BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 5178232 · Received October 26, 2015

    Report

    Report Number
    2951250-2015-01244
    Event Type
    Malfunction
    Date Received
    October 26, 2015
    Report Date
    January 20, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DATA CORRECTION: THE PRODUCT CODE KNH WAS REPLACED WITH HHS.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP RECEIVED ON 21-MAR-2016: FOLLOW-UP ATTEMPTS WERE PERFORMED WITH NO RESPONSE TO DATE. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS MEDICALLY CONFIRMED CASE REPORT REFERS TO A FEMALE PATIENT WHO WAS HAVING ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND THE DEVICE BROKE OFF INSIDE HER DURING THE PROCEDURE. THIS EVENT WAS CONSIDERED ANTICIPATED ACCORDING TO THE TECHNICAL ANALYSIS. DURING DIFFICULT INSERTIONS, SINGLE CASES OF DEVICE BREAKAGE HAVE BEEN REPORTED. IN THE PRESENT CASE LIMITED INFORMATION WAS PROVIDED. HOWEVER, SINCE THE BREAKAGE OCCURRED DURING THE ESSURE INSERTION PROCEDURE, CAUSALITY WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS OTHER REPORTABLE INCIDENT, AS ALTHOUGH THE REPORTED DEVICE BREAKAGE DID NOT LEAD TO DEATH OR SERIOUS HEALTH DETERIORATION THIS MIGHT HAVE OCCURRED UNDER LESS FORTUNATE CIRCUMSTANCES. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP TO A QUALITY DEFECT. DESPITE FOLLOW UP ATTEMPTS, NO FURTHER INFORMATION WAS OBTAINED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP WAS RECEIVED ON 23-OCT-2015 WITH NO NEW INFORMATION, AND THE PRODUCT TECHNICAL COMPLAINT (PTC) INVESTIGATION RESULT WAS RECEIVED ON 31-OCT-2015, REFERRING TO PTC GLOBAL NUMBER (B)(4): FINAL ASSESSMENT: FAILURE MODE/MECHANISM: THE ESSURE INSERT IS MADE UP OF A FLEXIBLE OUTER COIL THAT IS DEPLOYED INTO THE FALLOPIAN TUBE. THE INSERT'S OUTER COILS EXPAND TO CONFORM TO THE FALLOPIAN TUBE, ACUTELY ANCHORING ITSELF UNTIL THE INSERT ELICITS TISSUE INGROWTH. AFTER THE FIRST ROLL BACK IS COMPLETED AND THE BUTTON IS PRESSED, USER ATTEMPTS TO REPOSITION THE DEVICE COULD LEAD TO DETACHMENT DIFFICULTY, PREMATURE DEPLOYMENT, OR IMPROPER DEVICE FUNCTION. IF ALL INSTRUCTIONS STEPS HAVE NOT BEEN COMPLETED, USER ATTEMPTS TO REPOSITION OR REMOVE THE CATHETER ASSEMBLY COULD LEAD TO EITHER A STRETCHING OR BREAKAGE OF THE MICRO-INSERT OR A PART OF THE CATHETER. IF THE PHYSICIAN ATTEMPTS TO REMOVE A DEPLOYED MICRO-INSERT THAT IS LOCATED WITHIN THE FALLOPIAN TUBE BY PULLING ON THE OUTER COIL OF THE MICRO-INSERT WITH A GRASPER, THIS ACTION COULD ALSO LEAD TO BREAKAGE OF THE OUTER COIL OF THE MICRO-INSERT. FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. FOR CASES WHERE AN INSERT IS REMOVED AT A LATER TIME AFTER INSERTION, WE TYPICALLY DO NOT CONDUCT AN INSPECTION OF THE INSERT. IN THIS CASE, NO PRODUCT WAS RETURNED. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE WERE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. THE POSSIBILITY OF MICRO-INSERT BREAKING IS AN ANTICIPATED EVENT AND THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A REPORTED TECHNICAL PRODUCT ISSUE. HOWEVER, NO MEDICAL EVENTS WERE REPORTED. SINCE NO MEDICAL EVENTS AND NO BATCH NUMBER WERE REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR ADVERSE EVENTS ADVERSE EVENT CASES IS NOT APPLICABLE. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP TO A QUALITY DEFECT. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS MEDICALLY CONFIRMED CASE REPORT REFERS TO A FEMALE PATIENT WHO WAS HAVING ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND THE DEVICE BROKE OFF INSIDE HER DURING THE PROCEDURE. THIS EVENT WAS CONSIDERED ANTICIPATED ACCORDING TO THE TECHNICAL ANALYSIS. DURING DIFFICULT INSERTIONS, SINGLE CASES OF DEVICE BREAKAGE HAVE BEEN REPORTED. IN THE PRESENT CASE LIMITED INFORMATION WAS PROVIDED. HOWEVER, SINCE THE BREAKAGE OCCURRED DURING THE ESSURE INSERTION PROCEDURE, CAUSALITY WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS OTHER REPORTABLE INCIDENT, AS ALTHOUGH THE REPORTED DEVICE BREAKAGE DID NOT LEAD TO DEATH OR SERIOUS HEALTH DETERIORATION THIS MIGHT HAVE OCCURRED UNDER LESS FORTUNATE CIRCUMSTANCES. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP TO A QUALITY DEFECT. FURTHER INFORMATION IS EXPECTED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A NURSE IN UNITED STATES ON 29-SEP-2015 WHICH REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO WAS HAVING ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON AN UNSPECIFIED DATE. WHEN ATTEMPTING TO INSERT ESSURE DEVICE IT BROKE OFF INSIDE THE PATIENT. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS MEDICALLY CONFIRMED CASE REPORT REFERS TO A FEMALE PATIENT WHO WAS HAVING ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND THE DEVICE BROKE OFF INSIDE THE PATIENT DURING THE PROCEDURE. THIS EVENT IS NON-SERIOUS AND UNLISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. DURING DIFFICULT INSERTIONS, SINGLE CASES OF DEVICE BREAKAGE HAVE BEEN REPORTED. IN THE PRESENT CASE LIMITED INFORMATION WAS PROVIDED. HOWEVER, SINCE THE BREAKAGE OCCURRED DURING THE ESSURE INSERTION PROCEDURE, CAUSALITY WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS OTHER REPORTABLE INCIDENT, AS ALTHOUGH THE REPORTED DEVICE BREAKAGE DID NOT LEAD TO DEATH OR SERIOUS HEALTH DETERIORATION THIS MIGHT HAVE OCCURRED UNDER LESS FORTUNATE CIRCUMSTANCES. A PRODUCT TECHNICAL ANALYSIS AND FURTHER INFORMATION ARE EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708410 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1