MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. HOMER BLN; BREAST LOCALIZATION NEEDLES

Device Problems Signal Artifact/Noise (1036); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/09/2017

Event Type  Injury  

Manufacturer Narrative

The actual device was not returned; however, the customer provided an image and identified the foreign body in the radiopaque image.A member of argon's clinical team was consulted, and he stated "it is difficult to conclude the origin of the foreign body without analyzing the introductory needle as well as the bln itself to see if any bit of it sheared off inside of the patient.Based on the radiopacity, it most certainly is metallic in nature.That being stated, you would need to see the bln and introducer needs to make a definitive correlation".

Event Description

Needle loc performed on (b)(6) 2017.On monogram after needle loc a 0.8mm triangular foreign body present on mri causes artifact.

Manufacturer Narrative

Sample device was returned for evaluation, only the bln needle and not the introducer.It is difficult to conclude the origin of the foreign body without analyzing the introductory needle as well as the bln itself to see if any bit of it sheared off inside of the patient.A root cause cannot be conclusively determined.The complaint could not be confirmed so a corrective action will not be taken at this time.

• Brand Name: HOMER BLN
• Type of Device: BREAST LOCALIZATION NEEDLES
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek road; athens TX 75751
• MDR Report Key: 8750178
• MDR Text Key: 149706084
• Report Number: 1625425-2019-00186
• Device Sequence Number: 1
• Product Code: GAA
• Combination Product (y/n): Y
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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): Other