BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE? ES

    MDR report key: 4150791 · Received October 8, 2014

    Report

    Report Number
    2134265-2014-05966
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    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: RETURNED PRODUCT CONSISTED OF A COYOTE ES BALLOON CATHETER WITH A STOPCOCK ATTACHED TO THE HUB. THERE WAS CONTRAST AND BLOOD IN THE INFLATION LUMEN AND BALLOON AND THERE WAS BLOOD IN THE MANIFOLD. THE BALLOON WAS LOOSELY FOLDED WITH THE BALLOON FOLDS PRESENT. MICROSCOPIC EXAMINATION REVEALED A HOLE IN THE INNER SHAFT 1MM PROXIMAL OF THE DISTAL MARKERBAND. MICROSCOPIC EXAMINATION PRESENTED NO DAMAGE OR IRREGULARITIES IN THE BALLOON. MICROSCOPIC EXAMINATION PRESENTED NO DAMAGE OR IRREGULARITIES IN THE MARKER. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. 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. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. FOLLOWING THE INSERTION OF A NON-BSC INTRODUCER SHEATH AND THE ADVANCEMENT OF A NON-BSC GUIDE WIRE, A 4MM X 40MM X 146CM COYOTE¿ ES BALLOON CATHETER WAS SELECTED FOR USE TO PREDILATE THE LESION. UPON THE FIRST INFLATION, THE BALLOON RUPTURED AT 4 ATMOSPHERES FOR A DURATION OF 1 SECOND. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. FOLLOWING THE INSERTION OF A NON-BSC INTRODUCER SHEATH AND THE ADVANCEMENT OF A NON-BSC GUIDE WIRE, A 4MM X 40MM X 146CM COYOTE¿ ES BALLOON CATHETER WAS SELECTED FOR USE TO PREDILATE THE LESION. UPON THE FIRST INFLATION, THE BALLOON RUPTURED AT 4 ATMOSPHERES FOR A DURATION OF 1 SECOND. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632925 COYOTE? ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135404010 17023388

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: CRUISE| INTRODUCER SHEATH: DESTINATION| INFLATION DEVICE: EVEREST