BEUDAMED
    FDA Adverse Event Death Summary report: N

    DREAMTOME¿ RX 44

    MDR report key: 3002921 · Received March 13, 2013

    Report

    Report Number
    3005099803-2013-01766
    Event Type
    Death
    Date Received
    March 13, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT: CATHETER LEAK. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED; THEREFORE A PHYSICAL EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A LABELING REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE DETERMINATION OF A ROOT CAUSE COULD NOT BE COMPLETED WITHOUT ANALYSIS OF THE DEVICE INVOLVED; THEREFORE, THE MOST PROBABLE ROOT CAUSE OF THE EVENT IS UNDETERMINABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME WAS USED DURING A PROCEDURE FOR "RETROGRADE CATHETERIZATION OF THE PAPILLA" PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER THE DEVICE WAS INSERTED INTO THE PAPILLA AND SALINE WAS INJECTED, "IT WAS DIFFICULTY TO OPACIFY THE CHOLEDUCT." A LEAK WAS FOUND IN THE DEVICE APPROXIMATELY 4 CM FROM THE DISTAL TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED PANCREATITIS AND WAS TRANSFERRED TO ANOTHER FACILITY FOR CARE IN THE ICU. IT WAS LATER REPORTED THAT THE PATIENT DIED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN MADE. WE ARE WAITING FOR CLARIFICATION REGARDING THE RELATIONSHIP OF THE DEVICE TO THE PATIENT OUTCOME. WHEN ADDITIONAL INFORMATION IS OBTAINED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED. ON (B)(6) 2013 RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE COMPLAINANT. ACCORDING TO THE PHYSICIAN, PRIOR TO THE PROCEDURE, THE PATIENT PRESENTED WITH ANEMIA. A COLONOSCOPY WAS PLANNED TO DETERMINE THE CAUSE OF THE ANEMIA, HOWEVER, THE PROCEDURE WAS NOT INITIATED SINCE THE PATIENT HAD A HERNIA. IN ADDITION, THE PATIENT HAD CHOLESTASIS AND DILATION OF THE BILIARY DUCT. AN ULTRASOUND WAS COMPLETED HOWEVER, THE IMAGES WERE NOT SUFFICIENT TO DETERMINE IF THE ANEMIA WAS CAUSED BY KIDNEY STONES OR CANCER. THEREFORE, THE PHYSICIAN PLANNED A RETROGRADE CATHETERIZATION OF THE PAPILLA FOR REMOVAL OF KIDNEY STONES. THE PHYSICIAN THEN ATTEMPTED A SPHINCTEROTOMY OF THE COMMON HEPATIC DUCT. SINCE THE PATIENT WAS LYING ON HIS SIDE, THE "OPACIFICATION WAS DIFFICULT" AND THE SPHINCTEROTOMY WAS INADVERTENTLY PERFORMED ON THE PANCREATIC DUCT INSTEAD OF THE COMMON HEPATIC DUCT. THE DEVICE WAS REMOVED FROM THE PATIENT, AND IT APPEARED THAT THE DREAMTOME WAS LEAKING APPROXIMATELY 4 CM FROM THE DISTAL TIP (1 CM PROXIMAL TO THE CUTTING WIRE). ANOTHER SPHINCTEROTOMY WAS PERFORMED ON THE BILIARY DUCT, AND BILIARY SLUDGE WAS REMOVED. PROCEDURE TIME WAS INCREASED DUE TO THIS ISSUE. THE PATIENT IMMEDIATELY RECEIVED ANTIBIOTIC TREATMENT AND WAS MONITORED THAT SAME DAY. ACCORDING TO THE PHYSICIAN THE PATIENT SPENT A "GOOD NIGHT UNDER MONITORING". HOWEVER, THE DAY FOLLOWING THE PROCEDURE, HIS STATUS DRAMATICALLY DECLINED. THE PATIENT WAS DIAGNOSED WITH PANCREATITIS, AND TRANSFERRED TO ANOTHER HOSPITAL IN (B)(6), WHERE THE DEATH OCCURRED ON AN UNKNOWN DATE. ACCORDING TO THE PHYSICIAN, THE CAUSE OF DEATH WAS ACUTE PANCREATITIS. NO AUTOPSY HAS BEEN PERFORMED TO THE PHYSICIAN'S KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME WAS USED DURING A PROCEDURE FOR "RETROGRADE CATHETERIZATION OF THE PAPILLA" PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER THE DEVICE WAS INSERTED INTO THE PAPILLA AND SALINE WAS INJECTED, "IT WAS DIFFICULTY TO OPACIFY THE CHOLEDUCT." A LEAK WAS FOUND IN THE DEVICE APPROXIMATELY 4 CM FROM THE DISTAL TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED PANCREATITIS AND WAS TRANSFERRED TO ANOTHER FACILITY FOR CARE IN THE ICU. IT WAS LATER REPORTED THAT THE PATIENT DIED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN MADE. WE ARE WAITING FOR CLARIFICATION REGARDING THE RELATIONSHIP OF THE DEVICE TO THE PATIENT OUTCOME. WHEN ADDITIONAL INFORMATION IS OBTAINED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104815 DREAMTOME¿ RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00584050 15600600

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| H