MAUDE Adverse Event Report: ARGON MED DEVICES, INC ARGON 8FR ONE PIECE TUOHY-BORST CATHETER INTRODUCER; 8FR PERCUTANEOUS INTRODUCER

Model Number 796134

Device Problems Defective Component (2292); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Information (3190)

Event Date 07/01/2014

Event Type  malfunction  

Event Description

Opened sheath for cardiac cath lab procedure.Sheath with visible defect of slice through the center of it.No dilator or wire in the package.This was immediately take off of the filed and another opened for procedure.Diagnosis or reason for use: cardiac catheterization procedure.

• Brand Name: ARGON 8FR ONE PIECE TUOHY-BORST CATHETER INTRODUCER
• Type of Device: 8FR PERCUTANEOUS INTRODUCER
• Manufacturer (Section D): ARGON MED DEVICES, INC; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 3949874
• MDR Text Key: 4601596
• Report Number: MW5037335
• Device Sequence Number: 1
• Product Code: DQY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2018
• Device Model Number: 796134
• Device Lot Number: 11056493
• Other Device ID Number: H911496134OA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1