BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAF

    MDR report key: 1854581 · Received October 5, 2010

    Report

    Report Number
    3005099803-2010-04235
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K012883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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.

    Additional Manufacturer Narrative · 1

    AN INITIAL VISUAL EXAMINATION NOTED THAT THE DEVICE WAS RETURNED PARTIALLY DEPLOYED. THE DEPLOYMENT SUTURE WAS NOT BROKEN; RATHER, APPROXIMATELY 84MM OF IT HAD BEEN RELEASED. NO VISIBLE DAMAGE WAS NOTED TO THE CATHETER DELIVERY SYSTEM. THE REMAINDER OF THE DEPLOYMENT SUTURE WAS RETRACTED WITHOUT ISSUE, AND THE STENT DEPLOYED AS INTENDED. NO ISSUES WERE NOTED WITH THE STENT¿S PROFILE. THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT EVENT- THE DEPLOYMENT SUTURE WAS INTACT. THE STENT, HOWEVER, WAS RETURNED PARTIALLY DEPLOYED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT WAS USED DURING A STENTING PROCEDURE WITHIN THE LUNGS ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEPLOYMENT SUTURE BROKE WHEN THE PHYSICIAN TRIED TO DEPLOY THE STENT. THE PHYSICIAN NOTED THAT THERE WAS RESISTANCE WHEN AN ATTEMPT WAS MADE TO PULL ON THE STRING, AND THE STENT DID NOT DEPLOY. ADDITIONALLY, THE ANATOMY WAS TORTUOUS, AND THE STRICTURE WAS NOT PREDILATED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER ULTRAFLEX STENT. 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 TRACHEOBRONCHIAL COVERED STENT WAS USED DURING A STENTING PROCEDURE WITHIN THE LUNGS ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEPLOYMENT SUTURE BROKE WHEN THE PHYSICIAN TRIED TO DEPLOY THE STENT. THE PHYSICIAN NOTED THAT THERE WAS RESISTANCE WHEN AN ATTEMPT WAS MADE TO PULL ON THE STRING, AND THE STENT DID NOT DEPLOY. ADDITIONALLY, THE ANATOMY WAS TORTUOUS, AND THE STRICTURE WAS NOT PREDILATED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER ULTRAFLEX STENT. 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
    1 ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAF PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY M00569060 0013185668

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR