BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORPATH GRX SYSTEM

    MDR report key: 6959675 · Received October 18, 2017

    Report

    Report Number
    3007822508-2017-00001
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Date of Event
    October 3, 2017
    Report Date
    October 17, 2017
    Manufacturer
    CORINDUS, INC
    Product Code
    DXX
    UDI-DI
    081628002304
    PMA / PMN Number
    K160121
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INDICATIONS FOR USE OF THE CORPATH GRX SYSTEM ARE: "THE CORPATH GRX SYSTEM IS INTENDED FOR USE IN THE REMOTE DELIVERY AND MANIPULATION OF GUIDEWIRES AND RAPID EXCHANGE BALLOON/STENT CATHETERS, AND REMOTE MANIPULATION OF GUIDE CATHETERS DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURES." THE NOVOSTE BETA-CATH DEVICE, WHILE A RAPID EXCHANGE CATHETER, IS NOT A BALLOON/STENT CATHETER AND THUS USE OF THE BETA-CATH DEVICE WITH THE CORPATH GRX SYSTEM IS OFF-LABEL. IN ADDITION, THE CORPATH GRX SYSTEM IS ONLY INTENDED FOR USE DURING PCI PROCEDURES, WHILE THE BETA-CATH SYSTEM IS INDICATED FOR USE POST-PCI PROCEDURE FOR THE TREATMENT OF IN-STENT RESTENOSIS. FURTHER, THE CORPATH GRX SYSTEM IS DESIGNED FOR USE WITH BALLOON/STENT CATHETERS WITH A POXIMAL SHAFT DIAMETER OF LESS THAN OR EQUAL TO 2.7 FR. THE BETA-CATH DEVICE HAS A PROXIMAL SHAFT DIAMETER OF 3.5 FR, AND IS THEREFORE INCOMPATIBLE WITH THE CORPATH GRX SYSTEM.

    Description of Event or Problem · 1

    THE PHYSICIAN USED THE CORPATH GRX SYSTEM IN AN ATTEMPT TO DRIVE A BETA-CATH SYSTEM FOR BRACH THERAPY. THE BETA-CATH CATHETER WAS CONNECTED THROUGH THE CORPATH GRX CASSETTE. THE RADIATION SOURCE FROM THE BETA-CATH SYSTEM WAS SENT OUT AND WAS NOT SEEN IN THE FLUORO. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE RADIATION SOURCE AND IT WOULD NOT RETRACT. THE PHYSICIAN THEN MANUALLY REMOVED THE BETA-CATH CATHETER. ONCE THE COVER OF THE CORPATH GRX CASSETTE WAS OPENED, THE RADIATION SOURCE RETURNED TO THE BETA-CATH SYSTEM. THE BETA-CATH CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED MANUALLY. IT WAS ESTIMATED BY THE SITE STAFF THAT THE INCIDENT CAUSED THE PHYSICIAN TO RECEIVE APPROXIMATELY 4.5 MSV OF RADIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738837 CORPATH GRX SYSTEM STEERABLE CATHETER CONTROL SYSTEM DXX CORINDUS, INC 304 081628002304

    Patients

    Seq Age Sex Outcome Treatment
    1 Other