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 2004-04-16 for GALILEO CENTERING CATHETER III 1009492 manufactured by Guidant Vascular Intervention.
[309762]
A centering catheter was used for a brachytherapy procedure in the proximal lad. The pt presented to the cath lab with multiple co-morbidities and did not tolerate any part of the procedure well. Predilatation of the lesion was performed, as well as an attempt to treat the lesion with another centering catheter. Positioning and delivery of therapy was performed without complications with the catheter and the device removed. Another lesion was identified 5-10 mm proximal to the treatment site at the lad takeoff from the left main. It was treated with a balloon and a stent. The circumflex artery then acutely shut down. Multiple attempts were made to reopen the vessel without success and the pt died. The physician believed the centering catheter played a part in the closure of the vessel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2004-00170 |
| MDR Report Key | 521066 |
| Report Source | 05,06,07 |
| Date Received | 2004-04-16 |
| Date of Report | 2004-03-17 |
| Date of Event | 2004-03-17 |
| Date Mfgr Received | 2004-03-17 |
| Device Manufacturer Date | 2003-09-01 |
| Date Added to Maude | 2004-04-20 |
| 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 RD |
| 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 | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GALILEO CENTERING CATHETER III |
| Generic Name | CORONARY CENTERING CATHETER |
| Product Code | MOU |
| Date Received | 2004-04-16 |
| Model Number | NA |
| Catalog Number | 1009492 |
| Lot Number | 3090352 |
| ID Number | NA |
| Device Expiration Date | 2005-08-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 510174 |
| Manufacturer | GUIDANT VASCULAR INTERVENTION |
| Manufacturer Address | 26531 YNEZ RD. TEMECULA CA 925914628 US |
| Baseline Brand Name | GALILEO CENTERING CATHETER III |
| Baseline Generic Name | CORONARY CENTERING CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | 1009492 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Required No Informationntervention | 2004-04-16 |