MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. NON-BRAIDED HIGH PRESSURE LINE; CATHETER, DIAGNOSTIC, INTRAVASCULAR

Model Number	77-301607
Health Effect - Clinical Code	Death (1802)
Date of Event	01/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: the samples returned by the customer were tested and no air bubbles or leaks were found.Corrective action: due to the root cause determination, a corrective action has not been taken.Investigation summary: an internal complaint ((b)(4)) was received indicating that an end user could not remove air bubbles from two high pressure lines from the same lot number.The patient reportedly died, but the end user stated the patient's death was not caused by the high pressure lines.The defective samples were returned to the manufacturing facility where they were analyzed.The samples were purged with a bleach/water solution and then placed in a batch of bleach/water solution overnight.The lines were then cleaned and dried for visual inspection, which they paced.The tapers on the connectors were verified and met specification.Using a hydrostatic tester, the lines were pressurized to 200psi and checked for signs of leakage.No leaks were seen.The lines were pressured to 600psi for 10 seconds and 1,000psi for 10 seconds with no failures.One line was taken and pressurized until it burst.No leakage was seen and the line burst at 1,080psi.Customer complaints were reviewed for similar reports.No similar reports were identified.From january 3, 2017 to january 9, 2019, deroyal has sold (b)(4) cases or (b)(4) each.The investigation is complete at this time.If new and critical information is received, this report will be updated.
Event or Problem Description
The end user was unable to remove air bubbles from two high pressure lines from the same lot number.A third line was opened from a different lot number to complete the case.The product was being used on a power injector during a heart catheterization procedure.The patient died; however, the end user stated the high pressure line did not cause the patient to decease as the patient suffered many health issues.

• Brand Name: NON-BRAIDED HIGH PRESSURE LINE
• Common Device Name: CATHETER, DIAGNOSTIC, INTRAVASCULAR
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 8310102
• Report Number: 3005011024-2019-00001
• Device Sequence Number: 16678851
• Product Code: DQO
• UDI-Device Identifier: 00749756168847
• UDI-Public: 00749756168847
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K023591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 77-301607
• Device Lot Number: 48339425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 02/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1