BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY? II

    MDR report key: 3761193 · Received April 21, 2014

    Report

    Report Number
    2134265-2014-02123
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 27, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    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.: A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE STENT WAS BADLY STRETCHED AND DISTORTED. THE STENT STRETCHED 10MM PAST THE DISTAL TIP. IT WAS ALSO NOTED THAT THE HYPOTUBE WAS KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. 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 WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT MOVED ON BALLOON OCCURRED. DURING PREPARATION, THE NURSE SLIDES HER RIGHT HAND OVER THE 3.50 X 32 SYNERGY¿ II DRUG-ELUTING STENT CATHETER VERY SMOOTHLY HOWEVER, SHE SAW THAT THE STENT HAD MOVED OVER THE BALLOON AND TOWARDS THE TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT MOVED ON BALLOON OCCURRED. DURING PREPARATION, THE NURSE SLIDES HER RIGHT HAND OVER THE 3.50 X 32 SYNERGY II DRUG-ELUTING STENT CATHETER VERY SMOOTHLY HOWEVER, SHE SAW THAT THE STENT HAD MOVED OVER THE BALLOON AND TOWARDS THE TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240860 SYNERGY? II CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493926232350 16509998

    Patients

    Seq Age Sex Outcome Treatment
    1