BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3002375 · Received March 13, 2013

    Report

    Report Number
    2134265-2013-01662
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: AN INITIAL VISUAL EXAMINATION OF THE RETURNED DEVICE IDENTIFIED AN IRREGULARLY SHAPED REDDISH/BROWN PARTICLE LESS THAN 1MM IN DIAMETER ATTACHED TO THE SURFACE OF THE TIP SECTION OF THE DEVICE. A MICROSCOPIC IMAGE WAS TAKEN OF THE FOREIGN MATERIAL AND DURING THIS PROCESS THE MATERIAL DETACHED FROM THE TIP AND COULD NOT BE RETRIEVED. A RESIDUE OF THIS FOREIGN MATERIAL REMAINED ON THE SURFACE OF THE TIP. THE TIP WAS SENT TO AN EXTERNAL LABORATORY FOR FURTHER ANALYSIS. A LIGHT MICROSCOPY AND SCANNING ELECTRON MICROSCOPY/ENERGY-DISPERSIVE X-RAY ANALYSIS WAS PERFORMED. IT DETERMINED THAT THE FOREIGN MATERIAL WAS IODINE BASED AND CONTAINS SOME BLOOD CELLS. THE COLOUR AND COMPOSITION OF THE FOREIGN MATERIAL IS CONSISTENT WITH POVIDINE IODINE. THIS IS COMMONLY USED IN A CLINICAL SETTING AS A TOPICAL ANTISEPTIC SOLUTION. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF THE DEVICE FOR PERCUTANEOUS CORONARY INTERVENTION, A FOREIGN MATERIAL WAS NOTICED. THE 100% STENOSED AND CALCIFIED LESION WAS LOCATED IN THE SEVERELY TORTUOUS MID RIGHT CORONARY ARTERY. A 3.00X38MM PROMUS ELEMENT PLUS STENT WAS REMOVED FROM THE HOOP AND THE MANDREL FROM THE DEVICE WAS ALSO REMOVED. WHEN THE DEVICE WAS ATTEMPTED TO BE ADVANCE ON THE GUIDE WIRE, A FOREIGN MATERIAL LIKE A "HAIRBALL OR DUST" WAS NOTICED AT THE TIP OF THE DEVICE. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED USING A PROMUS ELEMENT 3.5X38MM . NO PATIENT COMPLICATIONS WERE NOTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF THE DEVICE FOR PERCUTANEOUS CORONARY INTERVENTION, A FOREIGN MATERIAL WAS NOTICED. THE 100% STENOSED AND CALCIFIED LESION WAS LOCATED IN THE SEVERELY TORTUOUS MID RIGHT CORONARY ARTERY. A 3.00X38MM PROMUS ELEMENT PLUS STENT WAS REMOVED FROM THE HOOP AND THE MANDREL FROM THE DEVICE WAS ALSO REMOVED. WHEN THE DEVICE WAS ATTEMPTED TO BE ADVANCE ON THE GUIDE WIRE, A FOREIGN MATERIAL LIKE A "HAIRBALL OR DUST" WAS NOTICED AT THE TIP OF THE DEVICE. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED USING A PROMUS ELEMENT 3.5X38MM . NO PATIENT COMPLICATIONS WERE NOTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106087 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918438300 15529113

    Patients

    Seq Age Sex Outcome Treatment
    1