BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOFLIP

    MDR report key: 8370943 · Received February 26, 2019

    Report

    Report Number
    3006897778-2019-00001
    Event Type
    Injury
    Date Received
    February 26, 2019
    Date of Event
    January 28, 2019
    Report Date
    September 24, 2019
    Manufacturer
    CROSPON LTD
    Product Code
    PIE
    PMA / PMN Number
    K132337
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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 · 0

    MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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, THE PATIENT'S ESOPHAGUS WAS PERFORATED DURING THE PROCEDURE FOR DIAGNOSTIC/DILATION. IT WAS NOTED THAT EGD (ESOPHAGOGASTRODUODENOSCOPY) DID NOT SHOW VERY TIGHT LES (LOWER ESOPHAGEAL SPHINCTER). THE CATHETER WAS INSERTED AND SHOWED DI 0.3-0.5. THE PHYSICIAN WAS CONFUSED, AS THE NUMBERS DID NOT MATCH WHAT WAS SEEN ON EGD OR BARIUM SWALLOW. THE PHYSICIAN WANTED TO DO EMPIRIC DILATION BECAUSE THE PATIENT WAS SYMPTOMATIC, A TYPICAL CHEST PAIN AFTER EATING. DILATION WENT OKAY WITH THE DILATION CATHETER ¿ 60CC, 24.4CM. THERE WAS NO SCOPE DURING DILATION AND AFTER, THE SCOPE WAS INSERTED AND DID NOT SEE OBVIOUS PERFORATION, BUT IT SAW A GOOD AMOUNT OF BLEEDING THAT WAS MORE THAN USUAL. THE PATIENT DID WELL AFTER, HAD A MILD CHEST DISCOMFORT AND WENT HOME. THE NEXT DAY, THE PATIENT EXPERIENCED MORE CHEST PAIN, LEFT CHEST, GOT BARIUM SWALLOW, NOT DEFINITIVE FOR PERFORATION. A CT SCAN ON THE NEXT DAY SHOWED EXTRAVASATION OF CONTRAST (LEAK). THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR 2 WEEKS ON ANTIBIOTICS AND NPO (NOTHING BY MOUTH) FOR FEW DAYS. A REPEAT CT SCAN STILL SHOWED LEAK, SO PATIENT WAS PUT IN ESOPHAGEAL STENT. THE ENDOSCOPIST AT THAT TIME STATED THAT THE TEAR LOOKED TO BE 7CM, BUT THE PHYSICIAN DID NOT BELIEVE IT WAS THAT BIG OR ELSE THE PATIENT WOULD HAVE BEEN MUCH MORE SYMPTOMATIC. ANOTHER REPEAT CT/BARIUM SHOWED NO LEAK, SO THE PATIENT WENT ON ADVANCE DIET AND WENT HOME AFTER 2 WEEKS. THE PATIENT HAD RETCHING/VOMITING, SO THE TEAR MIGHT HAVE GOTTEN LARGER DUE TO THAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165928 ESOFLIP ESOPHAGEAL DILATOR WITH BALLOON AND ELECTRODE SENSORS PIE CROSPON LTD ES-330

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention