MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-09-07 for PIONEER PLUS CATHETER PPLUS120 400-0200.246 manufactured by Philips Volcano.
| Report Number | 2939520-2019-00051 |
| MDR Report Key | 8972998 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-09-07 |
| Date of Report | 2019-08-12 |
| Date of Event | 2019-08-08 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-09-18 |
| Device Manufacturer Date | 2019-06-27 |
| Date Added to Maude | 2019-09-07 |
| 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 | 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 | LAKE REGION MEDICAL |
| Manufacturer Street | 45 LEXINGTON DRIVE |
| Manufacturer City | LACONIA NH 03246 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03246 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PIONEER PLUS CATHETER |
| Generic Name | CATHETER FOR CROSSING TOTAL OCCULUSIONS |
| Product Code | PDU |
| Date Received | 2019-09-07 |
| Returned To Mfg | 2019-09-18 |
| Model Number | PPLUS120 |
| Catalog Number | 400-0200.246 |
| Lot Number | 4646327 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS VOLCANO |
| Manufacturer Address | 2870 KILGORE ROAD RANCHO CORDOVA CA 95670 US 95670 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-09-07 |