MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2014-08-01 for HAWKINGS XXX BLN (BREAST LOCALIZATION NEEDLES) 253075 manufactured by Argon Medical Devices, Inc..
[21449290]
The patient had an elective breast localization procedure prior to surgery for the removal of a previously diagnosed breast cancer. A guidewire was placed in the breast tumor under ultrasound imaging guidance. Following the procedure, the patient complained of pain under her right arm and experienced some shortness of breath. The patient underwent a post localization mammogram which demonstrated some movement of the wire into the breast with the distal end visible but the proximal end, with the hooked barb, not visible. Two chest x-rays were taken and the wire appeared to be within the breast tissue, but had migrated further into the breast, so that there was no wire visible on the external skin surface. After surgery for removal of the tumor, the post-operative ct scan demonstrated a small pneumothorax and the original wire to be lying within the chest with the barbed hook end in the outer aspect of the right upper lung lobe and the free end in the pleural cavity. The patient returned six days later with some chest pain. A ct scan demonstrated no movement of the wire but the free end to have moved within the pleural cavity. The original localizing wire was successfully removed on the 13th day.
Patient Sequence No: 1, Text Type: D, B5
[21616567]
It was reported by the customer that the product had been in use for some years in the trust with no incident and there was no suspicion of any defect with the device. The complaint device was not returned for analysis. The lot number was not provided; therefore, the dhr could not be reviewed. An investigation of this incident was performed by the hospital clinical team. Per their investigation, contributory factors related to this complaint were: the relative inexperience of the operator which contributed to the placement of the tip of the localization needle and wire within the chest wall. ; the position of the lesion within the breast close to the chest wall was a contributory factor in the placement of the tip of the needle and wire with the chest wall; omission of the clip supplied within the localization pack for securing to the distal end of the wire after positioning, was not a contributory factor to the chest wall penetration although this could have avoided complete migration of the wire into the chest. The hospital concluded that the fundamental underlying factor that contributed to the incident was the fact that penetration of the chest wall during a needle wire localization is a recognized complication of this procedure. In this case, the lesion was partially close to the chest wall. The essential design requirements (doc. Pl-018 of dhf) were reviewed and verified by all appropriate departments at argon medical devices, inc. The skin clip is used to prevent migration during patient transport. It was not in this incident. The fema ws reviewed and migration is not included as failure mode, thus numerical risk calculation is not determined. Risk/failure mode analysis and design verification and validation requirements were met. It is stated in the risk management plan that the user should be experienced in procedures using breast localization needles. The hawkins iii bln, (b)(4) has been on the market since before 1997 with no other related complaints regarding migration of the needle from the breast to the lung.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1625425-2014-00021 |
| MDR Report Key | 4487552 |
| Report Source | 07,08 |
| Date Received | 2014-08-01 |
| Date of Report | 2014-07-31 |
| Date of Event | 2013-08-06 |
| Date Mfgr Received | 2014-07-02 |
| Date Added to Maude | 2015-02-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GAIL SMITH |
| Manufacturer Street | 1445 FLAT CREEK ROAD |
| Manufacturer City | ATHENS TX 75751 |
| Manufacturer Country | US |
| Manufacturer Postal | 75751 |
| Manufacturer Phone | 9036764209 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAWKINGS XXX BLN (BREAST LOCALIZATION NEEDLES) |
| Generic Name | BIOPSY NEEDLE |
| Product Code | DWO |
| Date Received | 2014-08-01 |
| Catalog Number | 253075 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES, INC. |
| Manufacturer Address | ATHENS TX 75751 US 75751 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-08-01 |