MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-11-29 for 3.5F BETA-RAIL DELIVERY CATHETER P02578 ABR-0346 manufactured by Novoste Corporation.
[596086]
After successful completion of the procedure, the radiation source train became stuck in the delivery catheter and would not return to the transfer device.
Patient Sequence No: 1, Text Type: D, B5
[8055050]
The evaluation of the returned system found the radioactive source train trapped in a kink in the catheter approximately 80cm from the distal tip of the delivery catheter. The source train would not move proximally or distally when fluid pressure was applied through the transfer device. There was no leakage from the closed system identified during the transport testing indicating hydraulic system integrity was maintained. The catheter was cut and the radioactive sourcetrain was removed. A visual examination of the source train was performed. The source train appeared to be in good condition. There were no deviations to specification identified that would have contributed to the source train not returning to the transfer device. The transfer device was tested and was found to meet all required specifications. The catheter was inspected, the kink in the delivery catheter 80cm from the distal tip was the only anomaly to the catheter identified. The probable root cause of the source train not returning to the transfer device is the kink in the delivery catheter.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1062385-2004-00008 |
| MDR Report Key | 803648 |
| Report Source | 05 |
| Date Received | 2004-11-29 |
| Date of Report | 2004-11-24 |
| Date of Event | 2004-09-23 |
| Date Mfgr Received | 2004-10-14 |
| Device Manufacturer Date | 2004-04-01 |
| Date Added to Maude | 2007-01-16 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DREW GREEN, VP |
| Manufacturer Street | 4350 INTERNATIONAL BLVD |
| Manufacturer City | NORCROSS GA 30093 |
| Manufacturer Country | US |
| Manufacturer Postal | 30093 |
| Manufacturer Phone | 7707176059 |
| Manufacturer G1 | NOVOSTE CORPORATION |
| Manufacturer Street | 4350 INTERNATIONAL BLVD |
| Manufacturer City | NORCROSS GA 30093 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30093 |
| 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 | 2004-11-29 |
| Returned To Mfg | 2004-10-18 |
| Model Number | P02578 |
| Catalog Number | ABR-0346 |
| Lot Number | 712650 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 791153 |
| Manufacturer | NOVOSTE CORPORATION |
| Manufacturer Address | 4350 INTERNATIONAL BLVD. NORCROSS GA 30093 US |
| Baseline Brand Name | 3.5F BETA-RAIL DELIVERY CATHETER |
| Baseline Generic Name | CATHETER |
| Baseline Model No | P02578 |
| Baseline Catalog No | ABR-0346 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-11-29 |