MEDICAL COMPONENTS, INC. 11.F X 15CM DUO-FLOW IJ CATHETER; DUO-FLOW IJ SHORT TERM HEMODIALYSIS CATHETER
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Model Number XTP116IJS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Arrest (1762); Laceration(s) (1946)
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Event Date 04/24/2021 |
Event Type
Death
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Manufacturer Narrative
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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.
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Event Description
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Critical patient, sedated and on mechanical ventilation, with mediastinal drainage.Ultrasound-guided puncture in the left internal jugular vein.Insertion of catheter without apparent incidents.Venous blood reflux through both lumens of the catheter.Sealed with 1% heparin.Mobilization and hygiene of the patient is carried out.Two hours later, before starting therapy, massive bleeding from the mediastinal drains, with cardiac arrest.Emerging sternotomy, innominate vein laceration is observed.
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Manufacturer Narrative
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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 prior to catheter insertion the patient was having mediastinal drainage.The patient experienced massive bleeding from the mediastinal drains two hours after catheter insertion, in the left internal jugular vein, before starting therapy.The patient experienced cardiac arrest and during an emergent sternotomy innominate vein laceration was noted.The left and right brachiocephalic veins (or innominate veins) are major veins in the upper chest, formed by the union of each corresponding internal jugular vein and subclavian vein.Literature states that the left innominate vein may be torn during median vertical sternotomy.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.
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