Identifier: 00814247020178
• UDI-Public: 00814247020178
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K974389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

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: 11/30/2025
• Device Model Number: IPC-5000E
• Device Lot Number: 231411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown