BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRUETOME JAG 39

    MDR report key: 7840527 · Received September 3, 2018

    Report

    Report Number
    3005099803-2018-60232
    Event Type
    Death
    Date Received
    September 3, 2018
    Date of Event
    August 2, 2018
    Report Date
    September 1, 2018
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K122203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT PATIENT AGE IS UNKNOWN; HOWEVER, SHE WAS REPORTED TO BE IN HER 70'S. THE EXACT DATE OF DEATH WAS NOT PROVIDED, BUT IT WAS REPORTED TO BE BEFORE SUNDAY (B)(6) 2018. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 39 SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR STONE REMOVAL PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, AFTER GAINING ACCESS TO THE DUCT WITH A GUIDEWIRE, THE TRUETOME DEVICE WAS USED FOR ENDOSCOPIC SPHINCTEROTOMY (EST) AT THE AMPULLA. INCIDENTALLY, THE PHYSICIAN COMMENTED THAT HE DID NOT LIKE THAT THE DEVICE USED A "SHORT-WIRE" GUIDEWIRE SYSTEM; HE PREFERS LONG-WIRE. THE PATIENT HAD A DIVERTICULUM NEAR THE AMPULLA. DESPITE THIS, THE PHYSICIAN PERFORMED THE SPHINCTEROTOMY PROCEDURE. DURING SPHINCTEROTOMY, THE PHYSICIAN CUT INTO AN ARTERY NEAR THE DIVERTICULUM WHICH RESULTED IN HEMORRHAGE. THE PHYSICIAN PERFORMED SUCTION, APPLIED EPINEPHRINE, AND REPEATEDLY FLUSHED THE SITE TO STAUNCH THE BLEED, BUT NO CLIPPING OR OTHER ESCALATED MEASURES WERE PERFORMED TO ACHIEVE HEMOSTASIS. REPORTEDLY, THE BLEED SLOWED ENOUGH TO CONTINUE WITH THE PROCEDURE. AFTER SPHINCTEROTOMY, A BALLOON SWEEP WAS PERFORMED FOR STONE REMOVAL AND A PLASTIC STENT WAS PLACED FOR BILIARY DRAINAGE. REPORTEDLY, THE PHYSICIAN BELIEVED HE HAD DONE ENOUGH TO ACHIEVE HEMOSTASIS DURING THE PROCEDURE, AND AT THE END OF THE PROCEDURE THE PHYSICIAN INDICATED HE BELIEVED THERE TO BE NO COMPLICATIONS. HOWEVER, AT SOME POINT POST-PROCEDURE (TIME UNKNOWN), THE PATIENT EXPERIENCED BLOOD LOSS PER RECTUM. ON (B)(6) 2018 (THE DAY FOLLOWING THE PROCEDURE) AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WAS PERFORMED BY THE PHYSICIAN TO ASSESS THE BLEED. THE RESULTS OF THIS ASSESSMENT, AND ANY ACTIONS TAKEN, ARE UNKNOWN. THE PATIENT LATER PASSED AWAY. THE EXACT DATE OF THE PATIENT'S DEATH WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE PATIENT PASSED AWAY SOME TIME BEFORE (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681741 TRUETOME JAG 39 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION UNK-P-TRUETOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R