BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX? COLONIC

    MDR report key: 4093772 · Received September 16, 2014

    Report

    Report Number
    3005099803-2014-03130
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 23, 2014
    Report Date
    August 26, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MQR
    PMA / PMN Number
    K061877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. ''PERFORATION'' AND ''PAIN (E.G. DISCOMFORT, FOREIGN BODY SENSATION)'' ARE LISTED IN THE DFU FOR THIS PRODUCT AS A POTENTIAL POST STENT PLACEMENT COMPLICATION RELATED TO THE USE OF THIS DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS IMPLANTED IN THE SIGMOID COLON DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2014. THE STENT WAS IMPLANTED TO RELIEVE AN ILEUS OF THE COLON. ACCORDING TO THE COMPLAINANT, THE PATIENT'S ANATOMY WAS TORTUOUS. THERE WERE NO ISSUES DURING STENT PLACEMENT. REPORTEDLY, THE PATIENT COMPLAINED OF ABDOMINAL PAIN POST-PROCEDURE. ON (B)(6) 2014, THE PATIENT COMPLAINED AGAIN OF ABDOMINAL PAIN AND IT WAS REPORTED THAT A PERFORATION WAS OBSERVED IN THE SIGMOID COLON. THE PATIENT UNDERWENT AN EMERGENCY SURGERY AND A STOMA WAS MADE. IN THE PHYSICIAN'S ASSESSMENT, THE SURGERY WAS DUE TO THE PERFORATION WHICH WAS POSSIBLY CAUSED BY THE NON-BSC GUIDEWIRE. HOWEVER, BSC WAS UNABLE TO OBTAIN CONFIRMATION OF THE PHYSICIAN'S ASSESSMENT OF THE RELATIONSHIP BETWEEN THE STENT AND THE PERFORATION. ON (B)(6) 2014, IT WAS REPORTED THAT THE PATIENT'S CONDITION WAS NOT GOOD. HOWEVER, ADDITIONAL FOLLOW UP ON (B)(6) 2014 NOTED THAT THE PATIENT'S CONDITION IS NOW STABLE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2014. THE STENT WAS REMOVED DURING THE EMERGENCY SURGERY ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS IMPLANTED IN THE SIGMOID COLON DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2014. THE STENT WAS IMPLANTED TO RELIEVE AN ILEUS OF THE COLON. ACCORDING TO THE COMPLAINANT, THE PATIENT¿S ANATOMY WAS TORTUOUS. THERE WERE NO ISSUES DURING STENT PLACEMENT. REPORTEDLY, THE PATIENT COMPLAINED OF ABDOMINAL PAIN POST-PROCEDURE. ON (B)(6) 2014, THE PATIENT COMPLAINED AGAIN OF ABDOMINAL PAIN AND IT WAS REPORTED THAT A PERFORATION WAS OBSERVED IN THE SIGMOID COLON. THE PATIENT UNDERWENT AN EMERGENCY SURGERY AND A STOMA WAS MADE. IN THE PHYSICIAN¿S ASSESSMENT, THE SURGERY WAS DUE TO THE PERFORATION, WHICH WAS POSSIBLY CAUSED BY THE NON-BSC GUIDEWIRE. HOWEVER, BSC WAS UNABLE TO OBTAIN CONFIRMATION OF THE PHYSICIAN¿S ASSESSMENT OF THE RELATIONSHIP BETWEEN THE STENT AND THE PERFORATION. ON (B)(6) 2014, IT WAS REPORTED THAT THE PATIENT¿S CONDITION WAS NOT GOOD. HOWEVER, ADDITIONAL FOLLOW UP ON (B)(6) 2014 NOTED THAT THE PATIENT¿S CONDITION IS NOW STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572741 WALLFLEX? COLONIC STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC - GALWAY M00565110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention