FDA Adverse Event
Other
Summary report: N
ATEC VACUUM ASSISTED BREAST BIOPSY DEVICE
MDR report key: 1155952
·
Received September 5, 2008
Report
- Report Number
- 3003862400-2008-00007
- Event Type
- Other
- Date Received
- September 5, 2008
- Date of Event
- July 31, 2008
- Report Date
- August 28, 2008
- Manufacturer
- HOLOGIC INC. - INTERVENTIONAL BREAST SOLUTIONS DIVISION
- Product Code
- KNW
- PMA / PMN Number
- K042290
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT AFTER USING AN ATEC 1212-20 DEVICE, THEY WENT TO PLACE A MARKER INSIDE THE PATIENT'S BREAST AND FELT UNKNOWN RESISTANCE. ACCORDING TO THE CUSTOMER, X-RAY CONFIRMS THE TIP OF THE ATEC 1212-20 NEEDLE BECAME DETACHED AND IS STILL INSIDE THE BREAST OF THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATEC VACUUM ASSISTED BREAST BIOPSY DEVICE | VACUUM ASSISTED CORE BIOPSY DEVICE | KNW | HOLOGIC INC. - INTERVENTIONAL BREAST SOLUTIONS DIVISION | ATEC 1212-20 | 806004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |