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 2003-09-29 for GALILEO INTRAVASCULAR RADIOTHERAPY CARTRIDGE, SOURCE WIRE 1008112-0C NA manufactured by Guidant Vascular Intervention.
[18913235]
A patient underwent successful brachytherapy treatment in 2003 and returned symptomatic three months later. It was determined upon catheterization that the patient had a 3. 5mm - 4mm long pseudoaneurysm formation in the proximal right coronary artery just distal to the stent. It was reported that during the original brachytherapy procedure, there may have been a dissection and some thrombus was observed distal to the stent after the centering catheter was placed, however, post dilatation of the area showed a nice result. The pseudoaneurysm was treated using a balloon catheter and the result was good. Guidant followed up as to patient status. The patient is reported to be clinically stable with no recurrent angina, and no further work up or change in medications is warranted. The patient will be monitored.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651662-2003-00015 |
| MDR Report Key | 487017 |
| Report Source | 05,06,07 |
| Date Received | 2003-09-29 |
| Date of Report | 2003-08-28 |
| Date of Event | 2003-08-26 |
| Date Mfgr Received | 2003-08-28 |
| Device Manufacturer Date | 2001-05-01 |
| Date Added to Maude | 2003-10-07 |
| 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 | 2003-09-29 |
| Model Number | 1008112-0C |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 475905 |
| Manufacturer | GUIDANT VASCULAR INTERVENTION |
| Manufacturer Address | 23651 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 | 1. Life Threatening | 2003-09-29 |