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

Model Number	IPC-5000E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Head Injury (1879); Laceration(s) (1946)
Date of Event	08/29/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
We are investigating this event and trying to gather more information.If any additional information is received, a follow-up report will be submitted.
Event or Problem Description
The reporter stated the 27.6/7 gestation sustain 10.4 cm.Laceration all the way down to her skull while she is in his mother's womb.Mom had premature rupture of membranes and admitted to the hospital, and she developed chorio.The attending ob physician ordered iupc, multiple insertion attempts by the resident and a fellow failed.Mom's vagina was covered with frank blood.The baby was delivered by caesarean section at 11:50 pm in (b)(6) hospital by emergency c-section.The baby was admitted on (b)(6) 2022 and expired on (b)(6) 2022.The autopsy diagnosis was bacterial meningitis.The baby with scalped at the time of delivery.The baby was delivered 2 hours later, and the laceration was discovered.The ultrasound confirmed the injury occurred while baby is in his mother's womb.

• Brand Name: KOALA INTRAUTERINE PRESSURE CATHETER
• Common Device Name: KOALA
• 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: thomas hirte ; 747 w 4170 s; murray, UT 84123 ; 8012688200
• MDR Report Key: 21048361
• Report Number: 1722684-2024-00016
• Device Sequence Number: 15553212
• Product Code: HFN
• UDI-Device Identifier: 00814247020178
• UDI-Public: 00814247020178
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/31/2024

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 Model Number: IPC-5000E
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown