MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2008-09-04 for SAVI APPLICATOR RTK-08 * manufactured by Cianna Medical.
[17766136]
Subsequent to placement of the savi device, ct imaging revealed an inverted or splayed strut. Further expansion of the device was performed and add'l ct imaging showed that 4 struts were expanded normally and that 4 struts were splayed. The decision was made to remove the device. The device was collapsed and the device was removed, however, upon removal, it was observed that the device was not completely collapsed, causing discomfort to the pt. The incision site was closed with no sequelae. Pt was subsequently referred for other radiation therapies.
Patient Sequence No: 1, Text Type: D, B5
[17982195]
Upon receipt of the device, an engineering eval was conducted and the following was observed: macroscopic eval: the catheter #6 strut assembly was inverted. The remaining catheters were in the expanded position in a symmetrical pattern. The distal shaft of the applicator showed a slight bend. The expansion tool was seated against the make/hexagonal formed feature at the proximal end of the actuating screw and rotated counter clockwise. The struts collapsed without obstructions until the hard stop in the lead screw mechanism was reached indicating the fully collapsed position of the applicator struts. Subsequently, the expansion tool was rotated clockwise to expand the struts to the maximum expanded diameter. Again, the applicator expanded smoothly until the audible click was reached. Catheter #6 remained in its inverted position. The applicator was then decontaminated and catheter #6 was readjusted into a straight position and the applicator cycled 3 add'l times without encountering any obstructions. Conclusion: the lead screw mechanism that serves to expand and collapse the applicator worked appropriately. The actuation was smooth and the position indicators (hard stop and click) functioned as designed. Splayed struts can occur when the lumpectomy cavity is fibrotic and is attributable to cavity age and size. It is possible that the expansion tool was not properly engaged during the collapsing of the device. There was no observed device malfunction and no further reporting was indicated. This info is being provided based on add'l info rec'd via user facility report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032338-2008-00001 |
| MDR Report Key | 1250203 |
| Report Source | 06,07 |
| Date Received | 2008-09-04 |
| Date of Report | 2008-08-12 |
| Date of Event | 2008-06-11 |
| Date Mfgr Received | 2008-08-11 |
| Date Added to Maude | 2008-12-04 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Street | 6 JOURNEY STE. 125 |
| Manufacturer City | ALISO VIEJO CA 92656 |
| Manufacturer Country | US |
| Manufacturer Postal | 92656 |
| Manufacturer Phone | 9493600059 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| 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 | 2008-09-04 |
| Returned To Mfg | 2008-06-20 |
| Model Number | RTK-08 |
| Catalog Number | * |
| Lot Number | NOT KNOWN |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 1303548 |
| Manufacturer | CIANNA MEDICAL |
| Manufacturer Address | * ALISO VIEJO CA 92656 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-09-04 |