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 2003-08-22 for GALILEO INTRAVASCULAR RADIOTHERAPY CARTRIDGE, SOURCE WIRE 1008114-0C NA manufactured by Guidant Vascular Intervention.
[291448]
The site was performing a tandem treatment. The proximal reference lumen diameter (rld) was determined to be 3. 3 mm and the distal rld was determined to be 2. 8 mm. The proximal segment was treated successfully. The rld value for the distal segment was mistakenly entered as 3. 3 mm rather than 2. 8 mm as was measured. The site investigated the possible misadministration with the depth dose tables provided in the galileo instructions for use. The site calculated the dose delivered to be 26. 4gy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651662-2003-00010 |
| MDR Report Key | 483415 |
| Report Source | 05,06,07 |
| Date Received | 2003-08-22 |
| Date of Report | 2003-07-25 |
| Date of Event | 2002-06-20 |
| Date Mfgr Received | 2003-07-25 |
| Date Added to Maude | 2003-09-16 |
| 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 | 0 |
| Reporter Occupation | PHYSICIST |
| 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 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| 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 | 2003-08-22 |
| Returned To Mfg | 2002-07-12 |
| Model Number | 1008114-0C |
| 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 | 472311 |
| Manufacturer | GUIDANT VASCULAR INTERVENTION |
| Manufacturer Address | 26531 YNEZ ROAD TEMECULA CA 92591 US |
| Baseline Brand Name | GALILEO INTRAVASCULAR RADIOTHERAPY CARTRIDGE, SOURCE WIRE |
| Baseline Generic Name | RADIATION SYSTEM CARTRIDGE |
| Baseline Model No | 1008114-0C |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| 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 | 2003-08-22 |