BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX? BILIARY

    MDR report key: 3092030 · Received May 3, 2013

    Report

    Report Number
    3005099803-2013-03310
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS PARTIALLY DEPLOYED BY APPROXIMATELY 28 MM. IT WAS NOTED THAT THE INNER LUMEN WAS EXITING AT THE GUIDEWIRE EXIT PORT AND WAS KINKED. DURING ANALYSIS AN ATTEMPT COULD NOT BE MADE TO RETRACT THE OUTER SHEATH AND DEPLOY THE STENT DUE TO THE CONDITION OF THE RETURNED DEVICE. THE SHAFT WAS DISSECTED PROXIMAL TO THE GUIDEWIRE ACCESS SLEEVE AND THE DISTAL END OF THE INNER LUMEN AND STENT WERE WITHDRAWN FROM THE OUTER SHEATH. NO ISSUES WERE NOTED WITH THE PROFILE OF THE DEPLOYED STENT THAT WOULD HAVE CONTRIBUTED TO THE COMPLAINT REPORTED. THE INNER LUMEN WAS KINKED FROM WHERE IT HAD EXITED THE GUIDEWIRE ACCESS PORT. NO ISSUES WERE NOTED IN MOVEMENT OF THE OUTER SHEATH OF THE PROXIMAL END OF THE SHAFT AFTER IT HAD BEEN DISSECTED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH. THE INVESTIGATION CONCLUDED THAT THE COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE OF THE DEVICE WAS LIMITED. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF STENT PARTIALLY DEPLOYED. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. 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 BILIARY STENT WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE WITH BILIARY STENT PLACEMENT PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR STENT PLACEMENT WAS TO TREAT OBSTRUCTIVE JAUNDICE DUE TO A MALIGNANT STRICTURE IN THE DISTAL COMMON BILE DUCT SECONDARY TO CHOLANGIOCARCINOMA. THE PATIENT'S ANATOMY WAS NOT TORTUROUS. THE LESION WAS NOT DILATED PRIOR TO THE PROCEDURE. DURING THE PROCEDURE, THE DEVICE WAS ADVANCED INTO THE BILE DUCT AND WHEN ATTEMPTING TO DEPLOY THE STENT THE PHYSICIAN HEARD A "CRACK" SOUND. THE PHYSICIAN COULD NOT COMPLETELY DEPLOY THE STENT. THE STENT COULD NOT BE RECONSTRAINED. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY 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 ¿SAFE¿ AND ¿STABLE¿.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE WITH BILIARY STENT PLACEMENT PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR STENT PLACEMENT WAS TO TREAT OBSTRUCTIVE JAUNDICE DUE TO A MALIGNANT STRICTURE IN THE DISTAL COMMON BILE DUCT SECONDARY TO CHOLANGIOCARCINOMA. THE PATIENT'S ANATOMY WAS NOT TORTUROUS. THE LESION WAS NOT DILATED PRIOR TO THE PROCEDURE. DURING THE PROCEDURE, THE DEVICE WAS ADVANCED INTO THE BILE DUCT AND WHEN ATTEMPTING TO DEPLOY THE STENT THE PHYSICIAN HEARD A "CRACK" SOUND. THE PHYSICIAN COULD NOT COMPLETELY DEPLOY THE STENT. THE STENT COULD NOT BE RECONSTRAINED. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY 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 "SAFE" AND "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194028 WALLFLEX? BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570740 15607274

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR