MAUDE Adverse Event Report: PHILIPS VOLCANO OMNIWIRE 89185; WIRE, GUIDE, CATHETER

Model Number 89185

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/28/2020

Event Type  malfunction  

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.Does not apply to this submission.Serial number is not applicable to this device.The implant or explant dates are not applicable to this device.Not applicable for this device.State/prefecture is (b)(6).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.

Event Description

This case was reviewed and investigated according to the manufacturers policy.It was reported during a planned diagnostic coronary procedure, before normalization inside the body, the pd and pa were different (above 20 mmhg).The returned device was visually and microscopically inspected, ptfe coating over the composite core was missing, it was measured to be bigger than 1 square millimeter, no rough or sharp edges observed.The wire passed functional tests.The investigation was unable to determine conclusive how the missing ptfe on the composite core occurred.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.This product problem is being submitted in an abundance of caution as it could not be determined where or when the alleged separation occurred.There is a potential for harm if the alleged separation were to recur.

• Brand Name: OMNIWIRE 89185
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone & business park; b37; alajuela ; CS
• Manufacturer Contact: melissa mangum ; 2870 kilgore road; rancho cordova, CA 95670 ; 8584650468
• MDR Report Key: 11346873
• MDR Text Key: 243973880
• Report Number: 2939520-2021-00010
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00845225003043
• UDI-Public: (01)00845225003043(11)201026(17)221026(10)0302060824
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K192886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2022
• Device Model Number: 89185
• Device Catalogue Number: 300000252871
• Device Lot Number: 0302060824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1