BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY?

    MDR report key: 3073243 · Received April 23, 2013

    Report

    Report Number
    2134265-2013-02709
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE HYPOTUBE WAS BROKEN AT 63 CM FROM THE DISTAL END OF THE STRAIN RELIEF. THE HYPOTUBE WAS FURTHERMORE KINKED THROUGHOUT. NO ISSUES WERE NOTED WITH THE CRIMPED STENT, TIP AND BALLOON OF THE DEVICE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE REMAINDER OF THE SHAFT OF THE DEVICE. 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION CATHETER BREAK OCCURED. THE LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). WHEN THE SYNERGY 2.2516MM STENT WAS TAKEN TO BE INSERTED ON THE NON-BSC GUIDE WIRE, THE CATHETER SHAFT BROKE IN TWO PIECES. THE EVENT OCCURRED OUTSIDE THE GUIDER BEFORE INSERTION. THE PATIENT REMAINED STABLE AND NO COMPLICATION HAS BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION CATHETER BREAK OCCURED. THE LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). WHEN THE SYNERGY 2.2516MM STENT WAS TAKEN TO BE INSERTED ON THE NON-BSC GUIDE WIRE, THE CATHETER SHAFT BROKE IN TWO PIECES. THE EVENT OCCURRED OUTSIDE THE GUIDER BEFORE INSERTION. THE PATIENT REMAINED STABLE AND NO COMPLICATION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174717 SYNERGY? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493919816220 15636673

    Patients

    Seq Age Sex Outcome Treatment
    1 RINATO GUIDE WIRE