MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-28 for SENORX ENCORE MRI TROCAR TIP PROBE ECPMR0110G manufactured by Bard Peripheral Vascular Inc.
[34403506]
Patient Sequence No: 1, Text Type: N, H10
[34403507]
Mri breast biopsy. During the second sweep of breast sample, the biopsy needle was felt to have been resistant to attending physician. When biopsy device was removed, the end was not attached to biopsy trocar gun. Dr could see the tip and removed the end piece from the patient's breast with no injury to the patient. Remaining stock of introducers were removed from shelves and will call area manager to replace remaining stock.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5328882 |
| MDR Report Key | 5328882 |
| Date Received | 2015-12-28 |
| Date of Report | 2015-11-23 |
| Date of Event | 2015-11-19 |
| Report Date | 2015-11-23 |
| Date Reported to FDA | 2015-11-23 |
| Date Reported to Mfgr | 2015-11-23 |
| Date Added to Maude | 2015-12-28 |
| 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 | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 | 3 |
| Brand Name | SENORX ENCORE MRI TROCAR TIP PROBE |
| Generic Name | INSTRUMENT, BIOPSY, SUCTION |
| Product Code | FCK |
| Date Received | 2015-12-28 |
| Catalog Number | ECPMR0110G |
| Lot Number | VT15B0076 |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR INC |
| Manufacturer Address | 1415 WEST 3RD ST. SUITE 109 TEMPE AZ 85280 US 85280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-28 |