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); Pressure Problem (3012)

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

Event Date 09/09/2014

Event Type  malfunction  

Event Description

A pre-teen female with a history of hypoplastic left heart syndrome who underwent staged palliation with a norwood procedure followed by a modified blalock-taussig shunt and then fontan palliation with a 20 mm extracardiac fontan.Patient had persistent cyanosis for which she had cardiac catheterization and extensive immobilization of venoatrial collateral vessels.Patient again had decreased oxygen saturations with activity and she presented a few weeks ago for cardiac catheterization and possible coil embolization of collateral vessels.During the procedure, angiogram was attempted using a power injector.High pressure tubing was used with a rating of 1200 psi to deliver a dye solution for the angiogram.During the first attempt, the pressure got only to 718 psi when the tubing's luer lock assembly fractured apart at its base causing dye solution to spray out of the tubing under pressure.A second tubing set was quickly set up and reached only 612 psi before the tubing's luer lock assembly also fractured apart at the base.A third set of tubing was obtained which reached 748 psi with the same results.High pressure tubing that comes stocked the cath lab trays (pre-packaged with drapes, suction tubing, bowls and other items), but which is often utilized initially or is utilized in a different capacity was found to work appropriately.In this case, another tray was opened to remove that tubing, which was successfully used for the angiograms.The ccl team identified that they were having problems with the brand of high pressure tubing that they ordered separately for use as extra or back-up tubing.Each package contains individually packaged tubing.The team removed all of this tubing from their supply and reported the incidents to materials management and the manufacturer was notified.They were researching other products to use as back-up tubing for the future.

• 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: 4222497
• MDR Text Key: 4972554
• Report Number: 4222497
• Device Sequence Number: 3
• 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: 09/30/2014
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: 48" 1200 PSI
• Device Catalogue Number: HPFR480K
• Device Lot Number: H379160
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2014
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES; NO.
• Patient Age: 13 YR
• Patient Weight: 31