BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MO.MA. ULTRA 6F ID

    MDR report key: 3915339 · Received July 7, 2014

    Report

    Report Number
    3004066202-2014-00103
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    December 17, 2013
    Report Date
    June 9, 2014
    Manufacturer
    INVATEC SPA
    Product Code
    NTE
    PMA / PMN Number
    K092177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: PATIENT CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PHYSICIAN COMMENTED THAT DIFFICULTY TO BLOCK THE BLOOD FLOW WAS DUE TO ANATOMIC LOCATIONS). NO DEVICE RETURNED. NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). EVALUATION CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PHYSICIAN COMMENTED THAT DIFFICULTY TO BLOCK THE BLOOD FLOW WAS DUE TO ANATOMIC LOCATIONS). UNABLE TO CONFIRM COMPLAINT (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO USE A MO.MA ULTRA 6F ID CEREBRAL PROTECTION DEVICE TO TREAT A LESION IN THE LEFT ICA WHICH EXHIBITED 60% STENOSIS. VESSEL DIAMETER: 6.2-9.88 MM, LESION TYPE: ULCERATION. BIFURCATION OF THE SUPERIOR THYROID ARTERY (STA) WAS THE PROXIMAL SIDE OF MO.MA BALLOON. TYPE OF AORTA: TYPE I. PHYSICIAN SUCCESSFULLY DELIVERED THE MO.MA TO THE LESION AND INFLATED THE PROXIMAL/DISTAL BALLOON. HOWEVER, THE DEVICE FAILED TO BLOCK THE BLOOD FLOW AS THE BIFURCATION OF STA WAS THE PROXIMAL SIDE OF MO.MA BALLOON. THE PHYSICIAN USED ANOTHER PROTECTION DEVICE (NON-MEDTRONIC) AND COMPLETED THE PROCEDURE. TWENTY % STENOSIS REMAINED AFTER STENTING PROCEDURE. NO HEALTH HAZARD WAS CAUSED TO THE PATIENT. PHYSICIAN COMMENTED THAT DIFFICULTY TO BLOCK THE BLOOD FLOW WAS DUE TO ANATOMIC LOCATIONS. IT WAS REPORTED THAT THE EVENT WAS NOT RELATED TO THE DEVICE AND PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394623 MO.MA. ULTRA 6F ID CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE NTE INVATEC SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR