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

Model Number 85900PST

Device Problem Material Separation (1562)

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

Event Date 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

Internal reference: (b)(4).Facility declined to provide patient information.No information available.The implant or explant dates are not applicable to this device.Not applicable for this device.No information available.State/prefecture is (b)(6).The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.

Event Description

This case was reviewed and investigated according to the manufacturer¿s policy.It was reported during a therapeutic peripheral procedure the image disappeared from the manufacturer's device.A second same device was used to complete the procedure.Additional information provided per the customer complaint form indicated no part was damaged and no detached parts observed on the device after removal from the patient.The returned device was visually and microscopically inspected and damage was observed.There was a portion of kapton missing, the backing material was exposed on this section, small rough edges of kapton material were observed.The probable cause of the observed failure could not be determined.Device manipulation, impact and applied pressure associated with use and handling can affect the integrity of the device.This product problem is being submitted because the returned device was missing material and had rough edges.There is a potential for harm if the malfunction were to recur.

• Brand Name: EAGLE EYE PLATINUM ST CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• 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: 9584542
• MDR Text Key: 220009434
• Report Number: 2939520-2019-00060
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002312
• UDI-Public: (01)00845225002312(17)210930(10)0301736667(90)989609000481
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K143701
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,11/28/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 85900PST
• Device Catalogue Number: 400-0200.141
• Device Lot Number: 0301736667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 01/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2019
• 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