BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACHIEVE MAPPING CATHETER

    MDR report key: 3193502 · Received June 27, 2013

    Report

    Report Number
    3007798852-2013-00011
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    MEDTRONIC ABLATION FRONTIERS
    Product Code
    DRF
    PMA / PMN Number
    K102588
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN SENT TO THE MANUFACTURER FOR EVALUATION; RESULTS OF EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS RECEIVED WITH SIGNAL WIRES EXPOSED BUT CONNECTED AND ALMOST ALL OF THE PEBAX TUBING MISSING. THE MAPPING CATHETER WAS RECEIVED INSERTED IN THE GUIDE WIRE LUMEN OF THE CRYOABLATION CATHETER. PARTICLES OF THE DISINTEGRATED PEBAX TUBING WERE ALSO RETURNED. THE REPORTED ISSUE WAS CONFIRMED THROUGH THE VISUAL INSPECTION. INSPECTION OF THE CRYOABLATION CATHETER DID NOT EXHIBIT ANY FAILURE THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE WAS SENT OUT TO AN INDEPENDENT LAB FOR ANALYSIS ON THE FEW PARTICLES THAT REMAINED. ANALYSIS SHOWED THAT THE RETURNED SAMPLE HAS A MUCH LOWER MOLECULAR WEIGHT THAN THE CONTROL SAMPLE, INDICATING THAT A SEVERE DEGRADATION OCCURRED. WEIGHT AVERAGED MOLECULAR WEIGHT OF THE BRITTLE RETURN SAMPLE WAS 13% OF THE COMPARATIVE CONTROL SAMPLE INDICATING THE PEBAX MATERIAL HAD MINIMAL MECHANICAL STRENGTH. THIS SUPPORTED THE DEGRADATION AND EMBRITTLED CONDITION. NO FURTHER DEGRADATION MECHANISM ANALYSIS WAS POSSIBLE DUE TO THE LIMITED SAMPLE AMOUNT HARVESTED. THE MOST LIKELY CAUSE OF DEGRADATION IS PROLONGED EXPOSURE TO UV LIGHT WHILE THE UNIT WAS STORED AT THE HOSPITAL IN A PYXIS MACHINE AFTER REMOVAL FROM THE SEALED CARTON. THE INSTRUCTIONS FOR USE STATE TO KEEP THE DEVICE AWAY FROM SUNLIGHT. THIS IS TO PROTECT THE DEVICE FROM UV LIGHT. NO MATERIAL OR MANUFACTURING ISSUES THAT COULD CONTRIBUTE TO THIS FAILURE WERE FOUND. THIS IS THE FIRST OCCURRENCE OF THIS NATURE AND WILL BE MONITORED.

    Description of Event or Problem · 1

    PREPARATION FOR A CRYOABLATION PROCEDURE WAS PERFORMED OUTSIDE OF THE PATIENT. DURING THIS PREPARATION, THE BLUE TUBING THAT COVERS THE DISTAL CATHETER WIRES IN THE MAPPING CATHETER CRACKED AND BROKE OFF AS THE PRODUCT WAS PUSHED OUT THROUGH A CRYOABLATION BALLOON CATHETER. NEITHER CATHETER WAS INTRODUCED INTO THE PATIENT. A NEW MAPPING CATHETER AND CRYOABLATION CATHETER WERE USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293502 ACHIEVE MAPPING CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF MEDTRONIC ABLATION FRONTIERS 990063-015 0006379191

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCTIC FRONT ADVANCE CRYOABLATION CATHETER 2AF284