BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERCROSS

    MDR report key: 5100574 · Received September 24, 2015

    Report

    Report Number
    2183870-2015-00337
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    December 16, 2014
    Report Date
    December 26, 2014
    Manufacturer
    PLYMOUTH-PA
    Product Code
    DQY
    PMA / PMN Number
    K110319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN (B)(4) LOCATION, FOLLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN. A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING. (B)(4).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, THE PHYSICIAN USED AN EVERCROSS PTA BALLOON CATHETER TO TREAT A LESION IN LEFT SFA WITH 90% STENOSIS. POST TREATMENT BY PTA BALLOONING, THE LESION EXHIBITED 20% RESIDUAL STENOSIS. APPROXIMATELY 13 MONTHS LATER THE PATIENT PRESENTED WITH CRAMPING IN THE LEFT LOWER LIMB. NON-INVASIVE STUDIES SHOWED OCCLUSION OF THE PREVIOUSLY TREATED TARGET LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630401 EVERCROSS CATHETER, PERCUTANEOUS DQY PLYMOUTH-PA AB35W05120135V02 9799524

    Patients

    Seq Age Sex Outcome Treatment
    1 Other