MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. ACCURA BLN; BREAST LOCALIZATION NEEDLE (BLN)

Catalog Number BLN20075

Device Problems Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)

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

Event Date 08/31/2016

Event Type  malfunction  

Manufacturer Narrative

A review of the device history records and inspection records was conducted and no similar concerns were found.The product not returned for evaluation, but images of the wire were provided by the customer.Bln20075 wires and needles were pulled from inventory.Two wires were inserted into two separate needles.Each wire was inserted into a needle and pushed to a deployed position.From the deployed position, the wire was pulled back into needle.This caused the barb to straighten and damaged the wire.This device is a non-repositionable bln wire, so damage is expected if the wire is retracted after deployment.Comparison between the wires tested from inventory and the images sent by customer show similarities in appearances of the wires.Since the issue was able to replicated by retracting the non-repositionable wire after it was deployed, this issue is not likely a manufacturing issue.

Event Description

Breast localization under mammography.2 wires placed in breast, 1st wire moved and 2nd wire looked stable on completion of examination.Surgery has to be repeated as wire moved again and not all calcification was removed.

• Brand Name: ACCURA BLN
• Type of Device: BREAST LOCALIZATION NEEDLE (BLN)
• 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: 6113692
• MDR Text Key: 60856842
• Report Number: 1625425-2016-00088
• Device Sequence Number: 1
• Product Code: GAA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K974741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Catalogue Number: BLN20075
• Device Lot Number: 11131139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2016
• 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