BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN SELECT II

    MDR report key: 3071824 · Received April 22, 2013

    Report

    Report Number
    9612164-2013-00454
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K053431
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE MECHANICAL OPERATION OF THE CATHETER SHAFT WAS SEPARATED FROM THE HUB; THE MECHANICAL OPERATION OF THE CATHETER SHAFT WAS BENT AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ATTEMPT, WHILE ATTEMPTING TO SUB-SELECT A SPECIFIC CORONARY SINUS VEIN, THE PHYSICIAN DISSECTED THE CORONARY SINUS BODY. LATER, TWO LEFT VENTRICULAR (LV) LEADS WERE ATTEMPTED TO BE USED, BUT THE GUIDEWIRE LOCKED UP IN THE LEADS DURING LEAD PLACEMENT. THERE WAS A LOT OF RESISTANCE AND FRICTION WHILE MOVING THE GUIDEWIRE THROUGH THE LEADS. THE PHYSICIAN BELIEVED THAT BOTH OF THE LEADS WERE FLUSHED WITH A HALF-SALINE, HALF-CONTRAST SOLUTION PRIOR TO IMPLANT. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172632 ATTAIN SELECT II CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND 6248130D02 0006571475

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| L| R 6947 IMPLANTABLE TACHY LEAD