BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COYOTE¿ ES

    MDR report key: 2872839 · Received December 13, 2012

    Report

    Report Number
    2134265-2012-07515
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K080982
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THERE WAS A COMPLETE CIRCUMFERENTIAL TEAR OF THE BALLOON. THE INNER SHAFT WAS DETACHED AT THE BOND THAT JOINS THE INNER AND OUTER SHAFT COMPONENTS. THE INNER SHAFT FRACTURE FACE WAS JAGGED AND STRETCHED, WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). MAGNIFIED INSPECTION OF THE INNER SHAFT FRACTURE SURFACE PRESENTED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE SEPARATION. THE PORTION OF THE DEVICE DISTAL TO THE INNER SHAFT SEPARATION - INCLUDING THE INNER SHAFT, DISTAL PORTION OF THE BALLOON, MARKERBANDS AND DISTAL TIP - WERE NOT RETURNED FOR ANALYSIS. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES CONTRIBUTING TO THE DAMAGE. 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 AN ANGIOPLASTY PROCEDURE A BALLOON RUPTURE AND SHAFT FRACTURE OCCURRED. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE MILDLY CALCIFIED, MILDLY TORTUOUS ANTERIOR TIBIAL ARTERY. THE PHYSICIAN ADVANCED A 3MM X 40MM X 146CM COYOTE BALLOON CATHETER TO THE TARGET LESION. UPON THE FIRST INFLATION AT 10ATMS THE BALLOON RUPTURED. WHILE THE PHYSICIAN WAS RETRIEVING THE DEVICE THE SHAFT FRACTURED. THE PHYSICIAN WAS ABLE TO REMOVE THE BALLOON, HOWEVER A PIECE OF THE DISTAL SHAFT REMAINS INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE A BALLOON RUPTURE AND SHAFT FRACTURE OCCURRED. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE MILDLY CALCIFIED, MILDLY TORTUOUS ANTERIOR TIBIAL ARTERY. THE PHYSICIAN ADVANCED A 3MM X 40MM X 146CM COYOTE BALLOON CATHETER TO THE TARGET LESION. UPON THE FIRST INFLATION AT 10ATMS THE BALLOON RUPTURED. WHILE THE PHYSICIAN WAS RETRIEVING THE DEVICE THE SHAFT FRACTURED. THE PHYSICIAN WAS ABLE TO REMOVE THE BALLOON, HOWEVER, A PIECE OF THE DISTAL SHAFT REMAINS INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135304010 15220866

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention