BEUDAMED
    FDA Adverse Event Death Summary report: N

    JAGWIRE

    MDR report key: 1617060 · Received February 28, 2010

    Report

    Report Number
    3005099803-2010-01046
    Event Type
    Death
    Date Received
    February 28, 2010
    Date of Event
    January 7, 2010
    Report Date
    February 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B) (4) - NO CODE AVAILABLE (MEDICAL INTERVENTION REQUIRED, BLEEDING). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B) (6) 2010. ACCORDING TO THE COMPLAINANT, A WALLSTENT WAS PLACED ON (B) (6) 2009 IN THE MID/DISTAL BILIARY TRACT FOR STAGE IV INOPERABLE CHOLANGIOCARCINOMA. A COTTON LUNG PLASTIC BILIARY STENT THAT WAS PLACED ON (B) (6) 2009 IN THE BILIARY DUCT WAS FOUND IN THE MAJOR PAPILLA AND REMOVED DURING THE SAME PROCEDURE. NO COMPLICATIONS WERE REPORTED DURING THIS PROCEDURE. THERE WAS ADEQUATE BILIARY DRAINAGE POST STENT PLACEMENT. AN ERCP WAS PERFORMED ON (B) (6) 2009 FOR SUSPECTED OBSTRUCTION OF THE WALLSTENT. THE STENT WAS DISCOVERED TO HAVE MIGRATED TO THE MAJOR PAPILLA. CANNULATION OF THE BILIARY DUCT WAS SUCCESSFUL AND DEEP WITH A NON-BSC SPHINCTEROTOME. THE WALLSTENT APPEARED TO BE OBSTRUCTED WITH DEBRIS THAT COULD NOT BE REMOVED SUCCESSFULLY, SO THE WALLSTENT WAS REMOVED VIA A NON-BSC SNARE. A SINGLE, IRREGULAR STRICTURE OF MALIGNANT APPEARANCE WAS SEEN AT THE LOWER AND MIDDLE THIRD OF THE COMMON BILE DUCT. A WALLFLEX BILIARY STENT WAS PLACED SUCCESSFULLY. THE PATIENT BEGAN RECEIVING CIPROFLOXACIN 400 MG IV EVERY 12 HOURS. AN ERCP WAS PERFORMED ON (B) (6) 2009 TO ASSESS STENT POSITION WITH POSSIBLE MANIPULATION BECAUSE THE PATIENT HAD SLOWLY RISING LFT¿S (LIVER FUNCTION TESTS), JAUNDICE AND GRAM NEGATIVE SEPSIS. EROSIONS IN THE DUODENAL BULB WERE NOTED. IN THE SECOND PORTION OF THE DUODENUM, A LARGE ULCER CRATER WAS SEEN, WITH THE STENT VISIBLE EMERGING FROM THE ULCERATED AREA. THE COMPLAINANT STATED THAT IT WAS POSSIBLE THE STENT HAD ERODED THROUGH THE BILE DUCT TUMOR. THE DISTAL END OF THE STENT WAS IMPACTED IN THE DUODENAL WALL. CONTRAST WAS INJECTED INTO THE DUODENUM, WHICH INDICATED THAT THE DISTAL PORTION OF THE STENT WAS LYING WITHIN THE BOWEL LUMEN. NO EXTRAVASATION OF CONTRAST WAS NOTED. AT THE COMPLETION OF THIS PROCEDURE, THE PATIENT CONTINUED TO RECEIVE IV ANTIBIOTICS. AN ERCP WAS PERFORMED ON (B) (6) 2010 FOR RISING LFT¿S. THE WALLFLEX WAS ASSESSED AS DRAINING INADEQUATELY DUE TO POSITION. ULCERATION WAS NOTED AS PREVIOUSLY IN THE DUODENUM. THE STENT WAS SEEN AS BEFORE WITH THE DISTAL END NOT VISIBLE ENDOSCOPICALLY. THE PHYSICIAN THEN PUNCTURED THE PLASTIC COVERING OF THE STENT WITH A HYDRA GUIDEWIRE, AND A WIRE GUIDED CANNULATION OF THE STENT WAS PERFORMED USING AN RX RETRIEVAL BALLOON CATHETER. THE STENT WAS OPACIFIED WITH CONTRAST, AND CONTRAST FLOWED INTO THE RIGHT AND LEFT INTRAHEPATIC DUCTS, INDICATING THAT THE PROXIMAL END OF THE STENT WAS IN A GOOD POSITION. AIR WAS ALSO VISIBLE IN THE INTRAHEPATIC DUCTS, INDICATING STENT PATENCY. ARGON PLASMA COAGULATION WAS USED TO CREATE A LARGE DEFECT IN THE INTRADUODENAL PORTION OF THE STENT TO ALLOW ADEQUATE BILIARY DRAINAGE. THE PATIENT TOLERATED THE PROCEDURE WELL, AND THERE WERE NO COMPLICATIONS REPORTED. NO ISSUES WERE REPORTED WITH THE HYDRA GUIDEWIRE OR THE RX RETRIEVAL BALLOON CATHETER. ACCORDING TO THE COMPLAINANT, NO BLEEDING WAS NOTED DURING ANY OF THE ERCP'S. ON (B) (6) 2010, THE PATIENT EXPERIENCED BLEEDING AS EVIDENCED BY BLACK STOOLS AND WORSENING JAUNDICE. THE PATIENT WAS TREATED WITH BLOOD TRANSFUSIONS IN THE ICU. ON AN UNKNOWN DATE, THE PATIENT WENT HOME TO HOSPICE CARE AT THE FAMILY¿S REQUEST, AND DIED ON (B) (6) 2010. THE CAUSE OF DEATH WAS UNKNOWN, BUT THE PHYSICIAN ASSESSED AS POSSIBLY DUE TO BLEEDING AND POSSIBLY STENT PERFORATION RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B) (6) 2010. ACCORDING TO THE COMPLAINANT, A WALLSTENT WAS PLACED ON (B) (6) 2009 IN THE MID/DISTAL BILIARY TRACT FOR STAGE IV INOPERABLE CHOLANGIOCARCINOMA. A COTTON LUNG PLASTIC BILIARY STENT THAT WAS PLACED ON (B) (6) 2009 IN THE BILIARY DUCT WAS FOUND IN THE MAJOR PAPILLA AND REMOVED DURING THE SAME PROCEDURE. NO COMPLICATIONS WERE REPORTED DURING THIS PROCEDURE. THERE WAS ADEQUATE BILIARY DRAINAGE POST STENT PLACEMENT. AN ERCP WAS PERFORMED ON (B) (6) 2009 FOR SUSPECTED OBSTRUCTION OF THE WALLSTENT. THE STENT WAS DISCOVERED TO HAVE MIGRATED TO THE MAJOR PAPILLA. CANNULATION OF THE BILIARY DUCT WAS SUCCESSFUL AND DEEP WITH A NON-BSC SPHINCTEROTOME. THE WALLSTENT APPEARED TO BE OBSTRUCTED WITH DEBRIS THAT COULD NOT BE REMOVED SUCCESSFULLY, SO THE WALLSTENT WAS REMOVED VIA A NON-BSC SNARE. A SINGLE, IRREGULAR STRICTURE OF MALIGNANT APPEARANCE WAS SEEN AT THE LOWER AND MIDDLE THIRD OF THE COMMON BILE DUCT. A WALLFLEX BILIARY STENT WAS PLACED SUCCESSFULLY. THE PATIENT BEGAN RECEIVING CIPROFLOXACIN 400 MG IV EVERY 12 HOURS. AN ERCP WAS PERFORMED ON (B) (6) 2009 TO ASSESS STENT POSITION WITH POSSIBLE MANIPULATION BECAUSE THE PATIENT HAD SLOWLY RISING LFT¿S (LIVER FUNCTION TESTS), JAUNDICE AND GRAM NEGATIVE SEPSIS. EROSIONS IN THE DUODENAL BULB WERE NOTED. IN THE SECOND PORTION OF THE DUODENUM, A LARGE ULCER CRATER WAS SEEN, WITH THE STENT VISIBLE EMERGING FROM THE ULCERATED AREA. THE COMPLAINANT STATED THAT IT WAS POSSIBLE THE STENT HAD ERODED THROUGH THE BILE DUCT TUMOR. THE DISTAL END OF THE STENT WAS IMPACTED IN THE DUODENAL WALL. CONTRAST WAS INJECTED INTO THE DUODENUM, WHICH INDICATED THAT THE DISTAL PORTION OF THE STENT WAS LYING WITHIN THE BOWEL LUMEN. NO EXTRAVASATION OF CONTRAST WAS NOTED. AT THE COMPLETION OF THIS PROCEDURE, THE PATIENT CONTINUED TO RECEIVE IV ANTIBIOTICS. AN ERCP WAS PERFORMED ON (B) (6) 2010 FOR RISING LFT¿S. THE WALLFLEX WAS ASSESSED AS DRAINING INADEQUATELY DUE TO POSITION. ULCERATION WAS NOTED AS PREVIOUSLY IN THE DUODENUM. THE STENT WAS SEEN AS BEFORE WITH THE DISTAL END NOT VISIBLE ENDOSCOPICALLY. THE PHYSICIAN THEN PUNCTURED THE PLASTIC COVERING OF THE STENT WITH A HYDRA GUIDEWIRE, AND A WIRE GUIDED CANNULATION OF THE STENT WAS PERFORMED USING AN RX RETRIEVAL BALLOON CATHETER. THE STENT WAS OPACIFIED WITH CONTRAST, AND CONTRAST FLOWED INTO THE RIGHT AND LEFT INTRAHEPATIC DUCTS, INDICATING THAT THE PROXIMAL END OF THE STENT WAS IN A GOOD POSITION. AIR WAS ALSO VISIBLE IN THE INTRAHEPATIC DUCTS, INDICATING STENT PATENCY. ARGON PLASMA COAGULATION WAS USED TO CREATE A LARGE DEFECT IN THE INTRADUODENAL PORTION OF THE STENT TO ALLOW ADEQUATE BILIARY DRAINAGE. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS REPORTED. NO ISSUES WERE REPORTED WITH THE HYDRA GUIDEWIRE OR THE RX RETRIEVAL BALLOON CATHETER. ACCORDING TO THE COMPLAINANT, NO BLEEDING WAS NOTED DURING ANY OF THE ERCP'S. ON (B) (6) 2010, THE PATIENT EXPERIENCED BLEEDING AS EVIDENCED BY BLACK STOOLS AND WORSENING JAUNDICE. THE PATIENT WAS TREATED WITH BLOOD TRANSFUSIONS IN THE ICU. ON AN UNKNOWN DATE, THE PATIENT WENT HOME TO HOSPICE CARE AT THE FAMILY¿S REQUEST, AND DIED ON (B) (6) 2010. THE CAUSE OF DEATH WAS UNKNOWN, BUT THE PHYSICIAN ASSESSED AS POSSIBLY DUE TO BLEEDING AND POSSIBLY STENT PERFORATION RELATED. MFR#'S 3005099803-2010-00944, 3005099803-2010-01036, AND 3005099803-2010-00911 WERE CREATED TO REPORT ADDITIONAL DEVICES MENTIONED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - MIAMI UNK548

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| R RX RETRIEVAL BALLOON