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 2020-02-06 for EAGLE EYE PLATINUM CATHETER 85900P 809746001 manufactured by Philips Volcano.
[178319438]
Internal reference: (b)(4). Patient identifier, age or date of birth, sex , weight, ethnicity, race: attempts to obtain patient information have been unsuccessful. Device serial number and lot number have not been provided by the customer thus expiration date and udi are unknown. The implant or explant dates are not applicable to this device. Not applicable for this device. Item number: device was discarded at the customer site and not returned to manufacturer for analysis. Device was discarded at the customer site and not returned to manufacturer for analysis. Device serial and lot number have not been provided by the customer thus manufacture date is unknown. Do not apply to this submission. Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to the alleged death or deterioration in the state of the health of any person.
Patient Sequence No: 1, Text Type: N, H10
[178319439]
This case was reviewed and investigated according to the manufacturer? S policy. It was reported the manufacturers device may have caused or contributed to a vessel dissection. This adverse event is being submitted because the manufacture? S device was used in a procedure where the patient experienced a vessel dissection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939520-2020-00003 |
| MDR Report Key | 9677009 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-06 |
| Date of Report | 2020-01-29 |
| Date of Event | 2020-01-28 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-01-29 |
| Date Added to Maude | 2020-02-06 |
| 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 G1 | VOLCARICA S.R.L. |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EAGLE EYE PLATINUM CATHETER |
| Generic Name | CATHETER, ULTRASOUND, INTRAVASCULAR |
| Product Code | OBJ |
| Date Received | 2020-02-06 |
| Model Number | 85900P |
| Catalog Number | 809746001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS VOLCANO |
| Manufacturer Address | 2870 KILGORE ROAD RANCHO CORDOVA CA 95670 US 95670 |
| Product Code | --- |
| Date Received | 2020-02-06 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-06 |