BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE? ES

    MDR report key: 3212719 · Received July 9, 2013

    Report

    Report Number
    2134265-2013-04686
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K080982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COYOTE ES CATHETER WAS RECEIVED INSIDE A COYOTE ES SHELF BOX THAT MATCHED THE INFORMATION ON THE DEVICE. THE HYPOTUBE WAS KINKED 35CM FROM THE HYPOTUBE/MID-SHAFT BOND. THE INNER SHAFT WAS BUCKLED ADJACENT TO THE PROXIMAL EDGE OF THE MARKERBAND AND 3MM FROM THE PROXIMAL BALLOON BOND. THE INNER DIAMETER (ID) OF THE INNER SHAFT WAS MEASURED AT BOTH ENDS WITH A CALIBRATED PIN GAUGE SET, WHICH IS WITHIN SPECIFICATION. A .014" GUIDEWIRE WAS LOADED INTO THE TIP BUT COULD NOT BE ADVANCED THROUGH THE INNER SHAFT DAMAGE. THE WIRE WAS NOT STUCK IN THE LUMEN OF THE CATHETER. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, CATHETER ENTRAPMENT ON GUIDE WIRE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS BELOW THE KNEE ARTERY. A 1.5MM X 20MM X 143CM COYOTE¿ ES BALLOON CATHETER WAS ADVANCED AND THE BALLOON WAS INFLATED. AFTER THE FIRST OR SECOND INFLATION, THE SHAFT OF THE BALLOON CATHETER WAS KINKED AND THE TIP OF THE BALLOON WAS DAMAGED. THE DEVICE WAS UNABLE TO BE REMOVED FROM THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, CATHETER ENTRAPMENT ON GUIDE WIRE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS BELOW THE KNEE ARTERY. A 1.5MM X 20MM X 143CM COYOTE ES BALLOON CATHETER WAS ADVANCED AND THE BALLOON WAS INFLATED. AFTER THE FIRST OR SECOND INFLATION, THE SHAFT OF THE BALLOON CATHETER WAS KINKED AND THE TIP OF THE BALLOON WAS DAMAGED. THE DEVICE WAS UNABLE TO BE REMOVED FROM THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312462 COYOTE? ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135152010 16040650

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: CORDIS CHEVALIER FLOPPY| INTRODUCER SHEATH: MEDIKIT PARENTPLUS4.5F| INFLATION DEVICE: SHEEMAN