BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPO GUIDE CATHETER

    MDR report key: 2760295 · Received September 26, 2012

    Report

    Report Number
    2134265-2012-06191
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    August 28, 2012
    Report Date
    August 28, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQO
    PMA / PMN Number
    K992142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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 PREPARATION FOR A PERCUTANEOUS TREATMENT PROCEDURE, A DEVICE BECAME CONTAMINATED.LESION DETAILS ARE UNKNOWN. WHEN OPENING THIS 6F EXPO MPA1 GUIDE CATHETER, THE PACKAGE WAS TORE OPEN AT AN ANGLE AND THE CATHETER BECAME CONTAMINATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME EXPO GUIDE CATHETERS. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPO GUIDE CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - MAPLE GROVE H749086411171

    Patients

    Seq Age Sex Outcome Treatment
    1