BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX

    MDR report key: 2001344 · Received February 25, 2011

    Report

    Report Number
    3005099803-2011-00481
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K955347
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    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 IDENTIFIED THAT THIS DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE (DFU). THE DFU STATES THAT ULTRAFLEX STENT SYSTEM IS CONTRAINDICATED FOR PLACEMENT IN AN ESOPHAGO-JEJUNOSTOMY. HOWEVER, THE COMPLAINT STATES THAT THE DEVICE WAS INTENDED TO BE USED IN AN ESOPHAGO-JEJUNOSTOMY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX COVERED ESOPHAGEAL STENT WAS USED DURING A STENTING PROCEDURE WITHIN THE ESOPHAGUS ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN COULD NOT ADVANCE THE STENT DELIVERY SYSTEM THROUGH THE TARGET STENOSIS DUE TO THE TORTUOUS NATURE OF THE PATIENT ANATOMY. THE PHYSICIAN ADDED THAT THE DELIVERY SYSTEM OF THE DEVICE BECAME BENT DURING THE REPEATED ATTEMPTS TO ADVANCE. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE. AS A PRECAUTION, THE PHYSICIAN PERFORMED A CONTRAST TEST, WHEN IT WAS NOTICED THAT CONTRAST MEDIA WAS LEAKING INTO THE ABDOMINAL CAVITY; THE PATIENT HAD SUFFERED A LACERATION OF THE ESOPHAGUS. THE PHYSICIAN PLACED A DRAIN TUBE AND CONCLUDED THE PROCEDURE. THERE IS NO UPDATE ON THE PATIENT'S CONDITION. THE PHYSICIAN WAS TAKING A WAIT AND SEE APPROACH. IT WAS NOTED THAT NO PRE-DILATION OF THE ANATOMY WAS PERFORMED. THE PHYSICIAN SUSPECTS THAT THE CAUSE OF THE ISSUE WAS DUE TO THE TORTUOUS NATURE OF THE ANATOMY. ALSO, THE PATIENT HAD PREVIOUSLY UNDERGONE AN ESOPHAGOJEJUNOSTOMY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX COVERED ESOPHAGEAL STENT WAS USED DURING A STENTING PROCEDURE WITHIN THE ESOPHAGUS ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN COULD NOT ADVANCE THE STENT DELIVERY SYSTEM THROUGH THE TARGET STENOSIS DUE TO THE TORTUOUS NATURE OF THE PATIENT' ANATOMY. THE PHYSICIAN ADDED THAT THE DELIVERY SYSTEM OF THE DEVICE BECAME BENT DURING THE REPEATED ATTEMPTS TO ADVANCE. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE. AS A PRECAUTION, THE PHYSICIAN PERFORMED A CONTRAST TEST, WHEN IT WAS NOTICED THAT CONTRAST MEDIA WAS LEAKING INTO THE ABDOMINAL CAVITY; THE PATIENT HAD SUFFERED A LACERATION OF THE ESOPHAGUS. THE PHYSICIAN PLACED A DRAIN TUBE AND CONCLUDED THE PROCEDURE. THERE IS NO UPDATE ON THE PATIENT'S CONDITION. THE PHYSICIAN WAS TAKING A 'WAIT AND SEE' APPROACH. IT WAS NOTED THAT NO PRE-DILATION OF THE ANATOMY WAS PERFORMED. THE PHYSICIAN SUSPECTS THAT THE CAUSE OF THE ISSUE WAS DUE TO THE TORTUOUS NATURE OF THE ANATOMY. ALSO, THE PATIENT HAD PREVIOUSLY UNDERGONE AN ESOPHAGOJEJUNOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00514100 0013296493

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention