BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAGLE EYE PLATINUM ST CATHETER

    MDR report key: 9760430 · Received February 27, 2020

    Report

    Report Number
    2939520-2020-00007
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Date of Event
    November 13, 2019
    Report Date
    November 14, 2019
    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

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REFERENCE: 122685. FACILITY DECLINED TO PROVIDE PATIENT INFORMATION. NO INFORMATION AVAILABLE. THE IMPLANT OR EXPLANT DATES ARE NOT APPLICABLE TO THIS DEVICE. STATE/PREFECTURE IS (B)(6). DO NOT APPLY TO THIS SUBMISSION. 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.

    Description of Event or Problem · 1

    THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. IT WAS REPORTED DURING A PLANNED DIAGNOSTIC PERIPHERAL PROCEDURE, INSIDE THE BODY, WHILE PASSING THROUGH THE LESION THE IMAGE WAS LOST. ANOTHER OF THE SAME PRODUCT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION PROVIDED PER THE CUSTOMER COMPLAINT FORM INDICATED NO PART WAS DAMAGED AND NO DETACHED PARTS OBSERVED ON THE DEVICE AFTER REMOVAL FROM THE PATIENT. THE RETURNED DEVICE WAS VISUALLY AND MICROSCOPICALLY INSPECTED. THE PROXIMAL FILLET AND SCANNER WERE DAMAGED. A PORTION OF KAPTON WAS LIFTED NEAR THE SEAM SEAL, THE BACKING MATERIAL BENEATH THE LIFTED KAPTON WAS EXPOSED, NO MISSING BACKING MATERIAL OR KAPTON MATERIAL OBSERVED. THE PROBABLE CAUSE OF THE DAMAGE COULD NOT BE DETERMINED DURING THE INVESTIGATION. HOWEVER, STRAIN, IMPACT, AND FORCES ASSOCIATED WITH USE CAN AFFECT THE INTEGRITY OF THE DEVICE. IT COULD NOT BE DETERMINED WHEN THE DAMAGE 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 MANUFACTURER¿S RETURNED DEVICE HAD ROUGH EDGES. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228704 EAGLE EYE PLATINUM ST CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ PHILIPS VOLCANO 85900PST 0301718473 00845225002312

    Patients

    Seq Age Sex Outcome Treatment
    1