BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE¿ ES

    MDR report key: 5993730 · Received October 3, 2016

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    Report

    Report Number
    2134265-2016-08719
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Date of Event
    September 8, 2016
    Report Date
    September 8, 2016
    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 MFR: RETURNED PRODUCT CONSISTED OF A COYOTE ES BALLOON CATHETER. THE BALLOON WAS LOOSELY FOLDED WITH CONTRAST IN THE BALLOON AND INFLATION LUMEN. MICROSCOPIC INSPECTION REVEALED A PINHOLE IN THE BALLOON MATERIAL, LOCATED ON THE DISTAL EDGE OF THE DISTAL MARKERBAND. INSPECTION OF THE REMAINDER OF THE DEVICE REVEALED DAMAGED TO THE TIP OF THE DEVICE. THERE IS NO INDICATION THE DEVICE WAS INFLATED OVER ITS RATED BURST PRESSURE (RBP). 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 BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL INTO THE VESSEL BELOW THE KNEE. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ANTERIOR TIBIAL ARTERY. AFTER A NON-BSC INTRODUCER SHEATH WAS PLACED, A NON-BSC GUIDE WIRE CROSSED THE LESION. THE PHYSICIAN REPLACED THE WIRE USING ANOTHER NON-BSC GUIDEWIRE. THEN A 2.5MMX40MMX146CM COYOTE¿ ES BALLOON CATHETER WAS ADVANCED FOR DILATION. THERE WAS NO VISUAL ISSUE NOTED ON THE DEVICE PRIOR TO USE. HOWEVER, DURING THE FIRST INFLATION AT 5 ATMOSPHERES, THE BALLOON RUPTURED AFTER BEING INFLATED FOR 10 SECONDS. FLUOROSCOPY WAS PERFORMED AND A CONTRAST AGENT LEAKAGE WAS CONFIRMED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND WHEN THE PHYSICIAN CHECKED THE DEVICE OUTSIDE THE PATIENT, IT WAS NOTED THAT THERE WAS A LONGITUDINAL CRACK ON THE BALLOON. 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 BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL INTO THE VESSEL BELOW THE KNEE. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ANTERIOR TIBIAL ARTERY. AFTER A NON-BSC INTRODUCER SHEATH WAS PLACED, A NON-BSC GUIDE WIRE CROSSED THE LESION. THE PHYSICIAN REPLACED THE WIRE USING ANOTHER NON-BSC GUIDEWIRE. THEN A 2.5MMX40MMX146CM COYOTE¿ ES BALLOON CATHETER WAS ADVANCED FOR DILATION. THERE WAS NO VISUAL ISSUE NOTED ON THE DEVICE PRIOR TO USE. HOWEVER, DURING THE FIRST INFLATION AT 5 ATMOSPHERES, THE BALLOON RUPTURED AFTER BEING INFLATED FOR 10 SECONDS. FLUOROSCOPY WAS PERFORMED AND A CONTRAST AGENT LEAKAGE WAS CONFIRMED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND WHEN THE PHYSICIAN CHECKED THE DEVICE OUTSIDE THE PATIENT, IT WAS NOTED THAT THERE WAS A LONGITUDINAL CRACK ON THE BALLOON. 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
    645896 COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135254010 17874801

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: AGOSAL| INTRODUCER SHEATH:SHEATHLESS PV55