BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN SELECT II

    MDR report key: 4830730 · Received June 10, 2015

    Report

    Report Number
    9612164-2015-00929
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    March 11, 2015
    Report Date
    March 11, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K123153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE CATHETER WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THAT THE MECHANICAL OPERATION OF THE CATHETER SHAFT WAS SEPARATED FROM THE HUB. ADDITIONALLY, THE MECHANICAL OPERATION OF THE CATHETER SHAFT WAS BENT. THE ANALYST NOTED THAT THE SLITTER WAS NOT RETURNED. THE MODEL OR CONDITION OF THE SLITTER COULD NOT BE CONFIRMED. THE CATHETER WAS RETURNED WITH THE HUB SEPARATED FROM THE SHAFT AND WITH SEVERAL KINKS IN THE SHAFT. SPIRAL SLITTING WAS NOT OBSERVED AND DOES NOT APPEAR TO BE A FACTOR IN THE HUB SEPARATION. IT APPEARS THAT THE HUB/SHAFT SEPARATION OCCURRED WITHIN THE HUB/HANDLE. OTHER THAN SLITTING, NO UNUSUAL CUTTING WAS OBSERVED ON THE HUB. IT IS LIKELY THAT THE SHAFT WAS PULLED WITH SEVERE FORCE OUT OF THE HUB DURING USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE ENTIRE HEMOSTATIC VALVE AND HUB FELL OFF OF THE CATHETER HALF WAY THROUGH SLITTING THE SHEATH. IT WAS NOTED THAT PHYSICIAN STARTED TO CUT THE CATHETER WITH IRIS SCISSORS THE REMAINING DISTANCE AND THEN REALIZED THEY COULD HOLD ON TO THE ALREADY SLIT END, REENGAGE THE SLITTER AND COMPLETE THE PROCEDURE WITHOUT FURTHER SEQUELA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373442 ATTAIN SELECT II CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND 6248V-130 0007386526

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR