BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE? PUSH

    MDR report key: 3813188 · Received May 15, 2014

    Report

    Report Number
    2134265-2014-02627
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF AN EMERGE BALLOON CATHETER WITH A CARRIER TUBE (HOOP). THERE WAS CONTRAST IN THE INFLATION LUMEN AND BALLOON. THE BALLOON WAS LOOSELY FOLDED. INSPECTION OF THE DEVICE PRESENTED NO DAMAGE OR IRREGULARITIES. THE INNER DIAMETER (ID) OF THE CATHETER WAS MEASURED AT BOTH ENDS AND WAS WITHIN SPECIFICATIONS. THE GUIDEWIRE USED IN THE PROCEDURE WAS NOT RECEIVED WITH THIS DEVICE. A .014¿ KINETIX GUIDEWIRE WAS USED FOR FUNCTIONAL TESTING. THE OUTER DIAMETER (OD) OF THE KINETIX GUIDEWIRE WAS MEASURED AND WITHIN SPECIFICATIONS. FUNCTIONAL TESTING WAS PERFORMED BY LOADING THE GUIDEWIRE INTO THE TIP AND ADVANCING THROUGH THE INNER SHAFT OF THE CATHETER. THE GUIDEWIRE WAS ADVANCED THROUGH THE ENTIRE LENGTH OF THE GUIDEWIRE LUMEN WITH NO RESISTANCE. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE REPORTED EVENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED CIRCUMFLEX ARTERY. A 1.20MM X 8MM EMERGE PUSH CATHETER BALLOON WAS SELECTED FOR USE AND ADVANCED TO PREDILATE THE LESION. UPON ATTEMPTING TO REMOVE THE DEVICE, THE CATHETER WAS REMOVED FROM THE PATIENT WITH THE NON BSC GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH A NEW WIRE AND A DIFFERENT BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED CIRCUMFLEX ARTERY. A 1.20MM X 8MM EMERGE PUSH CATHETER BALLOON WAS SELECTED FOR USE AND ADVANCED TO PREDILATE THE LESION. UPON ATTEMPTING TO REMOVE THE DEVICE, THE CATHETER WAS REMOVED FROM THE PATIENT WITH THE NON BSC GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH A NEW WIRE AND A DIFFERENT BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290927 EMERGE? PUSH CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493919408120 16539213

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR ASHAHI