MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. ATRIEVE VASCULAR SNARE

Catalog Number 381003004

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/26/2017

Event Type  malfunction  

Manufacturer Narrative

There were no samples or images available for review and a lot number was not provided.Without the sample to review, a definite root cause and corrective action cannot be established.Since a lot number was not provided, a review of the device history record and inspection records could not be conducted.This product is not intended for use in the brain, but is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects.

Event Description

The doctor was using the atrieve snare in the brain the radiopaque band fell off and remained in brain.

• Brand Name: ATRIEVE VASCULAR SNARE
• Type of Device: VASCULAR SNARE
• 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: 7054750
• MDR Text Key: 93690582
• Report Number: 1625425-2017-00154
• Device Sequence Number: 1
• Product Code: MMX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021606
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 381003004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other