BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX? ESOPHAGEAL NG

    MDR report key: 3192967 · Received June 27, 2013

    Report

    Report Number
    3005099803-2013-05955
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE DISTAL END OF THE STENT WAS PARTIALLY DEPLOYED BY APPROXIMATELY 5 MM. DURING ANALYSIS, IT WAS POSSIBLE TO RETRACT THE REMAINDER OF THE DEPLOYMENT SUTURE THREAD AND DEPLOY THE STENT WITHOUT ANY ISSUE. IT WAS NOTED THAT THE SHAFT WAS KINKED AT SEVERAL LOCATIONS ALONG ITS LENGTH. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. THE INVESTIGATION CONCLUDED THAT THIS COMPLAINT IS ASSOCIATED WITH AN ACT OR OMISSION OF AN ACT THAT RESULTED IN A DIFFERENT MEDICAL DEVICE RESPONSE THAN INTENDED BY THE MANUFACTURER OR EXPECTED BY THE USER. THE DIRECTIONS FOR USE (DFU) ADVISES TO BEGIN DEPLOYMENT OF THE STENT ONLY AFTER THE STENT SYSTEM HAS BEEN ADVANCED OVER THE GUIDEWIRE AND POSITIONED WITHIN THE STRICTURE. HOWEVER, IN THIS CASE, THE PHYSICIAN BEGAN DEPLOYMENT OF THE STENT OUTSIDE OF THE PATIENT. THE DFU STATES "FOR DISTAL RELEASE SYSTEMS PUSHING DISTALLY (AWAY FROM THE OPERATOR) THE DELIVERY SYSTEM SHOULD NOT BE ATTEMPTED AFTER PARTIAL STENT DEPLOYMENT". HOWEVER, IN THIS CASE, THE PARTIALLY DEPLOYED STENT WAS INSERTED INTO THE PATIENT AND PUSHED DISTALLY. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS USER/USE ERROR. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESPOPHAGEAL STENT WAS USED DURING AN ESOPHAGEAL STENT IMPLANT PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, INDICATION FOR THE PROCEDURE WAS TREATMENT OF AN ESOPHAGEAL STRICTURE DUE TO CANCER. THE STRICTURE WAS NOT DILATED PRIOR TO STENT PLACEMENT AND THE ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE SCOPE WAS PASSED THROUGH THE STRICTURE AND THE LENGTH OF THE STRICTURE WAS NOTED. THE PHYSICIAN, ADVANCED A GUIDEWIRE THROUGH THE STRICTURE AND THE SCOPE WAS WITHDRAWN. THE STENT WAS SLOWLY PASSED OVER THE GUIDEWIRE UNDER FLUOROSCOPY. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE STENT FAILED TO DEPLOY AND THE CATHETER BEGAN TO KINK AT THE DISTAL END. THE STENT SYSTEM WAS REMOVED FROM THE PATIENT. ONCE OUTSIDE OF THE PATIENT, A PORTION OF THE DEPLOYMENT SUTURE THREAD WAS ABLE TO BE RELEASED FREELY. THE STENT SYSTEM WAS INSERTED BACK INTO THE PATIENT AND POSITIONED AT THE TARGET SITE. HOWEVER AGAIN, THE STENT COULD NOT BE DEPLOYED. THE STENT WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESPOPHAGEAL STENT WAS USED DURING AN ESOPHAGEAL STENT IMPLANT PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, INDICATION FOR THE PROCEDURE WAS TREATMENT OF AN ESOPHAGEAL STRICTURE DUE TO CANCER. THE STRICTURE WAS NOT DILATED PRIOR TO STENT PLACEMENT AND THE ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE SCOPE WAS PASSED THROUGH THE STRICTURE AND THE LENGTH OF THE STRICTURE WAS NOTED. THE PHYSICIAN, ADVANCED A GUIDEWIRE THROUGH THE STRICTURE AND THE SCOPE WAS WITHDRAWN. THE STENT WAS SLOWLY PASSED OVER THE GUIDEWIRE UNDER FLUOROSCOPY. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE STENT FAILED TO DEPLOY AND THE CATHETER BEGAN TO KINK AT THE DISTAL END. THE STENT SYSTEM WAS REMOVED FROM THE PATIENT. ONCE OUTSIDE OF THE PATIENT, A PORTION OF THE DEPLOYMENT SUTURE THREAD WAS ABLE TO BE RELEASED FREELY. THE STENT SYSTEM WAS INSERTED BACK INTO THE PATIENT AND POSITIONED AT THE TARGET SITE. HOWEVER AGAIN, THE STENT COULD NOT BE DEPLOYED. THE STENT WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294471 ULTRAFLEX? ESOPHAGEAL NG PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00513740 15787555

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR