BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMOPAC ST+ F5 W/CSI

    MDR report key: 2900209 · Received January 7, 2013

    Report

    Report Number
    9616099-2013-00006
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K862244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE CATH F5.2+ PIG 145 110CM 6SH CATHETER SEPARATED DURING POSITIONING IN THE LEFT ATRIUM WITHOUT ANY MECHANICAL INFLUENCE OR MANIPULATION BY THE HEALTH PROFESSIONAL. FURTHER DAMAGE OUTSIDE THE CATHETER IS VISIBLE. THE CATHETER COULD BE REMOVED BY USING A GOOSE SNARE. NO PATIENT CONSEQUENCES HAVE BEEN OBSERVED. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO OPENING. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITH NO PROBLEMS NOTED. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6543 PRIMOPAC ST+ F5 W/CSI DIAGNOSTIC CARDIOLOGY CATHETER (DQO) DQO CORDIS DE MEXICO NA 15704650

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R