BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DV8 ESOPHAGEAL RETRACTOR

    MDR report key: 7054648 · Received November 22, 2017

    Report

    Report Number
    3011596926-2017-00003
    Event Type
    Injury
    Date Received
    November 22, 2017
    Date of Event
    November 2, 2017
    Report Date
    November 22, 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

    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 WITH GENERAL ANESTHESIA ON (B)(6) 2017, THE PATIENT EXPERIENCED BLEEDING. UNINTERRUPTED ELIQUIS (5 MG TWICE DAILY) WAS GIVEN. THE DV8 DEVICE WAS EMPLOYED TO DISPLACE THE ESOPHAGUS TO THE RIGHT TO ALLOW BILATERAL PV ISOLATION; HOWEVER, IT WAS REPORTED THAT THE DEVICE WAS ADVANCED DEEPER, SO THAT INJECTION OF CONTRAST INTO THE PROXIMAL INJECTION PORT WOULD EXIT THE DISTAL ASPECT OF THE ESOPHAGUS. THE PATIENT REMAINED STABLE THROUGHOUT THE CASE. UPON COMPLETION OF THE CASE, THE DV8 DEVICE WAS REMOVED AND BLOOD-STAINED SECRETIONS WERE NOTED IN THE ORAL CAVITY. A NASOGASTRIC TUBE WAS INSERTED AND 150 CC OF BLOOD WAS ASPIRATED FROM THE STOMACH. INTRAVENOUS VASOPRESSORS AND FLUID RESUSCITATION WERE ADMINISTERED; THE PATIENT WAS IMMEDIATELY GIVEN 1 UNIT OF PACKED RED BLOOD CELLS AND STABILIZED. AN ENDOSCOPY WAS PERFORMED THAT DAY, BUT THE FINDINGS WERE POOR QUALITY. IT APPEARED THERE WAS AN AREA OF ULCERATION AND ACTIVE BLEEDING. A CT SCAN OF THE CHEST REVEALED NO EVIDENCE OF A PERFORATION. AS NO FURTHER INTERVENTION WAS PERFORMED THAT DAY, THE PATIENT WAS BROUGHT TO THE CARDIAC CARE UNIT. A REPEAT ENDOSCOPY WAS DONE THE FOLLOWING DAY, AND NO EVIDENCE OF ANY ESOPHAGEAL BLEEDING, TEARS OR TRAUMA WAS FOUND. THE STOMACH DID HAVE EVIDENCE OF TWO SUPERFICIAL LINEAR TEARS IN THE GASTRIC CARDIA FROM TRAUMA. MILD OOZING WITH A SMALL ADHERENT CLOT WAS NOTED. THE CLOT WAS REMOVED. THE PATIENT WAS THEN EXTUBATED AFTER THE SECOND ENDOSCOPY. THE PATIENT DID WELL AND WAS DISCHARGED ON POST-PROCEDURE DAY #2. IT WAS CONCLUDED THAT THE TRAUMA LIKELY OCCURRED AS A RESULT OF THE DISTAL PORTION OF THE DV8 DEVICE BEING INSERTED 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
    831487 DV8 ESOPHAGEAL RETRACTOR DV8 RETRACTOR GAD MANUAL SURGICAL SCIENCES, LLC 14075150

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R