BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE¿ ES

    MDR report key: 2972842 · Received February 21, 2013

    Report

    Report Number
    2134265-2013-00990
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 30, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). THE COMPLAINT DEVICE WAS NOT RECEIVED 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

    SAME CASE AS MDR ID# 2134265-2013-00991. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. USING BOTH A LEFT BRACHIAL AND RIGHT FEMORAL ARTERY APPROACH, THE 100% STENOSED LESION WAS LOCATED IN A SEVERELY CALCIFIED, MODERATELY TORTUOUS COMMON TO EXTERNAL ILIAC ARTERY (BOTH SIDES). THE 1.5MM X 20MM X 143CM COYOTE ES BALLOON CATHETER WAS BEING USED FOR PRE-DILATATION. THE BALLOON WAS INITIALLY INFLATED TO 10ATMS AND RUPTURED AT 14ATMS UPON 2ND INFLATION. THEY USED ANOTHER 1.5MM X 20MM X 143CM COYOTE ES BALLOON CATHETER AND DILATED THE LESION AT 14ATM WITH NO ISSUE. AFTER THIS DILATATION, THEY SWITCHED TO NON-BSC BALLOON, TO DILATE AGAIN, BUT THE NON-BSC BALLOON RUPTURED. FOLLOWING THIS, THEY USED A 4.0MM X 40MM MUSTANG BALLOON CATHETER AND INFLATED IT FIRST TO 12ATMS, THEN TO 18ATMS AND IT RUPTURED AT 22ATM UPON 3RD INFLATION. THE RUPTURED BALLOONS WERE REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76002 COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135152010 15194493

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: CHEVALIER (J&J)| BALLOON CATHETER: 4MM BALLOON (JACKAL: KANEKA)| SHEATH: 6FR 90CM PARENT : MEDIKIT| INFLATION DEVICE: EVEREST (MEDTRONIC)| GUIDEWIRE: RADIFORCUS (TERUMO)| GUDIEWIRE: TREASURE (SJM)| SHEATH: 6FR 25CM SHEATH: TERUMO