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

Catalog Number 382006020

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tricuspid Regurgitation (2112)

Event Date 04/12/2017

Event Type  Injury  

Manufacturer Narrative

There were no samples or images returned for review; however, a lot number was provided.A review of the device history records and inspection records was conducted and no similar concerns were found.Without the sample to review, a definite root cause and corrective action cannot be established.If the sample is returned at a future date, the complaint will be reopened for further evaluation.The complaint was reported to argon through another device manufacturer (spectranetics corporation).Per the email correspondence, "one of our spectranetics corporation sales reps was at a lead management case where an ae occurred and an argon medical device may have been involved." a part number and lot number was provided, but spectranetics is "not sure if this is the exact device, model, or lot #." the reported customer has not responded to any of the requests from argon.Based on the event description provided, it appears that the atrieve vascular snare was being used to remove leads that were attached to the heart.Per the atrieve instructions for use provided with this product, one of the warnings states, "this device is not intended for removal of implanted pacing leads.".

Event Description

Initial narrative: (b)(6) woman post complicated extraction of co-radial atrial and ventricular leads including need for femoral lead extraction.Postoperative day 1 noted to have hypotension and found to have severe tricuspid regurgitation secondary to avulsion of the tricuspidvalve.She was sent for valve replacement for tr.In further conversation with the sales rep, it was reported that the physician thought that femoral snares were suspect in contributing to the tricuspid injury.

• 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: 6578246
• MDR Text Key: 75546974
• Report Number: 1625425-2017-00075
• 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: other
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/01/2021
• Device Catalogue Number: 382006020
• Device Lot Number: 11151864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2016
• 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): Required Intervention
• Patient Age: 71 YR