MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-05-05 for NOVOSTE BETACATH SYSTEM * manufactured by Best Vascular, Inc..
[1140916]
Novoste betacath system: the icrt catheter was kinked so the sr-90 radioactive train could not be sent back to the device. After the treatment was finished, md tied to push the sr-90 radioactive source back to the device, the sourceleft the treatment area and was stuck in the catheter junction outside of the patient's body. Md said the catheter had a kink at the junction. The catheter was pulled out from the patient's body and dumped in a shielded transportation box with whole device. The patient and room was surveyed using radiation survey meter. No radiation was found inside the patient body and in the treatment room of the cardiac cath lab.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1381021 |
| MDR Report Key | 1381021 |
| Date Received | 2009-05-05 |
| Date of Report | 2009-05-05 |
| Date of Event | 2009-04-28 |
| Report Date | 2009-05-05 |
| Date Reported to FDA | 2009-05-05 |
| Date Added to Maude | 2009-05-15 |
| 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 | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVOSTE BETACATH SYSTEM |
| Generic Name | CATHETER, BRACHYTHERAPY, INTRACAVITY, ICRT |
| Product Code | IWJ |
| Date Received | 2009-05-05 |
| Returned To Mfg | 2009-05-04 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | BETA-CATH 3.5R SYSTEM |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEST VASCULAR, INC. |
| Manufacturer Address | P.O. BOX 315 SPRINGFIELD VA 22150 US 22150 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-05-05 |