BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAGLE EYE PLATINUM SHORT TIP CATHETER

    MDR report key: 8276545 · Received January 24, 2019

    Report

    Report Number
    2939520-2019-00015
    Event Type
    Malfunction
    Date Received
    January 24, 2019
    Date of Event
    September 10, 2018
    Report Date
    September 10, 2018
    Manufacturer
    PHILIPS VOLCANO
    Product Code
    OBJ
    UDI-DI
    00845225002312
    PMA / PMN Number
    K143701
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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).

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : PLACEHOLDER

    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). STATE/PREFECTURE IS (B)(6).

    Description of Event or Problem · 1

    THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED THAT DURING A THERAPEUTIC DIAGNOSTIC PROCEDURE THE MANUFACTURER'S DEVICE LOST IMAGE. VISUAL, MICROSCOPIC INSPECTION, AND FUNCTIONAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. PORTIONS OF ADHESIVE WERE MISSING ON THE DISTAL FILLET. ADHESIVE WAS PRESENT ON THE PZT ARRAY. THE DEVICE WAS RECOGNIZED BY THE SYSTEM BUT AN INCOMPLETE INTERMITTENT IMAGE WAS OBSERVED. THE PROBABLE CAUSE OF THE REPORTED LOST IMAGE FAILURE IS ADHESIVE PRESENT ON THE PZT ARRAY. THE PROBABLE CAUSE OF THE OBSERVED MISSING ADHESIVE ON THE DISTAL FILLET COULD NOT BE CONCLUSIVELY DETERMINED BY THE INVESTIGATION. 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
    66946 EAGLE EYE PLATINUM SHORT TIP CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ PHILIPS VOLCANO 85900PST 0301469703 00845225002312

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown