BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA¿ BILIARY

    MDR report key: 2213289 · Received August 16, 2011

    Report

    Report Number
    3005099803-2011-02743
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE AND WEIGHT ARE UNKNOWN. IT WAS REPORTED THE PATIENT WAS OVER 18 YEARS OLD. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, 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 MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED PRODUCT REVEALED THAT THE STENT WAS DETACHED FROM THE DELIVERY SYSTEM. THE SUTURE WAS NOT INTACT AT THE DISTAL END OF THE PUSH CATHETER AND WAS NOT RETURNED FOR EVALUATION. NO DAMAGES WERE OBSERVED TO THE STENT. THE SUTURE HOLE ON THE PUSH CATHETER WAS TORN. DUE TO CONSIDERABLE RESISTANCE, THE GUIDE CATHETER COULD NOT BE COMPLETELY REMOVED FROM THE PUSH CATHETER. THE DISTAL END OF THE GUIDE CATHETER WAS FOUND TO HAVE AN OBVIOUS KINK/BEND (SUTURE IMPRESSION) WHICH INDICATED THAT THE SUTURE LIKELY EMBEDDED INSIDE THE GUIDE CATHETER ASSEMBLY DURING USE. THE TARGET SITE (STRICTURE) WAS TIGHT, WHICH POTENTIALLY LIMITED THE OVERALL PERFORMANCE OF THE DEVICE. PROCEDURAL FACTORS MAY HAVE CAUSED THE SUTURE TO EMBED INSIDE THE DISTAL END OF THE GUIDE CATHETER LEADING TO SUTURE BREAKING INADVERTENTLY AND PREMATURE DEPLOYMENT OF STENT DURING USE. BASED ON THE CONDITION OF THE RETURNED DEVICE AND THE EVALUATION CONDUCTED, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUES IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED THAT COULD BE RELATED TO THIS COMPLAINT. A REVIEW OF COMPLAINT HISTORY FOR THE REPORTED LOT NUMBER WAS PERFORMED AND CONCLUDED THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT A FLEXIMA BILIARY STENT WAS USED DURING A STONE REMOVAL PROCEDURE OF THE COMMON BILE DUCT PERFORMED ON A FEMALE PATIENT ON (B)(6), 2011 (PATIENT AGE AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE INNER CATHETER WAS ADVANCED TO THE TARGET SITE, HOWEVER THE STENT WAS UNABLE TO BE INSERTED AT THIS LOCATION. THE TARGET SITE WAS REPORTED TO BE A TIGHT STRICTURE. THE PHYSICIAN THEN ATTEMPTED TO WITHDRAW THE DEVICE, HOWEVER THE SUTURE DETACHED AND THE STENT DEPLOYED PREMATURELY. THIS STENT WAS REMOVED FROM THE PATIENT. THE SUTURE DID NOT DETACH INSIDE THE PATIENT AND NO OTHER DAMAGE WAS NOTED TO THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2011 THAT A FLEXIMA BILIARY STENT WAS USED DURING A STONE REMOVAL PROCEDURE OF THE COMMON BILE DUCT PERFORMED ON A FEMALE PATIENT ON (B)(6) 2011 (PATIENT AGE AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE INNER CATHETER WAS ADVANCED TO THE TARGET SITE, HOWEVER THE STENT WAS UNABLE TO BE INSERTED AT THIS LOCATION. THE TARGET SITE WAS REPORTED TO BE A TIGHT STRICTURE. THE PHYSICIAN THEN ATTEMPTED TO WITHDRAW THE DEVICE, HOWEVER THE SUTURE DETACHED AND THE STENT DEPLOYED PREMATURELY. THIS STENT WAS REMOVED FROM THE PATIENT. THE SUTURE DID NOT DETACH INSIDE THE PATIENT AND NO OTHER DAMAGE WAS NOTED TO THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA¿ BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M00539260 14325593

    Patients

    Seq Age Sex Outcome Treatment
    1