BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX

    MDR report key: 1961725 · Received January 14, 2011

    Report

    Report Number
    3005099803-2011-00064
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 24, 2010
    Report Date
    December 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K955347
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE PRESENTED WITH THE STENT PARTIALLY DEPLOYED BY ABOUT 55MM, WITH NO ISSUES NOTED TO THE CROCHET STITCHES. NO BENDS OR KINKS WERE NOTED ALONG THE DELIVERY CATHETER. DURING A FUNCTIONAL ANALYSIS, THERE WAS SOME INITIAL RESISTANCE WHEN RETRACTING THE SUTURE; HOWEVER, THE REMAINDER OF THE STENT COULD BE DEPLOYED. NO ISSUES WERE NOTED WITH THE PROFILE OF THE STENT. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT EVENT. 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 AN ULTRAFLEX ESOPHAGEAL STENT WAS USED DURING A STENTING PROCEDURE WITHIN THE LOWER ESOPHAGUS ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, AFTER ABOUT HALF OF THE STENT HAD BEEN DEPLOYED, THE PHYSICIAN ENCOUNTERED RESISTANCE. DESPITE EXTRA EFFORTS PULLING ON THE SUTURE, THE REMAINDER OF THE STENT WOULD NOT DEPLOY. THE DEVICE WAS REMOVED FROM THE PATIENT IN A PARTIALLY DEPLOYED STATE AND THE PROCEDURE WAS ABORTED AT THIS TIME. THE PHYSICIAN NOTED THAT THE ANATOMY WAS NOT TORTUOUS. 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. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT TYPE OF STENT ON (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL STENT WAS USED DURING A STENTING PROCEDURE WITHIN THE LOWER ESOPHAGUS ON (B)(6), 2010.ACCORDING TO THE COMPLAINANT, AFTER ABOUT HALF OF THE STENT HAD BEEN DEPLOYED, THE PHYSICIAN ENCOUNTERED RESISTANCE. DESPITE EXTRA EFFORTS PULLING ON THE SUTURE, THE REMAINDER OF THE STENT WOULD NOT DEPLOY.THE DEVICE WAS REMOVED FROM THE PATIENT IN A PARTIALLY DEPLOYED STATE AND THE PROCEDURE WAS ABORTED AT THIS TIME. THE PHYSICIAN NOTED THAT THE ANATOMY WAS NOT TORTUOUS.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.THE PROCEDURE WAS COMPLETED WITH A DIFFERENT TYPE OF STENT ON (B)(6), 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00514070 13215871

    Patients

    Seq Age Sex Outcome Treatment
    1