MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-03-19 for GALILEO INTRAVASCULAR RADIOTHERAPY CARTRIDGE, SOURCE WIRE 1008112-0C NA manufactured by Guidant Vascular Intervention.
[28387109]
Method: the event log for this device was evaluated not the device itself. (b)(4). During processing of this complaint, quality assurance attempted to obtain complete event information and patient status from the hospital, field contact or distributor. Evaluation summary: dr. Williams faxed a drawing demonstrating the particular treatment he had questions about. The summary of his three questions were what dose was given in the overlapped region using a rld of 3. 2 mm (using a 3. 0 mm catheter), what dose was given in the 5 mm transitional segment shown in the drawing and what dose was given to segment c as shown in the drawing. In working with guidant consultant physicist, they resolved that the dose given in the overlapped region was 280 cgy. The dose in the 5 mm transitional segment starts at 2080 cgy and drops very quickly to 1364 cgy. Lastly, the dose for segment c was determined to be 1364 cgy. Subsequently, the site physicist, (b)(6), contacted another guidance consultant about this case. The physicist recreated the treatment and filmed it. The results of this recreation resulted in a different dose calculation estimate from the original calculations. A guidance radiation safety officer (rso) and consultant physicist consulted with the site to reconcile the calculations. It was determined through additional recreation and the usage of the returned cartridge event log data that the dose in the overlap region was about 2700-2800 cgy. The dose in the non-overlap region was about 2000 cgy distally and about 1500 cgy proximally. Previous estimated had calculated 2000 and 1364 cgy respectively. Guidant contacted the site and both the radiation oncologist and the physicist do not believe that the above doses were injurious to the patient. The event log data was reviewed for this treatment and the rso calculated the dose delivered in the overlap region as 2775 cgy. The dose in the non-overlap region was 2000 cgy delivered distally and 1364 cgy delivered proximally. The delivered doses outside the prescribed range were due to the user performing a complete treatment in addition to a partial treatment for the same patient in the same lesion, which resulted in an overlap. The site was informed of the dosage calculations based on the event log data. An ifu addendum has been released that contains a warning statement to reinforce the importance of properly resuming a treatment, as specified in the ifu, and to warn users of the potential consequences of radiation overdose.
Patient Sequence No: 1, Text Type: N, H10
[28387110]
The radiologist oncologist requested to speak with a physicist to answer questions concerning overlap during a treatment performed this morning (2003). The treatment consisted of the following: a two-position treatment was performed, in which the second position was interrupted by the radiation oncologist, then the radiation oncologist repositioned the catheter and initiated a new two-position treatment with the first position overlapping with the second position of the first treatment. This second treatment was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651662-2004-00006 |
| MDR Report Key | 5137555 |
| Date Received | 2004-03-19 |
| Date of Report | 2004-02-19 |
| Date of Event | 2003-10-20 |
| Date Mfgr Received | 2004-02-19 |
| Device Manufacturer Date | 2001-03-01 |
| Date Added to Maude | 2015-10-08 |
| 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 | TEMCULA CA 92591 |
| Manufacturer Country | US |
| Manufacturer Postal | 92591 |
| Manufacturer Phone | 9099142050 |
| Manufacturer G1 | GUIDANT CORP. |
| Manufacturer Street | 8934 KIRBY DR. |
| Manufacturer City | HOUSTON TX 77054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GALILEO INTRAVASCULAR RADIOTHERAPY CARTRIDGE, SOURCE WIRE |
| Generic Name | RADIATION SYSTEM CARTRIDGE |
| Product Code | MOU |
| Date Received | 2004-03-19 |
| Returned To Mfg | 2003-11-04 |
| Model Number | 1008112-0C |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GUIDANT VASCULAR INTERVENTION |
| Manufacturer Address | 26531 YNEZ ROAD TEMECULA CA 92591 US 92591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-03-19 |