MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ONE PIECE/TUOHY-BORST CATHETER INTRODUCER

Model Number	496132
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was returned and evaluated.The introducer was confirmed to be in two pieces with straight edges that are indicative of a cut using a sharp instrument.The cut was at an angle approximately where the sheath would pass through the skin.Since the alleged complaint was most likely the result of an event within the user environment, no corrective action will be taken at this time.
Event or Problem Description
The step of procedure: 1.Insert needle to the femoral vein , 2.Insert guidewire, 3.Remove needle, 4.Insert sheath, 5.Remove guidewire and dilator, 6.The dr.Hold the body of sheath (near valve) prepare to insert tubing, but he found the sheath was broken and the broken parts was shifted near to right atrium.It was taken out by snare.

• Brand Name: ONE PIECE/TUOHY-BORST CATHETER INTRODUCER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10075707
• Report Number: 1625425-2020-00326
• Device Sequence Number: 2861731
• Product Code: DRE
• UDI-Device Identifier: 00886333213597
• UDI-Public: 00886333213597
• Combination Product (Y/N): N
• PMA/510(K) Number: K780126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2020

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 Expiration Date: 11/18/2024
• Device Model Number: 496132
• Device Catalogue Number: 496132
• Device Lot Number: 11284027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1