MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 11.F X 15CM DUO-FLOW IJ CATHETER; DUO-FLOW IJ SHORT TERM HEMODIALYSIS CATHETER

Model Number	XTP116IJS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hematoma (1884)
Date of Event	06/03/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
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 had aortic valve replacement and coronary bypass surgery on (b)(6) 2021.Post operatively in the critical care unit, he presented with deterioration of kidney function.On (b)(6) 2021 a percutaneous dialysis catheter was inserted through ultrasound-guided right internal jugular vein, to perform dialysis.After insertion, patient sits down.Hemodynamically and respiratory stable.When starting dialysis, air aspiration was observed through one of the lights.On chest radiography, the catheter appears to be normalized, so it was decided to remove it and insert a new one.After removing the catheter, the patient presented rapid clinical deterioration, with cardiac arrest.Resuscitation maneuvers and emergent sternotomy revealed the existence of a large hematoma in the right hemothorax.Regulated surgical revision was performed, no vascular lesion was observed, nor new bleeding.Unfavorable subsequent evolution, with cerebral hypoxia, and death two days later.
Additional Manufacturer Narrative
The device involved in the incident was unavailable for evaluation.The facility reporting the incident was unable to provide the lot number of the device.A review of the manufacturing records was not possible.The report indicated that after removing the catheter the patient presented rapid clinical deterioration and cardiac arrest.An emergent sternotomy revealed the existence of a large hematoma in the right hemothorax (right of the heart and mediastinum).The catheter had been inserted into the right internal jugular vein.Literature states that hematoma and venous puncture are common complications that can occur during catheterization.The patient was post aortic valve replacement.The use of anticoagulants are common post valve replacement.This may have contributed to bleeding and the formation of the hematoma.The hospital did not establish a direct link between the device and the event.Instructions for use include the following potential complications: hemorrhage, inferior vena cava puncture, laceration of vessel, perforation of vessel, superior vena cava puncture.

• Brand Name: 11.F X 15CM DUO-FLOW IJ CATHETER
• Common Device Name: DUO-FLOW IJ SHORT TERM HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 12087683
• Report Number: 2518902-2021-00032
• Device Sequence Number: 19670138
• Product Code: MPB
• UDI-Device Identifier: 00884908059144
• UDI-Public: 884908059144
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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: Other
• Device Model Number: XTP116IJS
• Device Catalogue Number: XTP116IJS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 07/23/2021
• 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: Death
• Patient Age: 74 YR
• Patient Weight: 85