MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-03-13 for SAVI APPLICATOR SAVI-08 manufactured by Clanna Medical.
[18182598]
A company representative received an e-mail from a customer stating that at a six month followup visit subsequent to lumpectomy and apbi treatment using the savi device, the mammogram image showed an artifact that appeared to be a foreign body. The shape of the artifact resembled the shape of the savi tip. Subsequent ultrasound evaluation confirmed that the mammogram image was a foreign body. On (b)(6), 2012, a procedure was performed to retrieve the foreign body.
Patient Sequence No: 1, Text Type: D, B5
[18519730]
The foreign body retrieved during the (b)(6) 2012 procedure was received by the company on (b)(4) 2012. It was confirmed visually that the component was the tip of the savi device. Engineering evaluation concluded that a manufacturing glue process was inadequate or incomplete resulting in the improper attachment of the tip.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032338-2012-00001 |
| MDR Report Key | 2513648 |
| Report Source | 06,07 |
| Date Received | 2012-03-13 |
| Date of Report | 2012-02-13 |
| Date of Event | 2012-01-20 |
| Device Manufacturer Date | 2011-06-16 |
| Date Added to Maude | 2012-08-29 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 6 JOURNEY SUITE 125 |
| Manufacturer City | ALISO VIEJO CA 92656 |
| Manufacturer Country | US |
| Manufacturer Postal | 92656 |
| Manufacturer Phone | 9493600059 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAVI APPLICATOR |
| Generic Name | RADIO-NUCLIDE APPLICATOR |
| Product Code | MIJ |
| Date Received | 2012-03-13 |
| Model Number | SAVI-08 |
| Lot Number | ML00789 |
| Device Expiration Date | 2013-06-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLANNA MEDICAL |
| Manufacturer Address | ALISO VIEJO CA 92656 US 92656 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-03-13 |