MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-20 for SAVI-08 REF # SAVI-08 PMM ITEM # 39941 manufactured by Cianna Medical.
[95620552]
Savi catheter inserted (b)(6) 2017. On (b)(6) 2017 failed explant of savi device removal from breast. The coupling disengaged between the central catheter and the device, so the device could not be deflated. Pt had to return to the operating room for removal on (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074154 |
| MDR Report Key | 7138499 |
| Date Received | 2017-12-20 |
| Date of Report | 2017-12-13 |
| Date of Event | 2017-12-08 |
| Date Added to Maude | 2017-12-21 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | RISK MANAGER |
| 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 | SAVI-08 |
| Generic Name | SAVI BRACHYTHERAPY CATHETER |
| Product Code | JAQ |
| Date Received | 2017-12-20 |
| Model Number | REF # SAVI-08 |
| Catalog Number | PMM ITEM # 39941 |
| Lot Number | ML03044 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CIANNA MEDICAL |
| Manufacturer Address | ALISO VIEJO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-20 |