MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. CONTRAST INJECTION HIGH PRESSURE TUBING; DISPLAY, CATHODE-RAY TUBE, MEDICAL, HIGH PRESSURE TUBING

Model Number 48" 1200 PSI

Device Problems Fracture (1260); Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/11/2014

Event Type  malfunction  

Event Description

Male pre-schooler with history of hypoplastic left heart syndrome diagnosed in utero, with coronary artery to left ventricular fistulae.He had undergone multiple cardiac surgeries including coil closure of the fistulae, norwood/sano procedures, bidirectional glenn procedure with banding of the right ventricle to pulmonary artery conduit, atrial septectomy and tricuspid valve repair for tricuspid regurgitation.The patient was undergoing a right and left heart catheterization procedure with angiography and possible coil embolization of significant venovenous or aortopulmonary collateral vessels.The high-pressure iv tubing was hooked up to the power-injector pump system to deliver the dye solution for angiography; the pump reached 852 psi when the tubing fractured at the luer-lock connection to the patient's iv line.The luer lock assembly came apart from the base.A second set of tubing was prepared, and when infusion was started, it reached 677 psi when the luer connector came apart at the same place.Tubing is listed as capable of administering up to 1200 psi.

• Brand Name: CONTRAST INJECTION HIGH PRESSURE TUBING
• Type of Device: DISPLAY, CATHODE-RAY TUBE, MEDICAL, HIGH PRESSURE TUBING
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 4151070
• MDR Text Key: 19555617
• Report Number: 4151070
• Device Sequence Number: 1
• Product Code: DXJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/29/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 48" 1200 PSI
• Device Catalogue Number: HPF480K
• Device Lot Number: H427832
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OF DYE SOLUTION.; NO OTHER THERAPIES; THE TUBING WAS FOR HIGH-PRESSURE ADMINISTRATION; PATIENT WAS HAVING A HEART CATHETERIZATION, AND
• Patient Age: 46 MO
• Patient Weight: 15