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

Model Number IPC-5000E

Device Problem Inadequate User Interface (2958)

Patient Problem Bruise/Contusion (1754)

Event Type  Injury  

Manufacturer Narrative

The koala catheter is specifically designed to be as atraumatic as possible, thus such an incident is extremely rare over its 20+ year history.An internal investigation of the incident concluded that the most likely root cause is the inadvertent advancement of the introducer beyond the opening of the cervix, as this is the only material that is stiff enough to potentially cause trauma to the fetus.The distributor will provide training to the hospital to stress the point that the introducer should not advance the providers fingers placed at the cervical opening.If any additional information is received, a follow-up report will be sent.

Event Description

A baby had a "bruised" scar in the face after delivery and the parents sharply complained about it to the hospital.

• Brand Name: KOALA IUPC INTRAUTERINE PRESSURE CATHETER
• Type of Device: 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: kellie stefaniak ; 747 w 4170 s; murray, UT 84123 ; 8012688200
• MDR Report Key: 9541191
• MDR Text Key: 173724479
• Report Number: 1722684-2020-00001
• Device Sequence Number: 1
• Product Code: HFN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K974389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: IPC-5000E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other