MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-09 for DELIVERY CATHETER * manufactured by Novoste Corp.
[353124]
Pt having right renal artery brachytherapy done. During seed extraction, seeds got stuck in delivery catheter. Catheter secured in lead box. No risk or harm to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 554381 |
| MDR Report Key | 554381 |
| Date Received | 2004-11-09 |
| Date of Report | 2004-11-05 |
| Date of Event | 2004-11-05 |
| Date Facility Aware | 2004-11-05 |
| Report Date | 2004-11-05 |
| Date Reported to FDA | 2004-11-05 |
| Date Reported to Mfgr | 2004-11-05 |
| Date Added to Maude | 2004-11-15 |
| 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 | 3 |
| 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 | DELIVERY CATHETER |
| Generic Name | 3.5 DELIVERY CATHETER & PROCEDURE ACCESSORY KIT |
| Product Code | MOU |
| Date Received | 2004-11-09 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 712654 |
| ID Number | REF ABR-0346 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 544009 |
| Manufacturer | NOVOSTE CORP |
| Manufacturer Address | 3890 STEVE REYNOLDS BLVD. NORCROSS GA 30093 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-11-09 |