BEUDAMED
    FDA Adverse Event Death Summary report: N

    JAGWIRE

    MDR report key: 2013167 · Received March 10, 2011

    Report

    Report Number
    3005099803-2011-00693
    Event Type
    Death
    Date Received
    March 10, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) OF AGE; EXACT AGE IS UNKNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF 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.

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS ONE OF THREE DEVICES THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2011-00645, MFR REPORT # 3005099803-2011-00693 AND MFR REPORT# 3005099803-2011-00694). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ON (B)(6), 2011 A TANDEM RX ERCP CANNULA, A JAGWIRE GUIDEWIRE AND A WALLFLEX ENTERAL DUODENAL STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) TO PLACE A STENT IN A PATIENT WITH PANCREATIC CANCER. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD SIGNS OF A PERFORATION PRIOR TO THIS PROCEDURE. THE CAUSE OF THE PRE-EXISTING PERFORATION IS UNKNOWN. DURING THE PROCEDURE ON (B)(6), 2011, THE PHYSICIAN COULD NOT ADVANCE THE SCOPE THROUGH THE STRICTURE, SO A TANDEM RX CANNULA WAS PASSED THROUGH THE STRICTURE. IT WAS DETERMINED BY ERCP THAT THE SIZE OF THE STRICTURE WAS 4 OR 5 CM FROM THE SECOND PORTION OF THE DUODENA TO THE HORIZONTAL PART OF THE DUODENUM. THE PHYSICIAN THEN INSERTED THE JAGWIRE GUIDEWIRE INTO THE LIGAMENT OF TREITZ AND ADVANCED THE WALLFLEX INTO THE PATIENT. WHEN THE DELIVERY SYSTEM OF THE STENT CAME OUT FROM THE TIP OF THE SCOPE, THE PATIENT BECAME VIOLENT AND VOMITED. THE PHYSICIAN MANAGED TO DEPLOY THE STENT AND NOTED FREE AIR INSIDE THE PATIENT. A DRAINAGE TUBE WAS PLACED TO TREAT THE PERFORATION. IT SHOULD BE NOTED THAT THERE WAS NO RESISTANCE ADVANCING THE GUIDEWIRE OR THE CANNULA INTO THE PATIENT AND THE PHYSICIAN REPORTED THAT THERE WERE NO ISSUES OR MALFUNCTIONS WITH THE CANNULA, GUIDEWIRE OR STENT. THE PATIENT SUBSEQUENTLY PASSED AWAY ON (B)(6), 2011. ALTHOUGH THE PHYSICIAN COULD NOT SPECIFY THE CAUSE OF DEATH, IT WAS REPORTED THAT NONE OF THE DEVICES INVOLVED IN THIS PROCEDURE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. DESPITE THE PHYSICIAN'S ASSESSMENT, BOSTON SCIENTIFIC IS REPORTING THIS EVENT BASED ON THE POSSIBILITY THAT THE ABOVE DEVICES MADE THE PRE-EXISTING PERFORATION WORSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA M00556611 13892539

    Patients

    Seq Age Sex Outcome Treatment
    1 Death (B)(4)