BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX NEEDLE KNIFE XL

    MDR report key: 3830257 · Received May 23, 2014

    Report

    Report Number
    3005099803-2014-01882
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KNS
    PMA / PMN Number
    K973826
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. REPORTED EVENT: NEEDLE BROKE. 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 MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THE CUTTING WIRE BROKEN AND BLACKENED. 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. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION FOR THE REPORTED FAILURE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO DEVIATION WAS FOUND. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. LABELING REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND. BASED ON THE INFORMATION PROVIDED, IT IS DIFFICULT TO DETERMINE IF THE DEVICE WAS USED IN ACCORDANCE WITH THE LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN FG NEEDLEKNIFE RX WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER A SPHINCTEROTOMY WAS PERFORMED, WHEN THE PHYSICIAN PULLED THE DEVICE OUT OF THE SCOPE, THEY NOTICED THAT THE NEEDLE BROKE OFF AND DETACHED. THEY TRIED TO RETRIEVE THE DETACHED PORTION OF THE NEEDLE KNIFE USING A RAT TOOTH FORCEPS; HOWEVER, IT WAS NOT SUCCESSFULLY RETRIEVED. A PERFORATION OF THE DUODENUM WAS NOTED. THE PHYSICIAN PLACED A GUIDEWIRE, THEN USED A FULLY COVERED WALLFLEX BILIARY STENT TO SEAL THE PERFORATION. 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 AN FG NEEDLEKNIFE RX WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER A SPHINCTEROTOMY WAS PERFORMED, WHEN THE PHYSICIAN PULLED THE DEVICE OUT OF THE SCOPE, THEY NOTICED THAT THE NEEDLE BROKE OFF AND DETACHED. THEY TRIED TO RETRIEVE THE DETACHED PORTION OF THE NEEDLE KNIFE USING A RAT TOOTH FORCEPS; HOWEVER IT WAS NOT SUCCESSFULLY RETRIEVED. A PERFORATION OF THE DUODENUM WAS NOTED. THE PHYSICIAN PLACED A GUIDEWIRE, THEN USED A FULLY COVERED WALLFLEX BILIARY STENT TO SEAL THE PERFORATION. 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
    307661 RX NEEDLE KNIFE XL UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00545840 16433430

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention