BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOTOME? RX 44

    MDR report key: 3811326 · Received May 15, 2014

    Report

    Report Number
    3005099803-2014-01881
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 15, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBERS 3005099803-2014-01880 AND 3005099803-2014-01881. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, PRIOR TO THE PROCEDURE, THE PATIENT WAS NOTED TO HAVE ELEVATED LIVER ENZYME LEVELS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED CANNULATION OF THE COMMON BILE DUCT SUCCESSFULLY USING A HYDRAJAGWIRE . CONTRAST MEDIUM WAS NOT USED, AND THE WIRE DID NOT ENTER THE PANCREATIC DUCT. AN AUTOTOME WAS THEN ADVANCED INTO THE PATIENT AND THE PHYSICIAN FOUND THAT THE AUTOTOME WAS NOT BOWING ¿TO ITS NORMAL AMOUNT¿. A SECOND AUTOTOME WAS THEN USED TO PERFORM A SPHINCTEROTOMY OF THE PAPILLA. IT WAS REPORTED THAT THE PHYSICIAN DID NOT CUT AS FAR AS USUAL, MAKING AN UNUSUALLY SMALL SPHINCTEROTOMY. THERE WERE NO ISSUES NOTED WITH THE SECOND AUTOTOME AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED PANCREATITIS AND WAS HOSPITALIZED. THE PATIENTS ENZYMES WERE REPORTED TO BE DROPPING BACK TOWARDS NORMAL LEVELS AND THE PATIENT¿S CONDITION IS STABLE. THERE WERE NO KNOWN DEVICE ISSUES DIRECTLY RELATED TO THE PATIENT¿S POST-PROCEDURE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291142 AUTOTOME? RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00545170 16633807

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization