MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-10-07 for 5F BETA-RAIL DELIVERY CATHETER P02578 ABR-0346 manufactured by Novoste Corp.
[683522]
The site reported that during treatment of in-stent restenosis of the distal anterior descending coronary artery, after the area was treated with multiple angioplasties with a 3. 0mm balloon, a 60mm radioactive source train was selected. After sending source train, it was recognized that the source train was not long enough to treat the entire injury area. The catheter was pulled back in order to treat the second segment. The source train was sent again, there was some difficulty getting the source train to the distal tip of the catheter, but the source train did reach the distal tip. The proximal segment was treated. After treatment was completed, films were reviewed to determine why the radioactive source train was not long enough to treat the entire injury area. It was determined that upon initial delivery of the radioactive source train, the source train stopped short of the distal end of the delivery catheter by 25 - 30mm. The proximal marker was not clearly visible because it ran posteriorly behind the guide catheter and other radioactive seeds. The distal marker was recognized as the proximal marker because of where it was in relationship to the distal tip of the catheter, thus the distal segment of the catheter never rec'd the prescribed radiation. Because the source train never reached the distal endo f the catheter on the first dwell, and a second dwell was used to treat the proximal segment, a 35-40mm segment rec'd twice the prescribed amount of radiation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1062385-2004-00006 |
| MDR Report Key | 906744 |
| Report Source | 07 |
| Date Received | 2004-10-07 |
| Date of Report | 2004-10-06 |
| Date of Event | 2004-09-17 |
| Date Mfgr Received | 2004-09-20 |
| Date Added to Maude | 2007-09-05 |
| 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 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5F BETA-RAIL DELIVERY CATHETER |
| Generic Name | CATHETER |
| Product Code | MOU |
| Date Received | 2004-10-07 |
| Model Number | P02578 |
| Catalog Number | ABR-0346 |
| Lot Number | 737827 |
| ID Number | NA |
| Device Expiration Date | 2006-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 881259 |
| Manufacturer | NOVOSTE CORP |
| Manufacturer Address | 4350 INTERNATIONAL BLVD. NORCROSS GA 30093 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-10-07 |