BEUDAMED
    FDA Adverse Event Other Summary report: N

    MINI ONE

    MDR report key: 2976446 · Received January 9, 2013

    Report

    Report Number
    1526012-2012-00002
    Event Type
    Other
    Date Received
    January 9, 2013
    Date of Event
    October 19, 2012
    Report Date
    December 6, 2012
    Manufacturer
    APPLIED MEDICAL
    Product Code
    KNT
    PMA / PMN Number
    K980305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON A REVIEW OF THE INFO, THE INCIDENT IS NOT A REPORTABLE EVENT PER 21 CFR, SECTION 803. THERE WAS NO DEATH. THERE WAS NO SERIOUS INJURY, AS DEFINED BY THE FDA. THIS WAS NOT LIFE-THREATENING, NOR DID THIS RESULT IN PERMANENT IMPAIRMENT OR NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT. BASED ON A REVIEW OF THE INFO, THE DEVICE WAS REMOVED ACCORDING TO THE APPLIED MEDICAL TECHNOLOGIES (AMT) DIRECTIONS FOR USE AND THERE WAS NO REPORTED PT HARM. ENDOSCOPIC REMOVAL AND SEDATION IS OFTEN USED WHEN REMOVING/REPLACING NON-BALLOON DEVICES, AND CAN BE PERFORMED AT THE PHYSICIAN'S DISCRETION. AMT DIRECTIONS FOR USE INCLUDE A RECOMMENDED REMOVAL PROCEDURE WITH ADD'L METHODS FOR REMOVAL THAT ARE COMMONLY USED. THE RECOMMENDED METHOD INCLUDES USING A SUPPLIED REMOVAL TOOL TO REMOVE THE DEVICE. IN SOME CASES THE DOCTOR MAY CHOOSE TO USE ONE OF THE ADD'L METHODS FOR REMOVAL. DFU EXCERPTS OF ADD'L METHODS ARE LISTED BELOW: IF RESISTANCE IS NOT OBSERVED WHEN RATCHETING DOWN THE SNAP ARM, REMOVE THE SNAP ARM AND T-HANDLE AND REMOVE THE DEVICE VIA TRACTION. ADD'L METHODS FOR REMOVAL: THE MINIONE NON BALLOON BUTTON CAN ALSO BE TRACTION REMOVED WITHOUT ELONGATING THE DEVICE. GRASP THE TABS, APPLY CONSTANT TRACTION AND CAREFULLY REMOVE THE DEVICE. IF TRACTION PROVIDES TOO MUCH STRESS TO THE PT, THE CATHETER CAN BE CUT AT SKIN LEVEL AND THE INTERNAL BOLSTER REMOVED ENDOSCOPICALLY. IN ADDITION, A DHR REVIEW SHOWED NO ANOMALIES. NOR WAS THE AMT DEVICE RETURNED TO AMT FOR ANALYSIS. IT SHOULD ALSO BE NOTED THAT THE AMT REPLACEMENT DEVICE IS A DISPOSABLE DEVICE, REQUIRING PERIODIC REPLACEMENT. AMT WILL PROVIDE ADD'L INFO TO THE FDA WHEN/IF THE DEVICE IS ABLE TO BE RETRIEVED AND ANALYSIS OF THE DEVICE CHANGES THE CONCLUSION OF THIS REPORT.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13492 MINI ONE TUBE, GASTROSTOMY KNT APPLIED MEDICAL 11081360

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR