MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2004-03-26 for GALILEO INTRAVASCULAR RADIOTHERAPY CARTRIDGE, SOURCE WIRE 1008112-0C NA manufactured by Guidant Vascular Intervention.
[334751]
A guidant clinical account coordinator (cac) reported that a pt that was treated with radiation (using the galileo system) in september 2003 presented in 2004 with an aneurysm of the left ventricle. The pt was treated for this condition, although the exact treatment was not reported. It could not be determined if the radiation treatment performed in september, 2003 could be related to the pt's current condition. Guidant followed up for additional details of the event and the pt status. It was reported that the radiation treatment was delivered to the circumflex artery in 2003 prior to the radiation treatment, the pt had only had an echocardiogram to assess the left ventricle. After radiation treatment, an lv gram was performed and that is when the cardiologist noted the aneurysm in the lateral wall of the left ventricle. The cardiologist felt like the radiation treatment could have contributed to the aneurysm since the circumflex artery feeds the lateral wall of the ventricle, however since an lv gram was not done prior to the radiation treatment, it is unk if the pt might have had the aneurysm at that time. The pt's current condition is stable and the cardiologist has not determined what further treatment may be necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651662-2004-00002 |
| MDR Report Key | 517937 |
| Report Source | 05,06,07 |
| Date Received | 2004-03-26 |
| Date of Report | 2004-02-26 |
| Date of Event | 2004-02-26 |
| Date Mfgr Received | 2004-02-26 |
| Device Manufacturer Date | 2000-09-01 |
| Date Added to Maude | 2004-03-30 |
| 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 | 3 |
| Manufacturer Contact | DENISE VINMANS |
| Manufacturer Street | 26531 YNEZ ROAD |
| Manufacturer City | TEMECULA CA 92591 |
| Manufacturer Country | US |
| Manufacturer Postal | 92591 |
| Manufacturer Phone | 9099142050 |
| Manufacturer G1 | GUIDANT, HOUSTON |
| Manufacturer Street | 8934 KIRBY DRIVE |
| Manufacturer City | HOUSTON TX 77054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77054 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GALILEO INTRAVASCULAR RADIOTHERAPY CARTRIDGE, SOURCE WIRE |
| Generic Name | RADIATION SYSTEM CARTRIDGE |
| Product Code | MOU |
| Date Received | 2004-03-26 |
| Model Number | 1008112-0C |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 506972 |
| Manufacturer | GUIDANT VASCULAR INTERVENTION |
| Manufacturer Address | 26531 YNEZ RD TEMECULA CA 92591 US |
| Baseline Brand Name | GALILEO INTRAVASCULAR RADIOTHERAPY CARTRIDGE, SOURCE WIRE |
| Baseline Generic Name | RADIATION SYSTEM CARTRIDGE |
| Baseline Model No | 1008112-0C |
| Baseline Device Family | RADIATION SYSTEM CARTRIDGE |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | Y |
| Premarket Approval | P0000 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2004-03-26 |