BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAGLE EYE PLATINUM CATHETER

    MDR report key: 8263028 · Received January 18, 2019

    Report

    Report Number
    2939520-2019-00011
    Event Type
    Malfunction
    Date Received
    January 18, 2019
    Date of Event
    November 6, 2018
    Report Date
    November 7, 2018
    Manufacturer
    PHILIPS VOLCANO
    Product Code
    OBJ
    UDI-DI
    00845225001339
    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).

    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). FACILITY DECLINED TO PROVIDE PATIENT ID, GENDER, AGE AND WEIGHT. ATTEMPTS TO OBTAIN PATIENT INFORMATION WERE MADE VIA EMAIL. THE IMPLANT OR EXPLANT DATES ARE NOT APPLICABLE TO THIS DEVICE.

    Description of Event or Problem · 1

    THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED DURING A PLANNED THERAPEUTIC CORONARY PROCEDURE INSIDE THE BODY, DURING PULLBACK OR RECORDING, THE ERROR MESSAGE "CATHETER FAULT DETECTED" WAS DISPLAYED ON THE MANUFACTURE'S DEVICE. THE SYSTEM WAS RESTARTED BUT THE PROBLEM WAS NOT SOLVED. THERE IS NO PATIENT INJURY. THE RETURNED DEVICE WAS VISUALLY AND MICROSCOPICALLY INSPECTED. SCRATCHES WERE PRESENT AT THE DISTAL FILLET AND PZT ARRAY. THE DEVICE WAS MISSING PORTIONS OF ADHESIVE FROM THE DISTAL FILLET AS ADHESIVE TAPERED DOWN ON BOTH ENDS SCANNER AND TIP) ARE LIFTED AND HAD ROUGH EDGES FROM THE DAMAGE SUSTAINED. THE PROBABLE CAUSE OF THE OBSERVED MISSING ADHESIVE IS DAMAGE, AS EVIDENCED BY THE SCRATCHES PRESENT AT THE DISTAL FILLET AND PZT ARRAY. STRAIN, IMPACT, AND FORCES ASSOCIATED WITH USE CAN AFFECT THE INTEGRITY OF THE DEVICE. IT T WAS NOT POSSIBLE TO DETERMINE WHEN AND HOW 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 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
    52511 EAGLE EYE PLATINUM CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ PHILIPS VOLCANO 85900PJ 0301498205 00845225001339

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown