BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM

    MDR report key: 1811822 · Received August 24, 2010

    Report

    Report Number
    3005099803-2010-03614
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MQR
    PMA / PMN Number
    K061877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS DEPLOYED BY APPROXIMATELY 16MM. THE CLEAR OUTER SHEATH WAS KINKED AT APPROXIMATELY 255MM PROXIMAL TO THE DISTAL END OF THE OUTER SHEATH. THE DISTAL HANDLE WAS DETACHED FROM THE OUTER SHEATH, WHICH IS DAMAGE CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE SHAFT. ADDITIONALLY, THE STAINLESS STEEL SHAFT WAS BENT. DURING A FUNCTIONAL ANALYSIS, IT WAS POSSIBLE TO FULLY DEPLOY THE STENT WITHOUT ISSUE. THERE WERE NO PROBLEMS WITH THE MOVEMENT OF THE OUTER SHEATH, AND NO ISSUES WERE NOTED WITH THE STENT'S PROFILE. THE INNER LUMEN, HOWEVER, WAS KINKED 22MM PROXIMAL FROM THE DISTAL TIP. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT EVENT. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, 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 TO TREAT A MALIGNANT STRICTURE WITHIN THE COLON ON (B)(4), 2010. ACCORDING TO THE COMPLAINANT, THE WALLFLEX STENT SYSTEM WAS ADVANCED OVER A .035" HYDRA JAGWIRE. THE STENT SYSTEM WAS NOT PLACED THROUGH A COLONOSCOPE AS THE CORRECT COLONOSCOPE WAS NOT READILY AVAILABLE IN THE OR. WHILE ATTEMPTING TO DEPLOY THE STENT, THE NURSE ENCOUNTERED SIGNIFICANT RESISTANCE. AS A RESULT, THE NURSE NEEDED TO APPLY ADDITIONAL FORCE TO THE DISTAL HANDLE TO BEGIN DEPLOYING THE STENT. WHEN THE STENT WAS APPROXIMATELY 5% DEPLOYED, THE DISTAL HANDLE SLID COMPLETELY BACK TO THE PROXIMAL HANDLE; THE STENT COULD NOT BE DEPLOYED ANY FURTHER, NOR COULD IT BE RECONSTRAINED. THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT. THE COMPLAINANT NOTED NO VISIBLE DAMAGE TO THE STENT OR CATHETER SYSTEM. TO COMPLETE THE PROCEDURE, THE PHYSICIAN INSERTED A THERAPEUTIC COLONOSCOPE INTO THE PATIENT. A 9CM WALLFLEX COLONIC STENT SYSTEM 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 GOOD. IT WAS ESTIMATED THAT THIS DEVICE ISSUE DELAYED THE PROCEDURE BY 15 MINUTES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS USED TO TREAT A MALIGNANT STRICTURE WITHIN THE COLON ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE WALLFLEX STENT SYSTEM WAS ADVANCED OVER A .035' HYDRA JAGWIRE. THE STENT SYSTEM WAS NOT PLACED THROUGH A COLONOSCOPE AS THE CORRECT COLONOSCOPE WAS NOT READILY AVAILABLE IN THE OR. WHILE ATTEMPTING TO DEPLOY THE STENT, THE NURSE ENCOUNTERED SIGNIFICANT RESISTANCE. AS A RESULT, THE NURSE NEEDED TO APPLY ADDITIONAL FORCE TO THE DISTAL HANDLE TO BEGIN DEPLOYING THE STENT. WHEN THE STENT WAS APPROXIMATELY 5% DEPLOYED, THE DISTAL HANDLE SLID COMPLETELY BACK TO THE PROXIMAL HANDLE; THE STENT COULD NOT BE DEPLOYED ANY FURTHER, NOR COULD IT BE RECONSTRAINED. THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT. THE COMPLAINANT NOTED NO VISIBLE DAMAGE TO THE STENT OR CATHETER SYSTEM. TO COMPLETE THE PROCEDURE, THE PHYSICIAN INSERTED A THERAPEUTIC COLONOSCOPE INTO THE PATIENT. A 9CM WALLFLEX COLONIC STENT SYSTEM 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 GOOD. IT WAS ESTIMATED THAT THIS DEVICE ISSUE DELAYED THE PROCEDURE BY 15 MINUTES.

    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 M00565060 0013250244

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR .035" HYDRA JAGWIRE