BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN SELECT

    MDR report key: 2813065 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03819
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 9, 2012
    Report Date
    December 5, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQY
    PMA / PMN Number
    K042194
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE CATHETER WAS RETURNED AND ANALYZED. THE CATHETER TIP WAS BROKEN OFF AT 67.5 CM FROM THE HANDLE AND THE TIP WAS NOT RETURNED. THERE APPEARED TO BE A SLIGHT KINK IN THE CATHETER SHAFT NEAR THE BROKEN TIP SITE, AND APPEARED DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE CANNULATING THE CORONARY SINUS AND TRYING TO PLACE THE LEFT VENTRICULAR (LV) LEAD THE TELESCOPIC CATHETER'S TIP BROKE INSIDE THE CORONARY SINUS. THE DOCTOR REMOVED THAT BROKEN TIP. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN SELECT CATHETER, PERCUTANEOUS DQY MEDTRONIC, INC. 6238TEL FA39502

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention