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

Model Number	85900PST
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Attempts to obtain patient information have been unsuccessful.Not applicable for this device.The implant or explant dates are not applicable to this device.Not applicable for this device.No information available.Country is (b)(6).Do not apply to this submission.Device evaluation anticipated, but not yet begun.
Event or Problem Description
Pci was performed to lad, using 2x drug eluting stents, involving the diagonal branch.Lad lesion was pre-dilated using a balloon and the ivus performed in lad and diagonal branch using eagle eye with no apparent problems.Stents were put in using proximal optimizing technique (pot), culotte and kbd (kissing balloon dilatation) technique.An eagle eye was used to ivus the lad to check stent result post placement.After withdrawing the eagle eye from the lad, a perforation was noticed in the distal diagonal branch.Covered stents and coil was applied to resolve the situation.Pericardial drain required.Patient left lab in stable condition.Case was completed in approximately 3.15 hrs.No device malfunction reported.
Additional Manufacturer Narrative
Internal reference: (b)(4).Block b5: added reason for reporting an adverse event.Block h6: added code 4755 (part/component/sub-assembly term not applicable) and 4614 (serious injury/ illness/impairment).
Event or Problem Description
This adverse event is being submitted because the patient experienced a perforation requiring additional intervention.
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer's policy.Block a1: patient identifier corrected from (b)(6) to (b)(6).Block d4: included catalog number.Block g4: the device was decontaminated on (b)(6) 2021.Blocks h3 & h6: the device was visually and microscopically inspected pre decontamination and no damage was observed.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.

• 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: 11634302
• Report Number: 2939520-2021-00015
• Device Sequence Number: 19674868
• Product Code: OBJ
• UDI-Device Identifier: 00845225002312
• UDI-Public: (01)00845225002312(11)210122(17)230122(10)0302143760
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2021

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: No Information
• Device Expiration Date: 01/22/2023
• Device Model Number: 85900PST
• Device Catalogue Number: 400-0200.141
• Device Lot Number: 0302143760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 04/09/2021; 06/06/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 05/03/2021; 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 84