BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE¿

    MDR report key: 2792337 · Received October 16, 2012

    Report

    Report Number
    2134265-2012-06575
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 20, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K111295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.:THERE WAS SOLIDIFIED CONTRAST AND BLOOD IN THE INFLATION LUMEN AND THE WIRE LUMEN. THE DISTAL TIP WAS DAMAGED. THE PROXIMAL PORTION OF THE BALLOON WAS BUNCHED-UP. THE INNER SHAFT WAS BUCKLED 17-22 CM FROM THE DISTAL TIP. THE GUIDEWIRE WAS PROTRUDING 3 MM FROM TIP. GENTLY PULLING ON THE WIRE, THE WIRE WAS REMOVED FROM THE WIRE LUMEN. THE DISTAL PORTION OF THE GUIDEWIRE WAS ELONGATED, UNRAVELED AND BROKEN. THE PROXIMAL PORTION OF THE GUIDEWIRE WAS NOT RETURNED. DUE TO THE RETURNED CONDITION OF THE GUIDEWIRE, THE OUTER DIAMETER COULD NOT BE MEASURED. THE INNER DIAMETER (ID) OF THE INNER SHAFT WAS MEASURED AT BOTH ENDS AND FOUND TO BE WITHIN SPECIFICATION. FUNCTIONAL TESTING WAS PERFORMED BY LOADING A .014" GUIDEWIRE INTO THE TIP AND ADVANCING THROUGH THE INNER SHAFT OF THE CATHETER ENCOUNTERING RESISTANCE IN THE LOCATION OF THE INNER SHAFT DAMAGE. THE WIRE WAS NOT STUCK IN THE LUMEN OF THE CATHETER, AS REPORTED, BUT THE DAMAGED INNER SHAFT AND CONFIRMED DIFFICULTY LOADING THE WIRE THROUGH THE CATHETER ARE CONSISTENT WITH THE REPORTED DIFFICULTY. 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 PROCEDURE, A BALLOON CATHETER WAS ENTRAPPED ON A GUIDE WIRE. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR TIBIAL ARTERY. DURING ADVANCING THE 3.0 X 220MM COYOTE MR BALLOON CATHETER THROUGH A 4FR NON BSC INTRODUCER SHEATH, AND OVER A NON BSC GUIDE WIRE, THE DEVICE KINKED AT THE GUIDE WIRE EXIT PORT AND BECAME ENTRAPPED ON THE GUIDE WIRE. THE DEVICE AND GUIDE WIRE WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON CATHETER WAS ENTRAPPED ON A GUIDE WIRE. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR TIBIAL ARTERY. DURING ADVANCING THE 3.0 X 220MM COYOTE MR BALLOON CATHETER THROUGH A 4FR NON BSC INTRODUCER SHEATH, AND OVER A NON BSC GUIDE WIRE, THE DEVICE KINKED AT THE GUIDE WIRE EXIT PORT AND BECAME ENTRAPPED ON THE GUIDE WIRE. THE DEVICE AND GUIDE WIRE WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COYOTE¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939185302210 15401393

    Patients

    Seq Age Sex Outcome Treatment
    1 ZEON 4FR: INTRODUCER SHEATH| AGURU HC: GUIDE WIRE