BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DV8 ESOPHAGEAL RETRACTOR

    MDR report key: 7172554 · Received January 8, 2018

    Report

    Report Number
    3011596926-2018-00001
    Event Type
    Injury
    Date Received
    January 8, 2018
    Date of Event
    December 12, 2017
    Report Date
    January 8, 2018
    Manufacturer
    MANUAL SURGICAL SCIENCES
    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

    THE DV8 RETRACTOR IS A CLASS I 510(K) 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, THE PATIENT EXPERIENCED SIGNIFICANT EPISTAXIS. THE DV8 RETRACTOR WAS USED AS NORMAL AND WITHOUT INCIDENT TO DISPLACE THE ESOPHAGUS TO THE RIGHT TO ALLOW LEFT PV ISOLATION. PER USUAL CLINICAL PRACTICE, THE PROCEDURE WAS PERFORMED WITH UNINTERRUPTED ELIQUIS (5 MG TWICE DAILY) UNDER GENERAL ANESTHESIA. DURING THE CONTRALATERAL ATTEMPT WITH THE DV8 RETRACTOR (TO THE LEFT FOR RIGHT PV ISOLATION), THE ESOPHAGUS FAILED TO DEVIATE FROM THE MIDLINE IN A SIGNIFICANT DEGREE. THERE APPEARED TO BE RESISTANCE TO DEVIATION. NEAR THE END OF THE PROCEDURE, THE PATIENT WAS NOTED TO HAVE SIGNIFICANT EPISTAXIS. EAR NOSE AND THROAT WAS URGENTLY CONSULTED. NO TRAUMA WAS NOTED IN THE NASOPHARYNX OR OROPHARYNX. GASTROENTEROLOGY WAS CONSULTED AND AN ENDOSCOPY WAS PERFORMED. MULTIPLE SMALL SUBMUCOSAL ESOPHAGEAL BLEBS WERE NOTED IN THE ESOPHAGUS. A MEDIUM SIZED BLEB WITH A LOCALIZED DISTRIBUTION WAS FOUND IN THE UPPER THIRD OF THE ESOPHAGUS WITH AN ADJACENT SUPERFICIAL MUCOSAL TEAR THAT WAS ACTIVELY OOZING. THE TISSUE EDGES WERE APPROXIMATED AND TWO HEMOSTATIC CLIPS WERE PLACED TO REPAIR THE DEFECT. THIS WAS NOTED TO BE SUCCESSFUL, AND THERE WAS NO BLEEDING AT THE END OF THE PROCEDURE. THE STOMACH AND DUODENUM WERE EXAMINED AND FOUND TO BE NORMAL. THE GASTROENTEROLOGIST FELT THAT THE TRAUMA/BLEBS WERE MOST CONSISTENT WITH PRESSURE NECROSIS. THE PATIENT WAS TRANSFERRED TO THE CARDIAC CARE UNIT AND REMAINED INTUBATED OVERNIGHT; THE PATIENT WAS EXTUBATED THE FOLLOWING DAY. THE PATIENT RECEIVED ONE UNIT OF PACKED RED BLOOD CELLS. THE PATIENT DID WELL AND WAS DISCHARGED ON (B)(6) 2017. IT WAS NOTED THAT THE PRESSURE OF THE DV8 BALLOON AGAINST THE "POORLY/NON MOVING" ESOPHAGUS LIKELY CAUSED THE PRESSURE NECROSIS. IT WAS ALSO THOUGHT THAT THE IV HEPARIN (ACT >350) AND UNINTERRUPTED OAC DURING THE PROCEDURE, THE PRESSURE CAUSED THE BLEBS AND RESULTED IN THE BLEEDING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15485 DV8 ESOPHAGEAL RETRACTOR DV8 RETRACTOR GAD MANUAL SURGICAL SCIENCES 14075150

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention