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

Catalog Number 382006020

Device Problems Physical Resistance (2578); Device Or Device Fragments Location Unknown (2590)

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

Event Date 03/06/2017

Event Type  malfunction  

Manufacturer Narrative

A review of the device history records and inspection records was conducted and no similar concerns were found.Only the delivery catheter was returned.The length and tubing outer diameter were measured and found to be within specification.The tip of the catheter exhibited some minor kinks/dents near the tip.Indentations from where the swaged marker band was present at the tip of the catheter.The directions for use state "do not use excessive force when manipulating the catheter through an introducer.Excessive force may damage the catheter." the event description notes that the physician felt resistance.This may have placed excess strain on the catheter, damaging the radiopaque marker.The receiver for the delivery catheter lot was reviewed, and no similar concerns were noted.However, it was noted that there is a swaged band adherence to tubing shear force requirement on the drawing that could be inspected and tested for going forward.The incoming inspections will be updated to include inspection of a sample size of the snare delivery catheter devices to ensure that the band adherence meets specifications.

Event Description

Separation of radiopaque band was happened during a tevar.Atrieve vascular snare kit was used to capture a guidewire and pull through the guidewire to femoral artery.At first, the physician performed the pull through procedure in proximal area of descending aorta and the physician confirmed the radiopaque band at that time.When remove the snare from sheath, the physician felt resistance, but snare was removed successfully.Then, the physician tried to use the snare kit for the second time, the physician found that there was no radiopaque band on catheter.The procedure was stopped temporary and the physician looked for the band in operation area and inside the patient body with a fluoroscopy.However, the physician couldn¿t find the band.The physician elected to continue the procedure and completed.No health damage has been reported with this case at that time.Unsure if the radiopaque band remains in the patient or not.

• 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: 6465195
• MDR Text Key: 72259530
• Report Number: 1625425-2017-00049
• Device Sequence Number: 1
• Product Code: MMX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K021606
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/21/2021
• Device Catalogue Number: 382006020
• Device Lot Number: 11159085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2016
• 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
• Patient Age: 48 YR