MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2003-06-20 for 3.5F BETA-RAIL DELIVERY CATHETER P00563 ABR-0340 manufactured by Novoste Corp..
[326626]
The source train movement was restricted approximately 30mm from the end of the catheter. The source train could not be returned to the transfer device, so the user removed the entire system from the patient. User reported this incident as a misadministration to the state bureau of environment and radiation protection per licensing requirements. Patient was not injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1062385-2003-00010 |
| MDR Report Key | 467698 |
| Report Source | 05,07 |
| Date Received | 2003-06-20 |
| Date of Report | 2003-06-16 |
| Date of Event | 2003-05-22 |
| Date Mfgr Received | 2003-06-12 |
| Device Manufacturer Date | 2003-04-01 |
| Date Added to Maude | 2003-06-26 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ADAM LOWE, VP |
| Manufacturer Street | 3890 STEVE REYNOLDS BLVD |
| Manufacturer City | NORCROSS GA 30093 |
| Manufacturer Country | US |
| Manufacturer Postal | 30093 |
| Manufacturer Phone | 7707170904 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3.5F BETA-RAIL DELIVERY CATHETER |
| Generic Name | CATHETER |
| Product Code | MOU |
| Date Received | 2003-06-20 |
| Returned To Mfg | 2003-06-06 |
| Model Number | P00563 |
| Catalog Number | ABR-0340 |
| Lot Number | 647619 |
| ID Number | NA |
| Device Expiration Date | 2005-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 456623 |
| Manufacturer | NOVOSTE CORP. |
| Manufacturer Address | 3890 STEVE REYNOLDS BLVD. NORCROSS GA 30093 US |
| Baseline Brand Name | BETA-RAIL 35F DELIVERY CATHETER |
| Baseline Generic Name | CATHETER |
| Baseline Model No | P00563 |
| Baseline Catalog No | ABR-0340 |
| Baseline ID | NA |
| Baseline Device Family | BETA-RAIL 3.5F DELIVERY CATHETER |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | Y |
| Premarket Approval | P0000 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-06-20 |