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); Laceration(s) (1946)
Date of Event	04/24/2021
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
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.
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 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.

• 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: 12086590
• Report Number: 2518902-2021-00031
• Device Sequence Number: 11600155
• 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: 69 YR
• Patient Weight: 69