MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-07-17 for NOVOSTE M097ABR03400 ABR-0340 manufactured by Novoste Corp.
[269050]
After completion if brachytherapy procedure, tip of catheter found off the catheter and snagged on the guide wire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 405970 |
| MDR Report Key | 405970 |
| Date Received | 2002-07-17 |
| Date of Report | 2002-07-17 |
| Date of Event | 2002-07-16 |
| Date Facility Aware | 2002-07-16 |
| Report Date | 2002-07-17 |
| Date Reported to FDA | 2002-07-17 |
| Date Reported to Mfgr | 2002-07-17 |
| Date Added to Maude | 2002-07-23 |
| 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 |
| 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 |
| Generic Name | B-RAIL 3.5 F DELIVERY CATHETER |
| Product Code | MOV |
| Date Received | 2002-07-17 |
| Model Number | M097ABR03400 |
| Catalog Number | ABR-0340 |
| Lot Number | 523837 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 394959 |
| Manufacturer | NOVOSTE CORP |
| Manufacturer Address | 3890 STEVE REYNOLDS BLVD NORCROSS GA 30093 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-07-17 |