BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX? BILIARY

    MDR report key: 3181401 · Received June 21, 2013

    Report

    Report Number
    3005099803-2013-05456
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 31, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K061231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS PARTIALLY DEPLOYED BY APPROXIMATELY 30MM. IT WAS NOTED THAT A 0.035 INCH GUIDEWIRE WAS RETURNED INSERTED THROUGH THE DEVICE, THERE WERE NO ISSUES NOTED TO THE GUIDEWIRE. THE INNER SHAFT WAS KINKED AND PARTIALLY EXITING THE GUIDEWIRE ACCESS PORT. DURING ANALYSIS, WHEN THE DISTAL HANDLE WAS RETRACTED, THE INNER SHAFT FURTHER EXITED THE GUIDEWIRE ACCESS PORT AND THE OUTER SHEATH COULD NOT BE RETRACTED. THE SHAFT OF THE DEVICE WAS DISSECTED PROXIMAL TO THE GUIDEWIRE ACCESS PORT AND THE INNER SHAFT AND STENT WERE WITHDRAWN. EXAMINATION OF THE INNER SHAFT NOTED THAT IT WAS SEVERELY KINKED AND TWISTED PROXIMAL TO THE YELLOW INNER JACKET WHERE IT HAD EXITED THE GUIDEWIRE ACCESS PORT. EXAMINATION OF THE DEPLOYED STENT FOUND NO ANOMALIES. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION IS OPERATIONAL CONTEXT. THIS IS DEFINED AS A COMPLAINT THAT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN & MANUFACTURE SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED. 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 FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX UNCOVERED BILIARY STENT WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE WITH BILIARY STENT PLACEMENT IN THE INTRAHEPATIC LEFT CHANNEL AND BILIARY PERFORMED ON (B)(6) 2013. THE LESION WAS LOCATED AT THE HILUM IN THE BOTTOM OF THE BILE DUCT CAUSING MULTIPLE EXTRINSIC COMPRESSIONS OF THE DUCT. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR STENT PLACEMENT WAS DUE TO INTRADUCTAL PAPILLARY MUCINOUS TUMOR OF THE PANCREAS (IPMTP). THE PATIENT'S ANATOMY WAS VERY TORTUROUS. THE LESION WAS NOT DILATED PRIOR TO THE PROCEDURE. DURING THE PROCEDURE, THE DEVICE WAS ADVANCED INTO THE BILE DUCT AND THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT. THE STENT WOULD ONLY DEPLOY 2-3CM AND THE PHYSICIAN WAS UNABLE TO DEPLOY THE STENT. THE STENT COULD NOT BE RECONSTRAINED. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH SEVERAL DIFFERENT SHORTER STENTS. 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 A WALLFLEX UNCOVERED BILIARY STENT WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE WITH BILIARY STENT PLACEMENT IN THE INTRAHEPATIC LEFT CHANNEL AND BILIARY PERFORMED ON (B)(6) 2013. THE LESION WAS LOCATED AT THE HILUM IN THE BOTTOM OF THE BILE DUCT CAUSING MULTIPLE EXTRINSIC COMPRESSIONS OF THE DUCT. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR STENT PLACEMENT WAS DUE TO INTRADUCTAL PAPILLARY MUCINOUS TUMOR OF THE PANCREAS (IPMTP). THE PATIENT'S ANATOMY WAS VERY TORTUROUS. THE LESION WAS NOT DILATED PRIOR TO THE PROCEDURE. DURING THE PROCEDURE, THE DEVICE WAS ADVANCED INTO THE BILE DUCT AND THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT. THE STENT WOULD ONLY DEPLOY 2-3CM AND THE PHYSICIAN WAS UNABLE TO DEPLOY THE STENT. THE STENT COULD NOT BE RECONSTRAINED. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH SEVERAL DIFFERENT SHORTER STENTS. 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
    281684 WALLFLEX? BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570650 0015880400

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR