MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. HAWKINS II BLN (BREAST LOCALIZATION NEEDLE); NONE

Catalog Number 242050

Device Problems Break (1069); Difficult to Advance (2920)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/01/2014

Event Type  Injury  

Event Description

Dr inserted the needle into the pt under fluoroscopy to introduce the hawkins ii needle, hook/wire.He advanced the wire to the tip of the needle and backed the wire/hook up, thus to take one final placement marking and prepare for the hook of the wire to be inserted into the mass of the breast with the wire hanging out of the pt.When the wire was being pulled back, the wire came apart from the hook portion of the total hook/wire device and the doctor was left holding the wire (no hook) in his hand.Dr (b)(6) then set the wire portion aside and opened another hawkins ii needle package and used the second wire/hook portion to advance down the previous needle.The new wire/hook end was met with resistance.Dr (b)(6) then advanced the second hook/wire and pushed the detached hook into the pt.The second wire was inserted into the pt, so the mass could be marked or removed.The hook could not be located within the pt and the pt was taken to the operating room for removal of the hook.

Manufacturer Narrative

A review of the device history record did not reveal any related deviations or abnormalities for the complaint lot number 11063213.There was one other similar complaint for this product from the same doctor.Before these two complaints, there were no other prior similar complaints for lot 11063213 or 1106182 which both contained the same sub (wire) lot.The root cause of the breakage of the breast localization needle was not determined.The returned needle was broken.Complaints will continue to be monitored for trends.

• Brand Name: HAWKINS II BLN (BREAST LOCALIZATION NEEDLE)
• Type of Device: NONE
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; athens TX
• Manufacturer Contact: gail smith ; 1445 flat creek rd.; athens, TX 75751 ; 9722102562
• MDR Report Key: 3877787
• MDR Text Key: 4589953
• Report Number: 1625425-2014-00018
• Device Sequence Number: 1
• Product Code: GDM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K870523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 242050
• Device Lot Number: 11063213
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/02/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/27/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR