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

Catalog Number 382006010

Device Problem Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/07/2018

Event Type  malfunction  

Manufacturer Narrative

The review the device history record and inspection record and no similar concerns were found.A review of the returned product was performed.Visual inspection noted that the radiopaque (marker band) was missing from the delivery catheter, and the complaint was confirmed.The delivery catheter is purchased from a supplier.The supplier has been notified of the issue and a follow-up report will be provided when the supplier provides a root cause and corrective action.

Event Description

Atrieve vascular snare kit was inserted into the 6fr destination guiding sheath and pull in the 0.014 inch guidewire successfully.During procedure, through the angiography image, the physician found that the radiopaque band on the atrieve kit catheter was left on the patient¿s left deep artery of thigh.The physician tried to remove the radiopaque band using balloon catheter, but it failed.The physician elected to let the radiopaque band remain in the patient's body and complete the procedure.No health damage has been reported with this case at that time.

Manufacturer Narrative

The device history records and inspection records were reviewed and no similar concerns were found.A review of the returned product was performed.Visual inspection noted that the radiopaque (marker band) was missing from the delivery catheter, and the complaint was confirmed.The delivery catheter is purchased from a supplier.The supplier was notified of the issue and they conducted an investigation.The supplier conducted a robust root cause analysis, but the cause of the event was not identified.Some of the areas reviewed for the root cause analysis included the materials used, the equipment used, the methods used, personnel factors involved, any associated maintenance, and the environment.There was no root cause identified, as well as no issue noted during the entire manufacturing process.

• Brand Name: ATRIEVE VASCULAR SNARE
• Type of Device: VASCULAR SNARE
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek road; athens TX 75751
• MDR Report Key: 8244488
• MDR Text Key: 133189925
• Report Number: 1625425-2018-00211
• Device Sequence Number: 1
• Product Code: MMX
• Combination Product (y/n): Y
• PMA/PMN Number: K021606
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 382006010
• Device Lot Number: 11158631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention