MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-23 for BETA-CATH 3.5F SYSTEM * manufactured by Best Vascular, Inc..
[21449720]
During the beta-cath procedure (vascular brachytherapy), the radioactive strontium-90 source was not retracted to the safe position due to the catheter kink at the end of the treatment. The whole treatment was done without any discrepancy between prescribed and delivered dose. The source was manually placed in the shielded container, and currently is in the shielded room (hot lab). The source is additionally shielded and it will be shipped to the vendor when we receive the proper shielding container from the vendor. The manufacturer is sending a representative to inspect the device and determine whether the sources may be safely retracted. These kinks are known within the field.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4384678 |
| MDR Report Key | 4384678 |
| Date Received | 2014-12-23 |
| Date of Report | 2014-12-23 |
| Date of Event | 2014-12-11 |
| Report Date | 2014-12-23 |
| Date Reported to FDA | 2014-12-23 |
| Date Reported to Mfgr | 2015-01-06 |
| Date Added to Maude | 2015-01-06 |
| 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 | BETA-CATH 3.5F SYSTEM |
| Generic Name | INTRAVASCULAR RADIATION DELIVERY SYSTEM |
| Product Code | MOU |
| Date Received | 2014-12-23 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 84025 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEST VASCULAR, INC. |
| Manufacturer Address | 4350 INTERNATIONAL BLVD NORCROSS GA 30093 US 30093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-23 |