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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Hematoma (1884)

Event Date 06/03/2021

Event Type  Death  

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 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.

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
• Type of Device: DUO-FLOW IJ SHORT TERM HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 12087683
• MDR Text Key: 259029169
• Report Number: 2518902-2021-00032
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00884908059144
• UDI-Public: 884908059144
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Model Number: XTP116IJS
• Device Catalogue Number: XTP116IJS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 06/29/2021
• Supplement Dates Manufacturer Received: 06/29/2021
• Supplement Dates FDA Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Weight: 85