BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICROVASIVE GOLD PROBE

    MDR report key: 1598102 · Received February 11, 2010

    Report

    Report Number
    3005099803-2010-00650
    Event Type
    Death
    Date Received
    February 11, 2010
    Report Date
    January 19, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    KNS
    PMA / PMN Number
    K970278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE 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. (B) (4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF SEVEN RELATED EVENTS. REFER TO MANUFACTURER REPORT # 3005099803-2010-00671, 3005099803-2010-00672, 3005099803-2010-00673, 3005099803-2010-00674 3005099803-2010-00675 AND 3005099803-2010-00676 FOR THE RELATED RESOLUTION CLIP DEVICE EVENTS. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B) (6) 2010, THAT SIX RESOLUTION CLIP DEVICES WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED ON (B) (6) 2009 AND TWO ADDITIONAL PROCEDURES PERFORMED ON SEPARATE DATES BETWEEN (B) (6) 2009 AND (B) (6) 2009. FOLLOW-UP WITH THE COMPLAINANT ON (B) (6) 2010 REVEALED THAT AN ADDITIONAL DEVICE (A GOLD PROBE ELECTROHEMOSTASIS CATHETER) WAS USED DURING ONE OF THESE PROCEDURES. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY WERE TREATING A BLEEDING ULCER IN THE DUODENUM. THEY USED A 2.8 MM CHANNEL GASTROSCOPE, WHICH IS THE MINIMUM WORKING CHANNEL SIZE. THEY WERE UNABLE TO ADVANCE THE DEVICE DOWN THE SCOPE DUE TO THE TORQUE IN THE SCOPE. THEY REMOVED THE DEVICE FROM THE SCOPE, TOOK THE SHEATH OFF AND THE RESOLUTION CLIP DEVICE WAS ADVANCED DOWN THE SCOPE AGAIN WITHOUT FURTHER COMPLICATIONS. LATER, (DATE UNKNOWN) THE PATIENT HAD TO BE BROUGHT BACK FOR TWO MORE PROCEDURES (ON DIFFERENT DAYS) AND IN BOTH PROCEDURES THE SHEATH HAD TO BE REMOVED TO ADVANCE THE DEVICE DOWN THE SCOPE. LATER (DATE UNKNOWN) THE PATIENT WAS BROUGHT TO SURGERY FOR A GI BLEED. THE PHYSICIAN USED A GOLD PROBE TO STOP THE BLEEDING BUT THE DEVICE WOULD NOT CAUTERIZE. THE COMPLAINANT BELIEVES THAT THE GENERATOR WAS FAULTY. THE PATIENT LATER PASSED AWAY (DATE UNKNOWN). THE COMPLAINANT CONFIRMED THAT THERE WERE NO DEFICIENCIES WITH THE RESOLUTION CLIP DEVICES OR THE GOLD PROBE DEVICE. IT WAS ONLY THE TORTUOSITY OF THE PATIENT'S ANATOMY THAT PREVENTED THE DEVICE FROM ADVANCING IN THE SCOPE. ONCE THE SHEATH WAS REMOVED THE DEVICE WAS ABLE TO ADVANCE DOWN THE SCOPE. IN ADDITION, THE NURSE REITERATED THAT THE PATIENT'S DEATH WAS NOT A RESULT OF THE RESOLUTION CLIP DEVICES OR THE GOLD PROBE DEVICE, BUT A RESULT OF THE PATIENT'S POOR HEALTH.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF SEVEN RELATED EVENTS. REFER TO MANUFACTURER REPORT # 3005099803-2010-00671, 3005099803-2010-00672, 3005099803-2010-00673, 3005099803-2010-00674 3005099803-2010-00675 AND 3005099803-2010-00676 FOR THE RELATED RESOLUTION CLIP DEVICE EVENTS. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 14, 2010, THAT SIX RESOLUTION CLIP DEVICES WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED ON (B) (6) 2009 AND TWO ADDITIONAL PROCEDURES PERFORMED ON SEPARATE DATES BETWEEN (B) (6) 2009 AND (B) (6) 2009. FOLLOW-UP WITH THE COMPLAINANT ON (B) (6) 2010 REVEALED THAT AN ADDITIONAL DEVICE (A GOLD PROBE ELECTROHEMOSTASIS CATHETER) WAS USED DURING ONE OF THESE PROCEDURES. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY WERE TREATING A BLEEDING ULCER IN THE DUODENUM. THEY USED A 2.8 MM CHANNEL GASTROSCOPE, WHICH IS THE MINIMUM WORKING CHANNEL SIZE. THEY WERE UNABLE TO ADVANCE THE DEVICE DOWN THE SCOPE DUE TO THE TORQUE IN THE SCOPE. THEY REMOVED THE DEVICE FROM THE SCOPE, TOOK THE SHEATH OFF AND THE RESOLUTION CLIP DEVICE WAS ADVANCED DOWN THE SCOPE AGAIN WITHOUT FURTHER COMPLICATIONS. LATER, (DATE UNKNOWN) THE PATIENT HAD TO BE BROUGHT BACK FOR TWO MORE PROCEDURES (ON DIFFERENT DAYS) AND IN BOTH PROCEDURES THE SHEATH HAD TO BE REMOVED TO ADVANCE THE DEVICE DOWN THE SCOPE. LATER (DATE UNKNOWN) THE PATIENT WAS BROUGHT TO SURGERY FOR A GI BLEED. THE PHYSICIAN USED A GOLD PROBE TO STOP THE BLEEDING BUT THE DEVICE WOULD NOT CAUTERIZE. THE COMPLAINANT BELIEVES THAT THE GENERATOR WAS FAULTY. THE PATIENT LATER PASSED AWAY (DATE UNKNOWN). THE COMPLAINANT CONFIRMED THAT THERE WERE NO DEFICIENCIES WITH THE RESOLUTION CLIP DEVICES OR THE GOLD PROBE DEVICE. IT WAS ONLY THE TORTUOSITY OF THE PATIENT'S ANATOMY THAT PREVENTED THE DEVICE FROM ADVANCING IN THE SCOPE. ONCE THE SHEATH WAS REMOVED, THE DEVICE WAS ABLE TO ADVANCE DOWN THE SCOPE. IN ADDITION, THE NURSE REITERATED THAT THE PATIENT'S DEATH WAS NOT A RESULT OF THE RESOLUTION CLIP DEVICES OR THE GOLD PROBE DEVICE, BUT A RESULT OF THE PATIENT'S POOR HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROVASIVE GOLD PROBE UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - MIAMI UNK163

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Death