MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. TRIPLE-LOOP SNARE RETRIEVAL KIT

Catalog Number 380911330

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 02/04/2020

Event Type  Injury  

Manufacturer Narrative

The device was intended for demo use only.An argon territory sales manager did not realize that the device was non-sterile and gave it to north shore university hospital as a sample product where it was used in a procedure on a patient.The hospital was notified immediately after the argon territory sales manager became aware that the device was not for clinical use on (b)(6) 2020.The patient was placed on an antibiotic regimen to prevent potential infection.This product had not yet been distributed, only used for sales demonstration.All other devices that had been given to sales managers were immediately unpackaged to prevent clinical use by mistake.The root cause has been determined as insufficient indication of packaging for devices intended for demo use only.The caution label for demo device packaging was only on the inside package, not the outside packaging for obvious visibility.

Event Description

On (b)(6) 2020 i brought a filter retrieval set into (b)(6).I was unaware that the product wasn¿t sterile.The triple loop snare was the only part of the kit that was used on the patient.As soon as i was aware the product wasn¿t sterile, i reported it to the hospital.

• Brand Name: TRIPLE-LOOP SNARE RETRIEVAL KIT
• Type of Device: RETRIEVAL KIT
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek road; athens TX 75751
• Manufacturer (Section G): ARGON MEDICAL DEVICES INC.
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 9740555
• MDR Text Key: 189297446
• Report Number: 1625425-2020-00175
• Device Sequence Number: 1
• Product Code: MMX
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K191758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/01/2005,02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 380911330
• Device Lot Number: 11291204
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other