MAUDE Adverse Event Report: PHILIPS VOLCANO S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM; S5X SYSTEM

Model Number S5TOW02

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 01/28/2020

Event Type  Injury  

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.No tests/laboratory data was available.No information was available.Lot number: this "blank" is not an omission.There is no expiration date associated with this product.Expiration date: this "blank" is not an omission.There is no lot associated with this product; it is referenced by serial number.Udi number: this "blank" is not an omission.The udi # is not applicable; the system was manufactured prior to 09-24-2016.The implant or explant dates are not applicable to this device.No information available.The system was analyzed at the customer facility by the manufacturer's field service engineer (fse).The fse was unable to verify customer reported issue.The fse was unable to retrieve study data from system or angio as all data had been deleted by customer prior to fse arriving onsite.

Event Description

It was reported that after using the manufacturer's system, a patient's superficial femoral artery (sfa) was ballooned and perforated by another manufacture¿s device.This adverse event (ae) is being submitted because the manufacture¿s device is a concomitant device in a procedure where the ae of vessel perforation from another manufacture¿s device occurred.

Manufacturer Narrative

Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Block g4: the initial report submitted 02/26/2020 had an inadvertent entry error of (b)(6) 2020.Correct date is (b)(6) 2020.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.

Event Description

This follow-up supplemental report #1 is being submitted to correct an inadvertent entry error in g4, the date received by manufacturer (becomes aware date).

Manufacturer Narrative

Block g: the supplemental follow-up #1 submitted on 3/7/2021 had an inadvertent entry error of (b)(6) 2021.Correct date is (b)(6) 2020.

• Brand Name: S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM
• Type of Device: S5X SYSTEM
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer Contact: melissa mangum ; 2870 kilgore road; rancho cordova, CA 95670 ; 8584650468
• MDR Report Key: 9754040
• MDR Text Key: 192672115
• Report Number: 2939520-2020-00006
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K173860
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: S5TOW02
• Device Catalogue Number: 807300001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention