BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE¿ ES

    MDR report key: 2943847 · Received February 5, 2013

    Report

    Report Number
    2134265-2013-00272
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 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

    DEVICE EVALUATED BY MANUFACTURER: THE COYOTE ES CATHETER WAS RECEIVED FOR ANALYSIS. THERE WAS BLOOD IN THE BALLOON AND INFLATION LUMEN. MAGNIFIED INSPECTION REVEALED NO DAMAGE. WHEN POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER, A STREAM OF WATER EMITTED FROM A PINHOLE ALIGNED WITH THE DISTAL EDGE OF THE DISTAL MARKERBAND. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2013-00271. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, BALLOON RUPTURE OCCURRED. ACCESS WAS OBTAINED VIA LEFT FEMORAL ARTERY. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT POSTERIOR TIBIAL ARTERY. A 2.5MM X 20MM X 143CM COYOTE ES OTW WAS USED FOR DILATATION OF THE LESION. UPON THE FIRST INFLATION AT 3 ATM, THE BALLOON RUPTURED. ANOTHER 2.5MM X 20MM X 143CM COYOTE ES OTW WAS THEN USED FOR DILATATION OF THE LESION. UPON THE FIRST INFLATION AT 4 ATM, THE BALLOON RUPTURED. BOTH DEVICES WERE REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A NON-BSC PRODUCT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT STATUS POST PROCEDURE WAS LISTED AS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2013-00271. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, BALLOON RUPTURE OCCURRED. ACCESS WAS OBTAINED VIA LEFT FEMORAL ARTERY. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT POSTERIOR TIBIAL ARTERY. A 2.5 MM X 20 MM X 143 CM COYOTE ES OTW WAS USED FOR DILATATION OF THE LESION. UPON THE FIRST INFLATION AT 3 ATM, THE BALLOON RUPTURED. ANOTHER 2.5 MM X 20 MM X 143 CM COYOTE ES OTW WAS THEN USED FOR DILATATION OF THE LESION. UPON THE FIRST INFLATION AT 4 ATM, THE BALLOON RUPTURED. BOTH DEVICES WERE REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A NON-BSC PRODUCT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT STATUS POST PROCEDURE WAS LISTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49173 COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939134252010 15353061

    Patients

    Seq Age Sex Outcome Treatment
    1 INFLATION DEVICE: JMS| GUIDING WIRE: CRUISE (ST. JUDE MEDICAL)| INTRODUCER SHEATH: 6F BRITE TIP (J&J)