BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRELLIS 8 80X15

    MDR report key: 2220053 · Received August 12, 2011

    Report

    Report Number
    2953189-2011-00044
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 27, 2011
    Manufacturer
    COVIDIEN
    Product Code
    KRA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A TRELLIS. THE CUSTOMER THE TRELLIS 8 MOTOR STOPPED MID-PROCEDURE. THE TRELLIS WAS RUNNING WITH NO TPA IN THE TREATMENT AREA IN HOPES TO CLEAR THE AREA OF CLOT WITH THE ACTION OF THE WIRE. THE MOTOR WORKED FINE FOR THE FEW MINUTES, AND THEN THE MOTOR BEGAN TO SOUND UNUSUAL. THE MOTOR STOPPED WORKING COMPLETELY. AN ATTEMPT WAS MADE TO REMOVE THE SINUSOIDAL WAVE WIRE FROM THE TRELLIS CATHETER, BUT IT WAS UNSUCCESSFUL. CUSTOMER STATED THE PROCESS OF REMOVING THE GUIDEWIRE, THE INFLATION/DEFLATION CHANNEL OF THE CATHETER BECAME BLOCKED SOMEHOW. CUSTOMER WAS UNABLE TO TAKE THE PROXIMAL BALLOON DOWN. CUSTOMER WAS FORCED TO PUNCTURE THE PATIENT IN THE GROIN-REGION IN ORDER TO SYRINGE ASPIRATE THE PROXIMAL BALLOON. AFTER DEFLATING THE BALLOON, THE TRELLIS CATHETER WAS REMOVED FROM THE PATIENT WITH THE WIRE INTACT. ONCE REMOVED FROM THE PATIENT, THE POWER SWITCH ON THE TRELLIS DRIVE UNIT WAS ACCIDENTLY PRESSED ON. THE TRELLIS WIRE (NOW HALF-REMOVED FROM THE CATHETER) BEGAN TO OSCILLATE. OVERALL, THE MAJORITY OF THE GUIDEWIRE INSIDE THE CATHETER WAS TWISTED UPON ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRELLIS 8 80X15 TRELLIS KRA COVIDIEN BVT808015 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention