BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2904278 · Received January 9, 2013

    Report

    Report Number
    2134265-2012-08307
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 12, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED A BREAK AT THE MIDSHAFT 108.5CM DISTAL FROM THE STRAIN RELIEF. THE DISTAL SECTION OF THE BREAK INCLUDING THE EXCHANGE PORT, INNER AND OUTER LUMENS, BALLOON AND TIP SECTIONS WERE NOT RETURNED FOR ANALYSIS. A MICROSCOPIC EXAMINATION OF THE BREAK SITE IDENTIFIED THAT THE EXTRUSION WAS STRETCHED, CONSISTENT WITH EXCESSIVE TENSILE FORCE HAVING BEEN APPLIED TO THE SHAFT. THE MIDSHAFT BOND SITE WAS FULLY INTACT. A VISUAL AND MICROSCOPIC EXAMINATION ALSO IDENTIFIED KINKS ALONG THE ENTIRE LENGTH OF THE HYPOTUBE. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. 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 PRIOR TO CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE CATHETER SEPARATED. THE LESION BEING TREATED IS UNKNOWN. WHEN THE PHYSICIAN REMOVED THE STYLET WIRE THE WHOLE CATHETER SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO CORONARY ARTERY STENTING TREATMENT PROCEDURE THE CATHETER SEPARATED. THE LESION BEING TREATED IS UNKNOWN. WHEN THE PHYSICIAN REMOVED THE STYLET WIRE THE WHOLE CATHETER SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12060 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911416300 15449846

    Patients

    Seq Age Sex Outcome Treatment
    1