BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPULSE GUIDE CATHETERS

    MDR report key: 1894224 · Received November 9, 2010

    Report

    Report Number
    2134265-2010-05064
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQO
    PMA / PMN Number
    K992142
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: PATIENT IS IN HER (B)(6). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT HEART CATHETERIZATION DIAGNOSTIC PROCEDURE A SHAFT FRACTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. AS THE IMPULSE DIAGNOSTIC CATHETER WAS INSERTED IT WAS NOTED THAT THE FEMORAL ARTERY WAS EXTREMELY TORTUOUS IN THE DILATED ROOT. THE PHYSICIAN HAD TO "CONTINUOUSLY TORQUE" THE DEVICE IN ORDER TO ADVANCE IT. DURING ADVANCEMENT, THE SHAFT FRACTURED 17CM FROM THE PROXIMAL END AT THE SHEATH INSIDE THE FEMORAL ARTERY. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT WAS TAKEN TO SURGERY TO HAVE THE DETACHED IMPULSE CATHETER SHAFT REMOVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPULSE GUIDE CATHETERS CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - MAPLE GROVE H749165993020

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention