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 2003-06-19 for GALILEO INTRAVASCULAR RADIOTHERAPY CARTRIDGE, SOURCE WIRE 1008112-0C NA manufactured by Guidant Vascular Intervention.
[327593]
The guidant clinical consultant reported that a product malfunction occurred during treatment of the third of 3 pts. The previous 2 treatments were successful. The treatment of the third pt began with successful positioning of the inactive wire. The active wire was deployed and then stopped, and the ruler on the display screen indicated it to be near the target position. It was noted that the yellow radiation light on the top of the sdu continued to flash (indicating wire in transit). A fluoro view to check the position of the wire found no source in the field of view. A malfunction was suspected and emergency procedures were initiated. The pt was surveyed confirming that the source stopped inside the pt. Attempts to retract the wire using the "interrupt treatment" button on the display screen, the red "stop" button on the unit, catheter key ejection, and the manual retract wheel were unsuccessful. The radiation oncologist used tongs to remove the catheter and active wire from the pt. The unit was unplugged, thus engaging the battery powered emergency retract motor, and the active wire retracted. The physicist stated that the active wire dwelled in the pt for approx 60-90 seconds. After the case, the site extended and retracted both wires and the system functioned properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651662-2003-00006 |
| MDR Report Key | 468961 |
| Report Source | 05,06,07 |
| Date Received | 2003-06-19 |
| Date of Report | 2003-05-22 |
| Date of Event | 2003-05-22 |
| Date Mfgr Received | 2003-05-22 |
| Device Manufacturer Date | 2001-07-01 |
| Date Added to Maude | 2003-07-02 |
| 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 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| Manufacturer Phone | 9099142050 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | 2003-06-19 |
| Returned To Mfg | 2003-05-28 |
| 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 | 457861 |
| 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 | 2003-06-19 |