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 2004-03-25 for GALILEO INTRAVASCULAR RADIOTHERAPY CARTRIDGE, SOURCE WIRE 1008112-0A NA manufactured by Guidant Vascular Intervention.
[335539]
A patient enrolled in the vision ii trial had a brachytherapy procedure procedure performed in 2003. The event stated that twenty minutes after the procedure, the right artery was open, but the apperance was "not clear, making the doctors think there was thrombus in site. " the patient was treated with a new angioplasty balloon and two additional stents. There were no complications and no enzyme elevations. Further, there was no "ds" or "mmi". The report also stated "didn't pay enough attention to the proximal part. Insufficient prep with ticlid. An allergy ti plavix. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651662-2004-00003 |
| MDR Report Key | 518176 |
| Report Source | 05,06,07 |
| Date Received | 2004-03-25 |
| Date of Report | 2003-03-04 |
| Date of Event | 2003-03-04 |
| Date Mfgr Received | 2003-03-04 |
| Device Manufacturer Date | 2000-08-01 |
| Date Added to Maude | 2004-03-31 |
| 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 | OT |
| 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 | 2004-03-25 |
| Model Number | 1008112-0A |
| 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 | 507214 |
| 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 | 1008112-0A |
| 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 | 2004-03-25 |