MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. ARTERIAL CATHETER MINI-KIT; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number 498101

Device Problems Kinked (1339); Incorrect Measurement (1383); Product Quality Problem (1506)

Patient Problem No Information (3190)

Event Date 04/18/2018

Event Type  malfunction  

Event Description

During elective transcatheter aortic valve replacement (tavr) the anesthesiologist started using a left arterial line catheter but the catheter appeared to have been cut off too short during manufacturing possibly ¿ the catheter was also kinking multiple areas so anesthesiologist aborted use of this catheter and used a new one, which had no problems.Same doctor stated last week she used one of these same catheters that had what appeared to be a burr tip but no packaging was saved.

• Brand Name: ARTERIAL CATHETER MINI-KIT
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek rd.; athens TX 75751
• MDR Report Key: 7486485
• MDR Text Key: 107352375
• Report Number: 7486485
• Device Sequence Number: 1
• Product Code: GDY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/19/2022
• Device Model Number: 498101
• Device Catalogue Number: 498101
• Device Lot Number: 11201531
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 87