MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-10-02 for HAWKINS III BREAST LOCALIZATION NEEDLE UNK manufactured by Angiotech Medical Device Tech.
[934450]
The dr. Used a breast localization needle (they believe it was a hawkins iii? ) for marking a lung lesion in 2006. The pt recently came to the hosp with the main complaint of feeling that something was wrong with his chest. As the result of ct scanning, it was identified that there is a remaining of metal wire (? ) in the muscle layer of the pt. The doctor said the hook wire was inserted from the back of the pt. He missed to place the hook in the target area in the lung, and the hook portion hung down in the back side plural cavity. He cut the flexstrand wire at outside of the body. The surgical operation was performed in four hours. According to the doctor's memory, he pulled the hookwire out from the plural cavity side by force during the operation.
Patient Sequence No: 1, Text Type: D, B5
[8261600]
We received info from our customer concerning a procedure that was completed in 2006. The pt returned to the office in 2008 complaining of pain in the chest. The doctor then completed a ct and found the wire in the muscle tissue. Since the procedure was in 2006, there is no device sample available for sample, they also are unsure of the part number/lot number that was involved. They believe the device used was a hawkins breast needle, which was used for a lung lesion. There is a caution statement that is sent with the device that states the product line is for use on breast tissue. The catalog states the product line is "for temporary fixation (of the wire) during a confirming mammogram" in which the wire is then removed afterwards with the lesion/tissue that was marked from the breast tissue. We have no other incidents reported in our complaint database for metal wire remaining in the patient's body for this product line. The caution statement also states for the customer not to cut the wire, during the procedure, the doctor remembers cutting the flexstrand wire outside the body, because he missed the target area in the lung he was going for and the hook portion lung down in the back side of the plural cavity. The doctor also remembers pulling the hook wire from the plural cavity with force during the operation using forceps. The incident was caused by customer misuse, they used a breast needle for a lung procedure, but the wire when instructed not to, and also pulled with force.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036710-2008-00008 |
| MDR Report Key | 1187083 |
| Report Source | 07 |
| Date Received | 2008-10-02 |
| Date of Report | 2008-10-01 |
| Date Mfgr Received | 2008-09-12 |
| Date Added to Maude | 2010-06-12 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Street | 3600 S.W. 47TH AVE. |
| Manufacturer City | GAINESVILLE FL 32608 |
| Manufacturer Country | US |
| Manufacturer Postal | 32608 |
| Manufacturer Phone | 3523380440 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAWKINS III BREAST LOCALIZATION NEEDLE |
| Generic Name | HAWKINS BLN |
| Product Code | MIJ |
| Date Received | 2008-10-02 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIOTECH MEDICAL DEVICE TECH |
| Manufacturer Address | GAINESVILLE FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-10-02 |