BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DV8 ESOPHAGEAL RETRACTOR

    MDR report key: 7049172 · Received November 21, 2017

    Report

    Report Number
    3011596926-2017-00001
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    October 20, 2017
    Report Date
    November 17, 2017
    Manufacturer
    MANUAL SURGICAL SCIENCES, LLC
    Product Code
    GAD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE DV8 RETRACTOR IS A CLASS I 510K EXEMPT DEVICE UNDER PRODUCT CODE GAD (RETRACTOR) WHICH FALLS UNDER REGULATION 21 CFR 878.4800 AS A "MANUAL SURGICAL INSTRUMENT FOR GENERAL USE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON COMPLETION OF AN ATRIAL FIBRILLATION PROCEDURE ON (B)(6) 2017, THE PATIENT EXPERIENCED A BLEEDING ULCER. THE DV8 DEVICE WAS USED TO UNILATERALLY DEVIATE THE ESOPHAGUS TO THE PATIENTS RIGHT SIDE DURING THE PROCEDURE; IT WAS NOTED THAT THE DV8 DEVICE WAS ADVANCED DEEPER SO THAT THE INJECTION OF CONTRAST INTO THE PROXIMAL INJECTION PORT WOULD EXIT INTO THE DISTAL ASPECT OF THE ESOPHAGUS. THERE WAS MINIMAL INCREASED RESISTANCE TO THE ESOPHAGUS. DURING THE PROCEDURE, THE PATIENT ALSO UNDERWENT TEE IMAGING TO RULE OUT A THROMBUS. UPON COMPLETION OF THE PROCEDURE, THE DV8 DEVICE WAS REMOVED WITH NO EVIDENCE OF BLOOD, AND NO EVIDENCE OF BLOOD UPON SUCTIONING BY THE ANESTHESIA TEAM. THE PATIENT WAS EXTUBATED NORMALLY. THE PATIENT WAS RECOVERING AND FELT WELL THAT EVENING. HE RECEIVED A DOSE OF XARELTO THAT EVENING. THE PATIENT FELT WELL UNTIL THE NEXT MORNING AT 10:50 AM; HE EXPERIENCED NAUSEA AFTER BREAKFAST AND HAD HEMATEMESIS. HE THEN RECEIVED FLUID RESUSCITATION AND LATER BLOOD TRANSFUSIONS (4 PACKED RED BLOOD CELLS). ALL ANTICOAGULATION WAS HELD, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU), AND WAS ELECTIVELY INTUBATED IN ANTICIPATION OF AN ESOPHAGOGASTRODUODENOSCOPY (EGD). AN EGD PERFORMED THAT SAME DAY REVEALED A NORMAL ESOPHAGUS, BUT FOUND BLOOD CLOTS AND FOOD IN THE FUNDUS AND BODY. THE DUODENAL BULB WAS NORMAL. THERE WAS ALSO ACTIVE BLEEDING AT THE GASTROESOPHAGEAL JUNCTION FROM WHAT APPEARED TO BE A LINEAR ULCER. THE LESION WAS INJECTED WITH 6 CC OF 1:10,000 EPINEPHRINE. THE LESION WAS TREATED WITH BIPOLAR CAUTERY AND HEMOSTATIS WAS ACHIEVED. THE FINAL IMPRESSION OF THE EGD WAS AN ACTIVELY BLEEDING ULCER IN THE FUNDUS. THE PATIENT WAS EXTUBATED THE FOLLOWING DAY ((B)(6) 2017) AND TRANSFERRED OUT OF THE ICU 2 DAYS LATER ((B)(6) 2017). XARELTO WAS RESUMED THAT SAME DAY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2017. A CONCLUSION FROM.....STATED THAT THE CAUSE OF THE BLEEDING ULCER WAS THE GASTRIC FUNDUS OF THE STOMACH (IMPORTANTLY, THE STOMACH WAS NORMAL). THE CAUSE OF THIS ULCER WAS VERY LIKELY TRAUMATIC (THOUGH TIMING WAS UNUSUAL...I.E., NO BLEEDING DURING OR AFTER PROCEDURE, BUT RATHER STARTED THE NEXT DAY). THE CAUSE OF POTENTIAL TRAUMA COULD BE EITHER THE TEE PROBE OR THE DV8 DEVICE: THE TEE PROBE HAD BEEN INTRODUCED INTO THE STOMACH TO OBTAIN TRANSGASTRIC VIEWS OF THE VENTRICLE, AND THE DV8 DEVICE WHICH HAD BEEN ADVANCED PAST THE GE JUNCTION DEEPER INTO THE STOMACH. IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830389 DV8 ESOPHAGEAL RETRACTOR DV8 RETRACTOR GAD MANUAL SURGICAL SCIENCES, LLC 14075150

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R TEE PROBE