BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE¿ ES

    MDR report key: 2943116 · Received February 5, 2013

    Report

    Report Number
    2134265-2013-00292
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 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 - THERE WAS BLOOD IN THE INFLATION LUMEN. THE BALLOON WAS DEFLATED, AS-RECEIVED. MAGNIFIED INSPECTION REVEALED A TEAR IN THE OUTER SHAFT 53MM FROM THE PROXIMAL BALLOON BOND. THE LENGTH OF THE TEAR WAS 5MM. FUNCTIONAL TESTING CONFIRMED THAT THE TEAR IN THE OUTER SHAFT PREVENTED BALLOON INFLATION. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS PERIPHERAL INTERVENTION, A BALLOON RUPTURE OCCURRED. THE 99% STENOSED AND CALCIFIED TARGET LESION WAS LOCATED BELOW THE KNEE. THE 1.5X20MM 142CM COYOTE BALLOON WAS SUCCESSFULLY INFLATED ONCE TO 12ATM, UPON THE SECOND INFLATION TO 12ATM THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS PERIPHERAL INTERVENTION, A BALLOON RUPTURE OCCURRED. THE 99% STENOSED AND CALCIFIED TARGET LESION WAS LOCATED BELOW THE KNEE. THE 1.5X20MM 142CM COYOTE BALLOON WAS SUCCESSFULLY INFLATED ONCE TO 12ATM, UPON THE SECOND INFLATION TO 12ATM THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49363 COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939134152010 15393920

    Patients

    Seq Age Sex Outcome Treatment
    1