MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. V-MARK BREAST BIOPSY SITE MARKER

Catalog Number 766914100SST

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record was performed and no similar concerns were found.The investigation is currently on-going.Once the investigation is complete, a follow-up report will be submitted.

Event Description

After the procedure, the radiology noticed that the titanium marker (inside the needle) had come out with the needle and stuck to the skin of the patient.She had to sever the marker from the skin.

Manufacturer Narrative

Eight samples were returned for evaluation.Four of the samples were returned open and four sample were fully sealed in the returned package.One of the open samples had the titanium anchor missing from the polymer plug.The other three opened samples had the marker/titanium anchor visible in the v-mark needle and no issues were noted.No issues were noted with the four devices that were received unopened.The exact root cause is unable to be determined, but a possible cause of this issue is that the device was exposed to temperatures above 45°c (the label states this temperature limit) after leaving the manufacturing facility.Temperature in excess of 45°c affects the bioabsorbable polymer plug and may have caused the titanium anchor to separate.The temperature limit is currently stated on the label of the device.No additional corrective action will be taken at this time since the issue occurred after leaving the manufacturing facility.

• Brand Name: V-MARK BREAST BIOPSY SITE MARKER
• Type of Device: BREAST BIOPSY SITE MARKER
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek road; athens TX 75701
• MDR Report Key: 7601540
• MDR Text Key: 111895343
• Report Number: 1625425-2018-00064
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): Y
• PMA/PMN Number: K053518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 766914100SST
• Device Lot Number: 11209176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• 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