BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE¿ ES

    MDR report key: 2618242 · Received June 15, 2012

    Report

    Report Number
    2134265-2012-03651
    Event Type
    Malfunction
    Date Received
    June 15, 2012
    Date of Event
    May 28, 2012
    Report Date
    May 28, 2012
    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

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COYOTE ES CATHETER WAS RECEIVED WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. MAGNIFIED INSPECTION REVEALED A LONGITUDINAL TEAR IN THE BALLOON WALL ON THE DISTAL END OF THE BALLOON. THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. 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 A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS GAINED VIA THE RIGHT FEMORAL ARTERY. THE 100% STENOSED CHRONIC TOTAL OCCLUDED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS RIGHT ANTERIOR TIBIAL ARTERY. A .014" NON BSC GUIDE WIRE AND A .014" NON BSC MICRO CATHETER CROSSED THE LESION. A COYOTE ES MR 2.5MM X 20MM X 144CM BALLOON CATHETER WAS INFLATED FOR 5 SECONDS AND RUPTURED AT 14 ATM. THE PROCEDURE WAS COMPLETED WITH A STERLING MR 3.0MM X 40MM. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS GAINED VIA THE RIGHT FEMORAL ARTERY. THE 100% STENOSED CHRONIC TOTAL OCCLUDED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS RIGHT ANTERIOR TIBIAL ARTERY. A .014" NON BSC GUIDE WIRE AND A .014" NON BSC MICRO CATHETER CROSSED THE LESION. A COYOTE ES MR 2.5MM X 20MM X 144CM BALLOON CATHETER WAS INFLATED FOR 5 SECONDS AND RUPTURED AT 14 ATM. THE PROCEDURE WAS COMPLETED WITH A STERLING MR 3.0MM X 40MM. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135252010 13383429

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: 014 ASTATO XS| MICRO CATHETER: 014 PROMINENT