BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM

    MDR report key: 1834598 · Received September 15, 2010

    Report

    Report Number
    3005099803-2010-03947
    Event Type
    Injury
    Date Received
    September 15, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 25, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MQR
    PMA / PMN Number
    K061877
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NON-SURGICAL MEDICAL INTERVENTION REQUIRED.(B)(4) CATHETER TIP BREAK.THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION (STENT IMPLANTED, DELIVERY SYSTEM DISPOSED); THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT 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 THAT A WALLFLEX ENTERAL COLONIC STENT WAS USED DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS BEING TREATED FOR A MALIGNANT STRICTURE WITHIN THE RECTOSIGMOID COLON. DURING REMOVAL OF THE DELIVERY SYSTEM AFTER A SUCCESSFUL STENT DEPLOYMENT, A 2CM PIECE OF THE TIP BROKE OFF THE DELIVERY SYSTEM AND FELL INTO THE PATIENT. THE 2CM PIECE WAS RETRIEVED FROM THE PATIENT BY USING BIOPSY FORCEPS. 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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A WALLFLEX ENTERAL COLONIC STENT WAS USED DURING A COLONOSCOPY PROCEDURE ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS BEING TREATED FOR A MALIGNANT STRICTURE WITHIN THE RECTOSIGMOID COLON. DURING REMOVAL OF THE DELIVERY SYSTEM AFTER A SUCCESSFUL STENT DEPLOYMENT, A 2CM PIECE OF THE TIP BROKE OFF THE DELIVERY SYSTEM AND FELL INTO THE PATIENT. THE 2CM PIECE WAS RETRIEVED FROM THE PATIENT BY USING BIOPSY FORCEPS. 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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION RECEIVED ON (B)(6), 2010. IT IS SUSPECTED THAT WHILE TRYING TO REMOVE THE DELIVERY SYSTEM, THE TIP OF THE CATHETER GOT STUCK ON A PORTION OF THE STENT, SO WHEN THE PHYSICIAN PULLED ON THE DELIVERY SYSTEM, THE TIP BROKE OFF. THE STENT DID NOT MIGRATE OR MOVE AS A RESULT OF THIS ISSUE. THE ANATOMY WAS MODERATELY TORTUOUS. THE COMPLAINANT DID CONFIRM THAT THE PATIENT WAS DOING GREAT FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC - GALWAY M00565100 13596225

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention