MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-19 for SAVI APPLICATOR manufactured by Cianna Medical.
[4355983]
Patient was scheduled for her last radiation treatment using the savi applicator. Applicator had been surgically placed in the pt on (b)(6) 2014. Pt was then scheduled to receive 10 treatments, twice a day. Her last treatment was (b)(6) 2014 and following the treatment the savi applicator was to be removed. The physician tried for 30 minutes to remove the savi applicator. It was presumed that scar tissue was adhering to the lumens of the catheter. The (b)(4) rep was present and tried to pull the catheter out and it broke apart. Pt was sent to surgeon's office the next day (b)(6) 2014 and another (b)(4) rep was present. The surgeon injected lidocaine into the cavity and used a hemostat to easily remove it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034674 |
| MDR Report Key | 3645470 |
| Date Received | 2014-02-19 |
| Date of Report | 2014-02-19 |
| Date of Event | 2014-02-03 |
| Date Added to Maude | 2014-02-26 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | SAVI APPLICATOR |
| Product Code | JAQ |
| Date Received | 2014-02-19 |
| Returned To Mfg | 2014-02-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CIANNA MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-02-19 |