MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2003-09-18 for 3.5F BETA-RAIL DELIVERY CATHETER UNK manufactured by Novoste Corp..
[15187908]
It took approximately 1 minute after the 4:09 dwell treatment time to remove the delivery catheter and the radioactive source train from the patient to the bailout box. Patient condition is currenlty stable. The complainant reported the event to the state as a misadministration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1062385-2003-00011 |
| MDR Report Key | 485187 |
| Report Source | 05,07 |
| Date Received | 2003-09-18 |
| Date of Report | 2003-09-18 |
| Date of Event | 2003-08-18 |
| Date Mfgr Received | 2003-08-21 |
| Date Added to Maude | 2003-09-29 |
| 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 | 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 | 2003-09-18 |
| Returned To Mfg | 2003-09-09 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| 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 | 474074 |
| Manufacturer | NOVOSTE CORP. |
| Manufacturer Address | 3890 STEVE REYNOLDS BLVD. NORCROSS GA 30093 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-09-18 |