MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-01-15 for MULTICARE PLATINUM 8-004-0017 manufactured by Hologic, Inc.
[133054874]
It was reported that during a biopsy the system never alarmed letting the technologist know that the stroke margin safety had been exceeded, and the needle went through the patient breast when fired. The technologist spoke with a clinical application specialist who reviewed multiple things with her to determine what could have caused the problem. All tests done showed the unit to be working properly. A field engineer evaluated the system and completed the quality control check alone and again with the technologist and no system malfunction was found. The plastic breast tray was replaced. Additional information received from the technologist noted that the patient had a small hematoma which resolved on its own and no medical intervention was needed. The biopsy was completed successfully and there have been other successful biopsies completed without issue since this event. She noted that the system had been "lagging" that day and the target had to be sent three times to be accepted. She was unsure if this issue was occurring with other systems that day or only this system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220984-2019-00007 |
| MDR Report Key | 8247810 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-01-15 |
| Date of Report | 2018-12-17 |
| Date of Event | 2018-12-17 |
| Date Mfgr Received | 2018-12-17 |
| Device Manufacturer Date | 2014-03-01 |
| Date Added to Maude | 2019-01-15 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KRISTIN FORNIERI |
| Manufacturer Street | 36 & 37 APPLE RIDGE ROAD |
| Manufacturer City | DANBURY CT 06810 |
| Manufacturer Country | US |
| Manufacturer Postal | 06810 |
| Manufacturer Phone | 2037318491 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTICARE PLATINUM |
| Generic Name | STEREOTACTIC BREAST BIOPSY SYSTEM |
| Product Code | IZH |
| Date Received | 2019-01-15 |
| Model Number | 8-004-0017 |
| Catalog Number | 8-004-0017 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 36 & 37 APPLE RIDGE ROAD DANBURY CT 06810 US 06810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-15 |