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 1008112-0C NA manufactured by Guidant Vascular Intervention.
[330692]
Guidant became aware of the following event: "... Using a three-step automated system, as the first step was completed, the authorized user intervened and repositioned the system markers to intentionally deliver an additional dose to a portion of the lesion being treated. The calculated delivered dose was 24. 6 gray, 23 percent greater than the original treatment prescription of 20 gray... " guidant followed up with the site after becoming aware of this event. It was reported that the site started to treat the patient for approximately 40 seconds at the first treatment position before deciding to interrupt the treatment and reposition the catheter to better cover the lesion. During this time, the decision was made to also reduce the rld from 3. 2 to 3. 0. User then performed a full treatment in the new catheter position, which resulted in one segment receiving an extra 40 seconds of dose.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651662-2003-00014 |
| MDR Report Key | 483587 |
| Report Source | 05,06,07 |
| Date Received | 2003-08-22 |
| Date of Report | 2002-12-05 |
| Date of Event | 2002-12-05 |
| Date Mfgr Received | 2002-12-05 |
| Device Manufacturer Date | 2001-01-01 |
| Date Added to Maude | 2003-09-17 |
| 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 | RB |
| 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 | 2003-01-16 |
| 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 | 472473 |
| 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 | 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 | 2003-08-22 |