BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE¿

    MDR report key: 2802919 · Received October 24, 2012

    Report

    Report Number
    2134265-2012-06420
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    August 13, 2012
    Report Date
    September 27, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K111295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS WITH DRIED CONTRAST IN THE BALLOON AND INFLATION LUMEN. THE BALLOON WAS LOOSELY FOLDED AND THE INNER AND OUTER SHAFT WAS SEPARATED 152.5 CM AND 151 CM FROM THE TIP. THE FRACTURE FACES WERE JAGGED AND STRETCHED, WHICH SUGGESTS THAT THE SEPARATIONS MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). MAGNIFIED INSPECTION OF THE FRACTURE SURFACES PRESENTED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE SEPARATIONS. THERE WAS A KINK 1.5 CM FROM THE OUTER SHAFT FRACTURE FACE. THE PROXIMAL PORTION OF THE CATHETER (INCLUDING THE HUB/MANIFOLD) WAS NOT RETURNED FOR ANALYSIS. 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

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2012. IT WAS REPORTED THAT DURING AN ANGIOPLASTY TREATMENT PROCEDURE, A POOR BALLOON REWRAP OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY. THIS 4.0 MM X 220 MM X 150 CM COYOTE OTW BALLOON CATHETER WAS SELECTED AND FOLLOWING THE PROCEDURE, THE BALLOON FAILED TO RE-FOLD WHILE INSIDE THE PATIENT. THE COYOTE BALLOON WAS REMOVED FROM THE PATIENT INTACT. THE PROCEDURE WAS CONTINUED WITH ANOTHER OF THE SAME COYOTE BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COYOTE¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939186402210 14704718

    Patients

    Seq Age Sex Outcome Treatment
    1