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 2003-10-18 for GALILEO INTRAVASCULAR RADIOTHERAPY CARTRIDGE, SOURCE WIRE 1008112-0C NA manufactured by Guidant Vascular Intervention.
[302523]
A 52 mm centering catheter was incorrectly placed. The proximal catheter marker was mistaken for the distal catheter marker and was placed distal to the target lesion. This resulted in the treatment being performed approx 52 mm distal to the target lesion. The site reported that only a small distal portion of the lesion was treated. The decision was made to treat the pt at a later date. The pt is stable at this time. It should be noted that several subsequent follow up conversations with the site resulted in conflicting info related to the details of event. Additional info was received indicating that one of the catheter markers may have been missing, however, the catheter was reported to have been discarded at that time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651662-2003-00016 |
| MDR Report Key | 492203 |
| Report Source | 05,06,07 |
| Date Received | 2003-10-18 |
| Date of Report | 2003-09-19 |
| Date of Event | 2003-09-17 |
| Date Mfgr Received | 2003-09-19 |
| Device Manufacturer Date | 2001-08-01 |
| Date Added to Maude | 2003-10-30 |
| 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 | 0 |
| 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 | 2003-10-18 |
| Returned To Mfg | 2003-10-09 |
| Model Number | 1008112-0C |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 480903 |
| Manufacturer | GUIDANT VASCULAR INTERVENTION |
| Manufacturer Address | 26531 YNEZ ROAD TEMECULA CA 92951 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. Other | 2003-10-18 |