BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERFORM

    MDR report key: 4912354 · Received July 14, 2015

    Report

    Report Number
    2029214-2015-00786
    Event Type
    Malfunction
    Date Received
    July 14, 2015
    Date of Event
    June 6, 2015
    Report Date
    June 17, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MJN
    PMA / PMN Number
    K011656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EVENT CAUSE COULD NOT BE DETERMINED. THE LOT HISTORY RECORD REVIEW OF THE REPORTED LOT NUMBER SHOWED NO DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EXPERIENCE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED FOR EVALUATION WITHOUT THE GUIDEWIRE, THEREFORE, ANY CONTRIBUTING FACTORS FROM THE GUIDEWIRE COULD NOT BE ASSESSED. UPON EXAMINATION OF THE CATHETER, A HOLE (NOT RUPTURE) IN THE CHRONOPRENE TUBING WAS FOUND NEAR THE DISTAL MARKER BAND. AN UNSUCCESSFUL ATTEMPT WAS MADE TO FLUSH THE CATHETER AS IT WAS FOUND TO BE OCCLUDED WITH WHAT IS LIKELY CONTRAST. AFTER SOAKING THE CATHETER DEVICE, IT WAS THEN ABLE TO BE SUCCESSFULLY FLUSHED WITH WATER AS IT WAS FOUND PATENT. AN IN-HOUSE GUIDEWIRE WAS THEN INSERTED INTO AND THROUGH THE CATHETER LUMEN WITHOUT ISSUE. AN UNSUCCESSFUL ATTEMPT WAS MADE TO INFLATE THE BALLOON, AS IT WAS FOUND TO BE LEAKING AT THE LOCATION OF THE HOLE. NO OTHER ANOMALIES WERE OBSERVED. THE BALLOON CATHETER WAS FOUND TO BE DAMAGED; HOWEVER, THE CAUSE FOR THE DAMAGE COULD NOT BE DETERMINED. NOTE: PER THE BALLOON INSTRUCTIONS FOR USE (IFU) DIRECTIONS FOR USE: "BALLOON CANNOT INFLATE UNLESS A PORTION OF THE DISTAL 10 CM OF THE GUIDEWIRE TIP IS OCCLUDING THE DISTAL INFLATION HOLES OF THE CATHETER." IN ADDITION, THE FOLLOWING PRECAUTION IS NOTED: "USE ONLY THE RECOMMENDED BALLOON INFLATION MEDIUM OF 50:50 SOLUTION BY VOLUME OF 60% CONTRAST MEDIUM AND NORMAL, STERILE SALINE." THE LOT HISTORY RECORD REVIEW OF THE REPORTED LOT NUMBER SHOWED NO DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EXPERIENCE. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE BALLOON TEST INFLATION, THE BALLOON WAS REPORTED TO HAVE IMMEDIATELY RUPTURED. CADENCE SYRINGE WAS USED, CONTRAST RATIO WAS 75% SALINE. THE X-PEDION GUIDEWIRE TIP WAS NOT SHAPED. A 15 CM OF THE GUIDEWIRE WAS ADVANCE OUT OF THE CATHETER TIP. THE PATIENT WAS NOT REPORTED TO HAVE BEEN INJURED AND A NEW DEVICE WAS USED TO TREAT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455561 HYPERFORM CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN COVIDIEN (IRVINE) 104-4470 9945328

    Patients

    Seq Age Sex Outcome Treatment
    1