MAUDE Adverse Event Report: PHILIPS VOLCANO VISIONS PV.014P RX DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 014R

Device Problems Material Separation (1562); Sharp Edges (4013)

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

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

Internal reference: (b)(4).Attempts to obtain patient information have been unsuccessful.Attempts to obtain the patient information were made via email.The implant or explant dates are not applicable to this device.

Event Description

This case was reviewed and investigated according to the manufacturer¿s policy.It was reported during a therapeutic peripheral procedure half of the image from the manufacture¿s device disappeared during the procedure.A second same device was used to complete the procedure.Procedure outcome was a completed angiogram and successful intervention.There is no patient injury.Patient was discharged as expected in good condition.The returned device was visually and microscopically inspected and damage was observed.There was a bend on the scanner.The scanner was highly damaged; exposed backing material and rough edges was observed.The probable cause of the observed failure is damage in use as evidenced by a bend on the scanner.Strain, impact, and forces associated with use can affect the integrity of the electrical connections within the device.It could not be determined when the cause of the failure 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 because the returned device was missing material and had rough edges.There is a potential for harm if the malfunction were to recur.

Manufacturer Narrative

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Event Description

This case was reviewed and investigated according to the manufacturer''s policy.Internal reference: (b)(4).This follow-up supplemental report #1 is being submitted to report additional investigation findings, to wit: there is no potential for harm if the malfunction were to recur.This complaint was reassessed based on an engineering study that indicated, this family of catheters do not exhibit any adhesive detachment during normal use.There is no evidence of abnormal use conditions, it is likely the adhesive detached post-procedure, during the process of returning the device for analysis.There was no patient injury, no status decline, no adverse event, and no unplanned additional medical or surgical intervention reported.There is no potential for harm if the malfunction were to recur.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.

Manufacturer Narrative

Block h6: supplemental report #1 indicated that the adhesive likely detached post procedure; however, the conclusion code was not updated from 4315 (cause not established) to 4308 (cause traced to transport/storage).

• Brand Name: VISIONS PV.014P RX DIGITAL IVUS 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: 8681264
• MDR Text Key: 148305768
• Report Number: 2939520-2019-00038
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002848
• UDI-Public: (01)00845225002848(17)201130(10)0301563875(90)989609001091
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K152829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,03/13/2019

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: 11/30/2020
• Device Model Number: 014R
• Device Catalogue Number: 400-0200.297
• Device Lot Number: 301563875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• 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
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 06/08/2019
• Supplement Dates Manufacturer Received: 01/14/2005; 12/13/2021
• Supplement Dates FDA Received: 03/30/2020; 12/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2018
• 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
• Treatment: 014 WIRE5FR PIM