BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORMA DIAGNOSTIC CARDIOLOGY CATHETER

    MDR report key: 3190174 · Received June 21, 2013

    Report

    Report Number
    1628221-2013-00013
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    January 1, 2013
    Report Date
    May 28, 2013
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K943739
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE USER DID NOT PROVIDE A LOT NUMBER. A GENERAL REVIEW OF THE COMPLAINT DATABASE FROM (B)(4) 2010 TO (B)(4) 2013, REVEALED TWO SIMILAR COMPLAINTS FROM THE SAME USER. NO SIMILAR COMPLAINTS HAVE BEEN REPORTED FROM ANY OTHER USER. NO SIMILAR COMPLAINTS HAVE BEEN REPORTED FROM ANY OTHER USER. MERIT IS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED FAILURE WITHOUT THE SUSPECT DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED IF MORE INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE USER REPORTED THAT DURING A CORONARY ANGIOGRAM PROCEDURE THE CATHETER CAUSED A DISSECTION OF THE RIGHT CORONARY ARTERY. THE USER REPORTED THAT THE PROCEDURE TOOK PLACE SOMETIME IN (B)(6) OF 2013. THE DATE OF EVENT PROVIDED IN THIS REPORT IS AN ESTIMATE. AFTER INITIAL PLACEMENT OF THE CATHETER THE PHYSICIAN NOTICED SLOW FLOW IN THE ARTERY AND CONFIRMED THE PRESENCE OF A DISSECTION USING A GUIDE WIRE AND GUIDING CATHETER. THE FLOW THROUGH THE ARTERY IMPROVED AND THE PT WAS TRANSFERRED TO THE CARDIAC CARE UNIT FOR OBSERVATION. AFTER OBSERVATION OVERNIGHT THE PT WAS DISCHARGED FROM THE HOSPITAL. THE USER DID NOT PROVIDED A CATALOG ITEM NUMBER OR LOT NUMBER FOR THE CATHETER USED AND DISCARDED THE SUSPECT DEVICE AT THE HOSPITAL. HOWEVER, SHIPPING HISTORY RECORDS INDICATE THAT THE USER WAS ONLY SENT (B)(4) CATHETERS THAT CONFORMED THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283634 PERFORMA DIAGNOSTIC CARDIOLOGY CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R CONTRAST MEDIA - SALINE| MANIFOLD - SYRINGE