BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAGLE EYE PLATINUM CATHETER

    MDR report key: 8276190 · Received January 24, 2019

    Report

    Report Number
    2939520-2019-00013
    Event Type
    Malfunction
    Date Received
    January 24, 2019
    Date of Event
    September 11, 2018
    Report Date
    September 19, 2018
    Manufacturer
    PHILIPS VOLCANO
    Product Code
    OBJ
    UDI-DI
    00845225001278
    PMA / PMN Number
    K143701
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : PLACEHOLDER.

    Additional Manufacturer Narrative · 0

    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).

    Description of Event or Problem · 0

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED THAT DURING A DIAGNOSTIC CORONARY PROCEDURE, THE MANUFACTURER'S DEVICE PRODUCED A PARTIAL IMAGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SECOND OF THE SAME MAKE AND MODEL. VISUAL, MICROSCOPIC INSPECTION, AND FUNCTIONAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. THE DISTAL FILLET AND PZT ARRAY WERE SCRATCHED, SMALL PORTIONS OF ADHESIVE WERE MISSING. THE DEVICE WAS RECOGNIZED BY THE SYSTEM BUT NO IMAGE WAS PRODUCED. THE PROBABLE CAUSE OF THE REPORTED PARTIAL IMAGE FAILURE AND THE OBSERVED MISSING ADHESIVE IS THE OBSERVED DAMAGE TO THE DEVICE. STRAIN, IMPACT, AND FORCES ASSOCIATED WITH USE CAN AFFECT THE INTEGRITY OF THE DEVICE. HOWEVER, IT COULD NOT BE DETERMINED WHEN AND HOW THE DEVICE WAS DAMAGED. 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 ADHESIVE WAS MISSING FROM THE DEVICE, IT COULD NOT CONCLUSIVELY BE DETERMINED WHEN THE SEPARATION OCCURRED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68701 EAGLE EYE PLATINUM CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ PHILIPS VOLCANO 85900P 0301465789 00845225001278

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown