BEUDAMED
    FDA Adverse Event Death Summary report: N

    DREAMWIRE¿

    MDR report key: 7152005 · Received December 28, 2017

    Report

    Report Number
    3005099803-2017-03989
    Event Type
    Death
    Date Received
    December 28, 2017
    Date of Event
    November 23, 2017
    Report Date
    December 4, 2017
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    UDI-DI
    08714729777861
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DEATH DATE IS UNKNOWN BUT IT WAS REPORTED THAT THE PATIENT DIED 48 HOURS AGO AFTER THIS COMPLAINT HAS BEEN REPORTED. DEVICE PROBLEM CODE RELATES TO THE DEVICE COMPONENT CODE FOR THE REPORTED EVENT OF CORE WIRE BROKEN. 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

    CORRECTION: DESCRIBE EVENT OR PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMWIRE WAS USED IN THE BILE DUCT AND DUODENUM DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS PERFORMED DUE TO STENOSIS OF THE BILE DUCT AND DUODENUM WHICH DOES NOT ALLOW DRAINAGE OF BILE DUCTS BY RETROGRADE APPROACH. DURING THE PROCEDURE, TO ADDRESS THE DRAINAGE PROBLEM, TRANSHEPATIC ECHO-ENDOSCOPIC CONTROL APPROACH WAS PERFORMED. THE DREAMWIRE GUIDEWIRE WAS INSERTED FIRST, AND THEN A NON-BSC ASPIRATION NEEDLE WITH 19GEZ SHOT WAS THEN PLACED. IT WAS NOTICED THAT THE GUIDEWIRE PEELED WITH THE NEEDLE, LEADING TO THE BLOCKAGE OF THE GUIDEWIRE. THE OUTER SHEATH OF THE GUIDEWIRE BROKE AND STUCK INSIDE THE CYSTOSTOME. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT, WHICH WAS REPORTEDLY RISK FOR BILIARY FISTULA. THE PATIENT WAS TREATED WITH ANTIBIOTIC DUE TO DRAINAGE FAILURE. 5 DAYS LATER, THE PATIENT HAD BILE IN THE PERITONEUM THRU EXPLORATORY LAPAROTOMY. THE PATIENT WAS TRANSFERRED TO A DIFFERENT FACILITY AS THE PATIENT HAD CARDIAC ARREST. ACTIONS TAKEN FOR THE PATIENT CONCERNING THE MEDICAL DEVICE: CLOSE MONITORING AND CONTINUOUS CARE ACTIONS TAKEN IN THE HOSPITAL: CHANGE OF THE GUIDEWIRE (SIZE 0.025) FOR THE NEXT PROCEDURES REPORTEDLY, THE PATIENT DIED AND THE EXACT DATE OF DEATH IS UNKNOWN. THE CAUSE OF DEATH IS UNKNOWN AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMWIRE WAS USED IN THE BILE DUCT AND DUODENUM DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS PERFORMED DUE TO STENOSIS OF THE BILE DUCT AND DUODENUM WHICH DOES NOT ALLOW DRAINAGE OF BILE DUCTS BY RETROGRADE APPROACH. DURING THE PROCEDURE, TO ADDRESS THE DRAINAGE PROBLEM, TRANSHEPATIC ECHO-ENDOSCOPIC CONTROL APPROACH WAS PERFORMED. THE DREAMWIRE GUIDEWIRE WAS INSERTED FIRST, AND THEN A NON-BSC ASPIRATION NEEDLE WITH 19GEZ SHOT WAS THEN PLACED. IT WAS NOTICED THAT THE GUIDEWIRE PEELED WITH THE NEEDLE, LEADING TO THE BLOCKAGE OF THE GUIDEWIRE. THE OUTER SHEATH OF THE GUIDEWIRE BROKE AND STUCK INSIDE THE CYSTOSTOME. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT, WHICH WAS REPORTEDLY RISK FOR BILIARY FISTULA. THE PATIENT WAS TREATED WITH ANTIBIOTIC DUE TO DRAINAGE FAILURE. 5 DAYS LATER, THE PATIENT HAD BILE IN THE PERITONEUM THRU EXPLORATORY LAPAROTOMY. THE PATIENT WAS TRANSFERRED TO A DIFFERENT FACILITY AS THE PATIENT HAD CARDIAC ARREST. ACTIONS TAKEN FOR THE PATIENT CONCERNING THE MEDICAL DEVICE: CLOSE MONITORING AND CONTINUOUS CARE ACTIONS TAKEN IN THE HOSPITAL: CHANGE OF THE GUIDEWIRE (SIZE 0.025) FOR THE NEXT PROCEDURES. REPORTEDLY, THE PATIENT DIED AND THE EXACT DATE OF DEATH IS UNKNOWN. THE CAUSE OF DEATH IS UNKNOWN AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ***CORRECTION AS OF DECEMBER 13, 2017.*** AS THE PHYSICIAN PERFORMED HEPATICOGASTRIC DRAINAGE ON (B)(6) 2017, THE OUTER SHEATH OF THE GUIDEWIRE BROKE AND WAS STUCK INSIDE THE CYSTOSTOME, REPORTEDLY IT WAS IMPOSSIBLE TO EXTRACT. THE PHYSICIAN PERFORMED ANASTOMOSIS, AND REMOVED EVERYTHING. IT WAS REPORTED THAT AFTER THIS THE PATIENT DIED 48 HOURS AGO (THE EXACT DATE IS UNKNOWN.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932633 DREAMWIRE¿ STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00556161 20980109 08714729777861

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death