MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-21 for AFFIRM BREAST BIOPSY GUIDANCE SYSTEM STLC-00004 manufactured by Hologic, Inc.
[136988332]
The stereotactic biopsy attempt failed to target the area of interest of calcifications with 2 attempts. An attempt was made in the superior approach to the breast tissue. Tissue was extracted and x-rayed with no calcifications being seen in the samples. The patient was then repositioned in the lateral medial approach. Tissue was extracted and x-rayed with no calcifications seen in the sample again. The patient was then sent to ultrasound to attempt sampling of the area and was successful. The quality control for the stereotactic was performed the morning of the procedure per protocol passed with no issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8358891 |
| MDR Report Key | 8358891 |
| Date Received | 2019-02-21 |
| Date of Report | 2019-02-15 |
| Date of Event | 2019-02-11 |
| Report Date | 2019-02-15 |
| Date Reported to FDA | 2019-02-15 |
| Date Reported to Mfgr | 2019-02-21 |
| Date Added to Maude | 2019-02-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AFFIRM BREAST BIOPSY GUIDANCE SYSTEM |
| Generic Name | SYSTEM, X-RAY, MAMMOGRAPHIC |
| Product Code | IZH |
| Date Received | 2019-02-21 |
| Model Number | STLC-00004 |
| Catalog Number | STLC-00004 |
| Device Availability | Y |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 36 APPLE RIDGE ROAD DANBURY CT 06810 US 06810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-21 |