BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE? ES

    MDR report key: 3132334 · Received May 29, 2013

    Report

    Report Number
    2134265-2013-03660
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K080982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COYOTE ES CATHETER WAS RECEIVED WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. THE TIP WAS DAMAGED. THE HYPOTUBE WAS SEPARATED IN TWO (2) PLACES, 80CM FROM THE STRAIN RELIEF AND 20CM FROM THE GUIDEWIRE EXIT NOTCH. THE SHEATH THAT ENCASES THE HYPOTUBE WAS INTACT AT THE LOCATION OF THE SECOND FRACTURE (20CM). THE HYPOTUBE FRACTURE SURFACES WERE OVALED, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. THE INNER DIAMETER (ID) OF THE WIRE LUMEN WAS MEASURED AT BOTH ENDS WITH A CALIBRATED PIN GAUGE SET AND WAS WITHIN SPECIFICATION. A .014" GUIDEWIRE WAS LOADED INTO THE TIP AND COMPLETELY ADVANCED THROUGH THE WIRE LUMEN WITHOUT ENCOUNTERING ANY UNUSUAL RESISTANCE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PERCUTANEOUS PERIPHERAL INTERVENTION, THE BALLOON CATHETER WAS STUCK ON THE GUIDE WIRE. A NON-BSC GUIDE WIRE WAS POSITIONED IN THE UNSPECIFIED TARGET LESION. AN ATTEMPT WAS MADE TO ADVANCE THE 1.5MM X 20MM X 143CM COYOTE ES BALLOON CATHETER INTO THE SHEATH AROUND THE AORTIC BIFURCATION, HOWEVER, THE BALLOON CATHETER WAS STUCK ON WIRE. THE PHYSICIAN MOVED THE CATHETER FORWARD AND BACKWARDS BUT IT WAS STILL STUCK. THE BALLOON CATHETER AND THE WIRE WAS THEN REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PERCUTANEOUS PERIPHERAL INTERVENTION, THE BALLOON CATHETER WAS STUCK ON THE GUIDE WIRE. A NON-BSC GUIDE WIRE WAS POSITIONED IN THE UNSPECIFIED TARGET LESION. AN ATTEMPT WAS MADE TO ADVANCE THE 1.5MM X 20MM X 143CM COYOTE ES BALLOON CATHETER INTO THE SHEATH AROUND THE AORTIC BIFURCATION, HOWEVER, THE BALLOON CATHETER WAS STUCK ON WIRE. THE PHYSICIAN MOVED THE CATHETER FORWARD AND BACKWARDS BUT IT WAS STILL STUCK. THE BALLOON CATHETER AND THE WIRE WAS THEN REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236616 COYOTE? ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135152010 15950592

    Patients

    Seq Age Sex Outcome Treatment
    1