BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE¿

    MDR report key: 2962283 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00722
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 21, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K111295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE TIP, DISTAL MARKERBAND AND DISTAL PORTION OF THE BALLOON SEPARATION WERE NOT RETURNED FOR ANALYSIS. THERE WAS A CIRCUMFERENTIAL BALLOON TEAR 5MM FROM THE PROXIMAL BALLOON BOND. THE INNER SHAFT WAS STRETCHED, KINKED AND SEPARATED DISTALLY FROM THE BALLOON SEPARATION. THE FRACTURE FACE WAS JAGGED AND STRETCHED, WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD. MAGNIFIED INSPECTION OF THE FRACTURE SURFACE PRESENTED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE SEPARATION. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES CONTRIBUTING TO THE REPORTED EVENT AND CONFIRMED DAMAGE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2013-00748 AND MDR# 2134265-2013-00684. IT WAS REPORTED THAT DURING A LOWER EXTREMITY INTERVENTIONAL PROCEDURE, THE BALLOON DETACHED FROM THE CATHETER. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. THE 2.0 X 100 MM COYOTE BALLOON CATHETER WAS BEING REMOVED FROM THE PATIENT, WHEN IT WAS ENTRAPPED ON THE .014 LUGE GUIDE WIRE. THE GUIDE WIRE AND BALLOON CATHETER WERE REMOVED TOGETHER. A 2.0 X 220 MM COYOTE BALLOON WAS BEING REMOVED FROM THE HOOP WHEN THE PHYSICIAN MET INCREASED RESISTANCE, UNTIL THE BALLOON BEGAN TO STRIP OFF THE CATHETER OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#2134265-2013-00748 AND MDR# 2134265-2013-00684. IT WAS REPORTED THAT DURING A LOWER EXTREMITY INTERVENTIONAL PROCEDURE, THE BALLOON DETACHED FROM THE CATHETER. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. THE 2.0 X 100MM COYOTE BALLOON CATHETER WAS BEING REMOVED FROM THE PATIENT, WHEN IT WAS ENTRAPPED ON THE .014 LUGE GUIDE WIRE. THE GUIDE WIRE AND BALLOON CATHETER WERE REMOVED TOGETHER. A 2.0 X 220MM COYOTE BALLOON WAS BEING REMOVED FROM THE HOOP WHEN THE PHYSICIAN MET INCREASED RESISTANCE, UNTIL THE BALLOON BEGAN TO STRIP OFF THE CATHETER OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65002 COYOTE¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939186202210 15711412

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR