BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX? COLONIC

    MDR report key: 3940214 · Received July 17, 2014

    Report

    Report Number
    3005099803-2014-02521
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MQR
    PMA / PMN Number
    K061877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. (B)(4) FOR THE REPORTED EVENT OF STENT DEPLOYED PREMATURELY. (B)(4) FOR THE REPORTED EVENT OF STENT POSITIONING/PLACEMENT ISSUE. THE COMPLAINANT INDICATED THAT THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS USED IN THE TRANSVERSE COLON DURING A COLONIC DECOMPRESSION AND STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE STENT WAS BEING IMPLANTED TO TREAT A 3 CM MALIGNANT STRICTURE. REPORTEDLY, THE PATIENT¿S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING DEPLOYMENT OF THE STENT, THE WHITE HANDLE DETACHED FROM THE OUTER SHEATH AND THE PHYSICIAN INADVERTENTLY DEPLOYED THE STENT IN THE WRONG LOCATION. THE STENT REMAINS IMPLANTED AND THERE WAS NO ATTEMPT MADE TO REMOVE THE FULLY DEPLOYED STENT. ANOTHER WALLFLEX ENTERAL COLONIC STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418337 WALLFLEX? COLONIC STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC - GALWAY M00565050 16432666

    Patients

    Seq Age Sex Outcome Treatment
    1