BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FELEXIBLE INTRODUCER CANNULA

    MDR report key: 3750330 · Received January 31, 2014

    Report

    Report Number
    1316297-2014-00001
    Event Type
    Malfunction
    Date Received
    January 31, 2014
    Date of Event
    January 7, 2014
    Report Date
    January 29, 2014
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Product Code
    MIA
    PMA / PMN Number
    051860
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: ON (B)(6) 2014, EPIMED EXAMINED THE FLEXIBLE INTRODUCER CANNULA (FIC) IN QUESTION. DURING VISUAL INSPECTION, THE FIC'S FLEXIBLE CANNULA HAD STRETCHED APPROX TWICE ITS ORIGINAL LENGTH. FURTHERMORE, IT APPEARS THAT THE CANNULA BECAME PINCHED/CAUGHT WITHIN THE PT'S BONE STRUCTURE AT APPROX 4.5CM FROM THE CANNULA'S DISTAL END. IT APPEARS THAT ONCE THE CANNULA BECAME PINCHED/CAUGHT, FURTHER ATTEMPTS OF REMOVAL WERE MADE WHICH CAUSED THE CANNULA BODY TO STRETCH. INSTEAD, THE PHYSICIAN MADE THE DECISION TO CUT THE FIC'S CANNULA INTO TWO SECTIONS SO THAT THE CANNULA COULD BE REMOVED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, EPIMED'S QUALITY ASSURANCE DEPT WAS NOTIFIED OF AN EVENT THAT HAD RECENTLY OCCURRED INVOLVING EPIMED'S FLEXIBLE INTRODUCER CANNULA (FIC), (CATALOG # 135-1735). DURING REMOVAL OF THE FIC, THE PHYSICIAN (DR. (B)(6)) REPORTED "THAT HE REALIZED THAT THE CANNULA HAD STRETCHED. AFTER FURTHER ATTEMPTS WERE MADE TO REMOVE THE CANNULA, THE DECISION WAS MADE TO CUT IT WHICH ENABLED THEM TO REMOVE BOTH SECTIONS OF THE CANNULA. THE PT'S SAFETY WAS NOT COMPROMISED AT ANY TIME, BUT THE PT HAD TO UNDERGO SURGICAL EXPLORATION OF THE CAUDAL HIATUS TO REMOVE THE CANNULA. THERE WERE A FEW STITCHES BUT UNEVENTFUL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66869 FELEXIBLE INTRODUCER CANNULA INTRODUCER CANNULA MIA EPIMED INTERNATIONAL, INC. 135-1735 12355382

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention