BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE¿

    MDR report key: 6013497 · Received October 10, 2016

    Report

    Report Number
    2134265-2016-08815
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Date of Event
    September 13, 2016
    Report Date
    September 13, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K111295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF A COYOTE BALLOON CATHETER. THE BALLOON WAS LOOSELY FOLDED WITH BLOOD IN THE BALLOON, LUMEN AND HUB. MICROSCOPIC INSPECTION REVEALED A PINHOLE IN THE BALLOON MATERIAL, 29MM DISTAL OF THE PROXIMAL MARKERBAND. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.5MMX80MMX150CM, OTW COYOTE BALLOON CATHETER WAS SELECTED FOR DILATATION. DURING PREPARATION, THE BALLOON COVERING WAS PINCHED THEN TWISTED HOWEVER THE COVERING WAS HARD TO REMOVE. THE BALLOON CATHETER WAS THEN ADVANCED FOR DILATATION; HOWEVER UPON INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.5MMX80MMX150CM, OTW COYOTE¿ BALLOON CATHETER WAS SELECTED FOR DILATATION. DURING PREPARATION, THE BALLOON COVERING WAS PINCHED THEN TWISTED HOWEVER THE COVERING WAS HARD TO REMOVE. THE BALLOON CATHETER WAS THEN ADVANCED FOR DILATATION; HOWEVER UPON INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665319 COYOTE¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939186250810 19333077

    Patients

    Seq Age Sex Outcome Treatment
    1