BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOFLIP

    MDR report key: 8452525 · Received March 26, 2019

    Report

    Report Number
    3006897778-2019-00004
    Event Type
    Injury
    Date Received
    March 26, 2019
    Date of Event
    January 14, 2019
    Report Date
    September 25, 2019
    Manufacturer
    CROSPON LTD
    Product Code
    PIE
    PMA / PMN Number
    K132337
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THEY HAD A PATIENT WITH HISTORY OF ACHALASIA AND FINDINGS OF ESOPHAGEAL SPASMING AND STRICTURING. FIRST DILATION OF THE PATIENT WAS UP TO MID TWENTIES AND AFTER THIS DILATION, THE DIAMETER WAS ROUGHLY 10 OR 12. EVENTUALLY, THEY GOT TO 30 AFTER WHICH THE RESTING DIAMETER WAS ABOUT 16. THERE HAD BEEN A RELATIVELY LITTLE AMOUNT OF MUCOSAL TRAUMA BEFORE THE 30 DILATION THAT WENT MORE SO THAT WOULD TYPICALLY HAVE BEEN EXPECTED. THE PATIENT WAS SENT FOR A CHEMICAL STUDY WHICH DID NOT SHOW PERFORATION AND AFTER THIS, A CHEST CT SCAN WAS EVENTUALLY PERFORMED AND SHOWED NO OBVIOUS ESOPHAGEAL LEAKAGE. A REPEAT CHEMICAL STUDY WAS PERFORMED WHICH EVENTUALLY SHOWED A LEAK AND AFTER THE RESULT, THE PATIENT WENT TO THE OPERATING ROOM FOR THE REPAIR OF THE TEAR IN THE ESOPHAGUS FROM THE DILATION. THE PATIENT WAS HOSPITALIZED FOR APPROXIMATELY 10 DAYS. NO REPEAT PROCEDURE WAS NECESSARY AND THE PATIENT'S LAST KNOWN STATUS WAS OK AND DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243916 ESOFLIP ESOPHAGEAL DILATOR WITH BALLOON AND ELECTRODE SENSORS PIE CROSPON LTD ES-330

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention