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

Model Number	85900PST
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	04/06/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Patient information: no information available.Test dates and medical history: no information available.Suspect products: not applicable for this device.Implant, explant, and device evaluation dates: not applicable for this device.The eagle eye platinum st device was infectious; therefore, returned product investigation was not performed.(b)(4).Remedial action & removal #: do not apply to this submission.
Event or Problem Description
It was reported that during a coronary procedure while advancing to the lesion, the manufacturer's catheter could not cross the lesion and lost image.At some point after the manufacturer's catheter was removed from the patient, a perforation occurred caused by a wire from a different manufacturer, resulting in patient death later that evening.The physician stated that the manufacturer's catheter had nothing to do with the perforation in the artery.There was no damage observed on the manufacturer's device after removal from the patient.This adverse event is being submitted because the manufacturer¿s device is a concomitant device in a procedure where a patient death from another manufacture¿s device occurred.
Additional Manufacturer Narrative
Internal reference: (b)(4).Block h6: added codes 416 (display) and 1802 (death).

• Brand Name: EAGLE EYE PLATINUM ST
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 11778675
• Report Number: 2939520-2021-00025
• Device Sequence Number: 3946418
• Product Code: OBJ
• UDI-Device Identifier: 00845225002312
• UDI-Public: (01)00845225002312(17)220731(10)0301983146(90)989609000481
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K143701
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 85900PST
• Device Catalogue Number: 400-0200.141
• Device Lot Number: 0301983146
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 06/06/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK MFG AND SIZE: GUIDE CATHETER.; UNK MFG AND SIZE: GUIDE WIRE.; UNK MFG AND SIZE: INTRODUCER SHEATH.; UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Death