BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERIT HEMOSTASIS VALVE

    MDR report key: 2050955 · Received April 4, 2011

    Report

    Report Number
    9616662-2011-00024
    Event Type
    Injury
    Date Received
    April 4, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTL
    PMA / PMN Number
    K042060
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER, THEREFORE, THE DESIGN HISTORY FILE AND COMPLAINT DATABASE COULD NOT BE REVIEWED. THREE SEPARATE ATTEMPTS WERE MADE ON (B)(4) 2011 TO OBTAIN ADDITIONAL CLINICAL INFORMATION FROM THE CUSTOMER . THE CUSTOMER WOULD NOT DIVULGE ANY FURTHER INFORMATION. THE CUSTOMER STATED THEY WERE NOT AWARE IF THIS WAS THE INITIAL USE OF THE DEVICES IN QUESTION. UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAILURE WITHOUT THE SUSPECT DEVICE. NO CONCLUSION CAN BE DRAWN. EVAL: DEVICE HISTORY FILE AND COMPLAINT DATABASE COULD NOT BE REVIEWED AS NO LOT NUMBER WAS GIVEN. RESULTS: UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAILURE. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AIR WAS DRAWN INTO THE SYSTEM WHILE USING THE HEMOSTASIS VALVE ON TWO SEPARATE OCCASIONS DURING ANGIOPLASTY PROCEDURES. ONE PATIENT WENT INTO ARREST, BUT WAS RESUSCITATED. NO SPECIFIC CLINICAL INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER FOR THE SECOND EVENT. THE CUSTOMER WILL NOT PROVIDE ANY FURTHER INFORMATION FOR THE PATIENT THAT REPORTEDLY ARRESTED. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER, AND WILL NOT BE RETURNING ANY SUSPECT DEVICES FOR EVALUATION. THIS IS ONE OF TWO REPORTS FOR THIS COMPLAINT. 9616662-2011-00025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT HEMOSTASIS VALVE ADAPTOR, STOPCOCK, MANIFOLD, FITTING DTL MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R STANDARD PROCEDURAL TRAYS