MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. TRIO-CT TRIPLE LUMEN CATHETER

Model Number	AS01135201
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Embolism/Embolus (4438)
Date of Event	03/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The 13.5 x 20cm trio ct catheter was returned for evaluation.Visual inspection revealed no obvious defects.A functional test was performed by clamping the distal end of the lumen with hemostats and flushing water through each of the three luers.No leaks were noted.The hemostats were removed, the clamps closed, and an attempt was made to aspirate through each of the luers but the clamps held.No problem found with the returned device.Additional information was provided by sales rep after discussing event with the facility reporter."it is highly unlikely that there is an issue with the catheter.The patient has a medcomp trio catheter and a g-tube in and obtained an air embolism.It is believed that the wrong line was accessed, as both the trio catheter 3rd lumen and the g-tube are purple in color, and it may have been a user error scenario.The patient coded but was successfully resuscitated.".Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Patient was to have a ct guided g-tube placement.During scout film, an air embolus was detected in the right ventricle.Patient was immediately removed from the ct table and the g-tube placement was deferred.Patient was placed in left lateral decubitus position, place on 100% oxygen nonrebreather, and attempts made to aspirate the air via the patient's indwelling hemodialysis catheter.Patient became increasingly hypoxic and deteriorated with loss of pulse.Code was immediately called.Patient survived.Mentation appropriate and following commands.

• Brand Name: TRIO-CT TRIPLE LUMEN CATHETER
• Common Device Name: TRIO-CT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 19098424
• Report Number: 2518902-2024-00022
• Device Sequence Number: 7408555
• Product Code: MPB
• UDI-Device Identifier: 00884908133219
• UDI-Public: 00884908133219
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K183219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: AS01135201
• Device Catalogue Number: AS01135201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 88 YR
• Patient Sex: Female
• Patient Weight: 76 KG