MAUDE Adverse Event Report: PHILIPS VOLCANO EAGLE EYE PLATINUM CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	85900P
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference: (b)(4).Facility declined to provide patient information of id, gender, age, and weight.No information available.The implant or explant dates are not applicable to this device.Concomitant medical products: no information available.The device was discarded on site and will not be returned to the manufacturer.
Event or Problem Description
This case was reviewed and investigated according to the manufacturer's policy.It was reported that a device labeled as "demo" [demonstration] and "not for human use" was used during a patient procedure.The product performed as intended and no injuries were reported.Additional information received stated the patient is doing very well; no complications.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.This product problem is being submitted because the sterility of the device, at the time of use, cannot be confirmed by the manufacturer.

• Brand Name: EAGLE EYE PLATINUM CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 8844408
• Report Number: 2939520-2019-00046
• Device Sequence Number: 242846
• Product Code: OBJ
• UDI-Device Identifier: 00845225001278
• UDI-Public: (01)00845225001278(17)200731(10)0301478184(90)989609002381
• Combination Product (Y/N): Y
• Initial Reporter Country: BE
• PMA/510(K) Number: K143701
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2019
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: 85900P
• Device Catalogue Number: 809746001
• Device Lot Number: 0301478184
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005