BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX? BILIARY TRANSHEPATIC

    MDR report key: 2707907 · Received August 21, 2012

    Report

    Report Number
    3005099803-2012-03526
    Event Type
    Injury
    Date Received
    August 21, 2012
    Date of Event
    July 27, 2012
    Report Date
    July 27, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K112543
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510K #: K112543.

    Additional Manufacturer Narrative · 1

    COMPONENT RELATES TO PROBLEM FOR THE REPORTED EVENT OF STENT POSITIONING PROBLEM. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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.

    Additional Manufacturer Narrative · 1

    REPORTED ISSUE OF STENT POSITIONING ISSUE. REPORTED ISSUE OF CATHETER DIFFICULT TO REMOVE/WITHDRAW. THE DEVICE WAS NOT RETURNED; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. 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 SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE INVESTIGATION CONCLUDED THAT THIS COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY TRANSHEPATIC STENT 10MM X 60MM WAS USED DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY PROCEDURE WITH STENT PLACEMENT PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS IN POSITION AND DEPLOYED. HOWEVER, WHEN THE PHYSICIAN WENT TO REMOVE THE DELIVERY SYSTEM IT WAS CAUGHT ON THE STENT. SEVERAL ATTEMPTS WERE MADE TO FREE THE DELIVERY SYSTEM WHILE NOT DISTURBING THE STENT, BUT THE STENT MOVED. THE DELIVERY SYSTEM WAS REMOVED AND THE STENT WAS LEFT IMPLANTED IN AN INCORRECT POSITION. A SECOND STENT (A WALLFLEX BILIARY TRANSHEPATIC STENT 10MM X 80MM) WAS PLACED TO COMPLETE THE PROCEDURE. 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY TRANSHEPATIC STENT 10MM X 60MM WAS USED DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY PROCEDURE WITH STENT PLACEMENT PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS IN POSITION AND DEPLOYED. HOWEVER, WHEN THE PHYSICIAN WENT TO REMOVE THE DELIVERY SYSTEM IT WAS CAUGHT ON THE STENT. SEVERAL ATTEMPTS WERE MADE TO FREE THE DELIVERY SYSTEM WHILE NOT DISTURBING THE STENT, BUT THE STENT MOVED. THE DELIVERY SYSTEM WAS REMOVED AND THE STENT WAS LEFT IMPLANTED IN AN INCORRECT POSITION. A SECOND STENT (A WALLFLEX BILIARY TRANSHEPATIC STENT 10MM X 80MM) WAS PLACED TO COMPLETE THE PROCEDURE. 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY TRANSHEPATIC STENT 10MM X 60MM WAS USED DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY PROCEDURE WITH STENT PLACEMENT PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS IN POSITION AND DEPLOYED. HOWEVER, WHEN THE PHYSICIAN WENT TO REMOVE THE DELIVERY SYSTEM IT WAS CAUGHT ON THE STENT. SEVERAL ATTEMPTS WERE MADE TO FREE THE DELIVERY SYSTEM WHILE NOT DISTURBING THE STENT, BUT THE STENT MOVED. THE DELIVERY SYSTEM WAS REMOVED AND THE STENT WAS LEFT IMPLANTED IN AN INCORRECT POSITION. A SECOND STENT (A WALLFLEX BILIARY TRANSHEPATIC STENT 10MM X 80MM) WAS PLACED TO COMPLETE THE PROCEDURE. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX? BILIARY TRANSHEPATIC CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00574780 0015107798

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention