BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY CATHETER

    MDR report key: 4131720 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14418
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING CATHETER USE, THE PHYSICIAN PERFORATED THE PATIENT'S LATERAL LEFT VENTRICULAR (LV) VEIN WHILE SEARCHING FOR OPTIMAL LV LEAD PLACEMENT. THE PHYSICIAN PROCEEDED WITH PERICARDIAL DRAINAGE AND THE PATIENT WAS REPORTED AS WELL. A DECISION WAS REACHED TO FORGO LV LEAD IMPLANT AND ANOTHER DEVICE THEN SELECTED FOR IMPLANT TO COMPLETE THE PROCEDURE. THE FIELD REPRESENTATIVE MET WITH THE PHYSICIAN POST-IMPLANT. THE PHYSICIAN STATED THAT AT NO TIME, WAS A BOSTON SCIENTIFIC PRODUCT ALLEGED TO HAVE CAUSED OR CONTRIBUTED TO THE VESSEL PERFORATION. THE PHYSICIAN STATED IT WAS DIRECTLY RELATED TO A PATIENT ANATOMIC CONDITION. NO RETURN OF PRODUCT IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612179 ACUITY CATHETER GUIDE CATHETER DQY EXTERNAL MANUFACTURER 8103

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R