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

Model Number 85900PJ

Device Problem Material Separation (1562)

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

Event Date 10/18/2018

Event Type  malfunction  

Manufacturer Narrative

Internal reference: (b)(4).Facility declined to provide patient information of id, gender, age and weight.The implant or explant dates are not applicable to this device.Concomitant medical products: no information available.State/prefecture is (b)(6).Insert investigation findings and appropriate case details here.

Event Description

This case was reviewed and investigated according to the manufacturer¿s policy.It was reported during a planned therapeutic coronary procedure, inside the body, tracking over the horn, the image on the manufacture's device disappeared.There is no patient injury.Access location; femoral, calcification; none.The returned device was visually and microscopically inspected and damage was observed.A portion of the adhesive at the proximal fillet, a portion of the adhesive at the distal fillet, and a portion of kapton scanner material were missing.The pzt array was scratched.The probable cause of the observed missing adhesive and kapton scanner material is damage, as evidenced by the scratches present at the distal fillet, proximal fillet, and pzt array.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 portions of the manufacture's device were missing.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: EAGLE EYE PLATINUM 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: 8285508
• MDR Text Key: 136614893
• Report Number: 2939520-2019-00019
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225001339
• UDI-Public: (01)00845225001339(17)200630(10)0301476828(90)989609001101
• 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
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,10/19/2018

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: 06/30/2020
• Device Model Number: 85900PJ
• Device Catalogue Number: 400-0200.71
• Device Lot Number: 301476828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• 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: 11/12/2018
• Initial Date FDA Received: 01/29/2019
• Supplement Dates Manufacturer Received: 01/14/2005; 12/13/2021
• Supplement Dates FDA Received: 02/22/2020; 12/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2018
• 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