MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-29 for PHOENIX CATH SYSTEM, 2.4MM X 127CM, 7F (KIT) PD24127K 400-0200.294 manufactured by Philips Volcano Atheromed.
| Report Number | 2939520-2020-00008 |
| MDR Report Key | 9772560 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-29 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-02-12 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-02-29 |
| 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 | MS. MELISSA MANGUM |
| Manufacturer Street | 2870 KILGORE ROAD |
| Manufacturer City | RANCHO CORDOVA CA 95670 |
| Manufacturer Country | US |
| Manufacturer Postal | 95670 |
| Manufacturer Phone | 8584650468 |
| Manufacturer G1 | VOLCANO ATHEROMED, INC. |
| Manufacturer Street | 1530 O BRIEN DRIVE, SUITE A |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94025 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHOENIX CATH SYSTEM, 2.4MM X 127CM, 7F (KIT) |
| Generic Name | CATHETER, PERIPHERAL, ATHERECTOMY |
| Product Code | MCW |
| Date Received | 2020-02-29 |
| Model Number | PD24127K |
| Catalog Number | 400-0200.294 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS VOLCANO ATHEROMED |
| Manufacturer Address | 2870 KILGORE ROAD RANCHO CORDOVA CA 95670 US 95670 |
| Product Code | --- |
| Date Received | 2020-02-29 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-29 |