BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE¿ ES

    MDR report key: 2991466 · Received March 6, 2013

    Report

    Report Number
    2134265-2013-01256
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 7, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A FAILURE ANALYSIS OF THE DEVICE COULD NOT BE COMPLETED. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS PERIPHERAL INTERVENTION (PPI) TREATMENT, A BALLOON RUPTURE OCCURRED THE VASCULAR ACCESS WAS OBTAINED VIA RIGHT FEMORAL ARTERY WITH A 6F 45CM NON-BSC SHEATH. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN PLACED A NON-BSC GUIDE WIRE ACROSS THE LESION. THE 1.5MM X 20MM COYOTE BALLOON CATHETER WAS THEN SELECTED AND ADVANCED OVER THE GUIDE WIRE TO THE LESION. THE PHYSICIAN EXPERIENCED DIFFICULTIES CROSSING THE LESION WITH THE BALLOON CATHETER. THE BALLOON WAS INFLATED TWICE AT 6ATMS AT THE PROXIMAL OF THE LESION. DURING THE THIRD INFLATION THE BALLOON RUPTURED AT 6ATMS. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH 2.0MM × 2MM COYOTE BALLOON CATHETER INFLATED THREE TIMES AT 6ATM. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95828 COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939134152010 15417015

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: 014 CRUISE(ST. JUDE MEDICAL)| ASTATO XS9-12 (ST. JUDE MEDICAL)| GUIDE CATHETER: 2.1F 100CM TORNUS (ASAHI INTECC)