BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM TTC BILIARY BALLOON DILATOR

    MDR report key: 14105659 · Received April 13, 2022

    Report

    Report Number
    1037905-2022-00185
    Event Type
    Malfunction
    Date Received
    April 13, 2022
    Report Date
    April 13, 2022
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FGE
    PMA / PMN Number
    K171223
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS ON GOING. A FOLLOW UP REPORT WILL BE SENT TO CAPTURE THE COMPLETED INVESTIGATION.

    Additional Manufacturer Narrative · 0

    AN EMDR REPORT WAS INITIALLY SENT ON 13 APRIL 2022, BASED ON THE INFORMATION PUBLISHED IN THE CLINICAL LITERATURE REFERENCED. HOWEVER, UPON FURTHER INVESTIGATION INTO THE EVENT, IT WAS DETERMINED THAT THIS HAD BEEN PREVIOUSLY REPORTED UNDER 1037905-2019-00137. THIS IS A DUPLICATE REPORT AND THIS FOLLOW UP IS BEING SENT TO CANCEL THE INITIAL EMDR.

    Description of Event or Problem · 0

    THERE ARE TWO LITERATURE ARTICLES INVOLVING COOK QUANTUM DILATION BALLOONS, PUBLISHED BY THE SAME AUTHORS, WITH THE OVERLAPPING TIME FRAMES, SAME TECHNIQUES PERFORMED TO TREAT THE SAME ISSUE, AT THE SAME FACILITY. WHILE THE AIMS OF THE ARTICLES ARE DIFFERENT, THE DATA SET IS LARGELY OVERLAPPING (ONE ARTICLE IS A SUBSET OF DATA WITHIN THE OTHER ARTICLE'S TIME FRAME). IT IS REASONABLE TO CONCLUDE THAT THIS IS THE SAME PATIENT. THEREFORE, ONE EMDR IS BEING SENT TO CAPTURE THE 1 DEVICE RELATED ADVERSE EVENT WITH THE SAME TREATMENT PUBLISHED IN BOTH ARTICLES. DURING BALLOON DILATION WITH EITHER A COOK QUANTUM BALLOON DILATOR OR A REN BALLOON DILATOR, 1 PATIENT EXPERIENCED BILE DUCT END LACERATION CAUSED BY EXCESSIVE BALLOON DILATION TO A SIZE LARGER THAN THE IHBD END DIAMETER. THIS WAS CONSERVATIVELY MANAGED BY ENDOSCOPIC NASOBILIARY DRAINAGE AND ANTIBIOTIC ADMINISTRATION. NO FURTHER INFORMATION ON THE LACERATION WAS PUBLISHED IN EITHER ARTICLE. ISHIHARA Y, MATSUMOTO K, KATO H, ET AL. TREATMENT OUTCOMES, INCLUDING RISK FACTORS OF STONE RECURRENCE, FOR HEPATOLITHIASIS USING BALLOON-ASSISTED ENDOSCOPY IN PATIENTS WITH HEPATICOJEJUNOSTOMY (WITH VIDEO). SURG ENDOSC. 2021;35(4):1895-1902. HTTPS://DOI.ORG/10.1007/S00464-020-08139-6. TIME FRAME: JANUARY 2008-DECEMBER 2018. MATSUMOTO K, TSUTSUMI K, ET AL. EFFECTIVENESS OF PERORAL DIRECT CHOLANGIOSCOPYUSING AN ULTRASLIM ENDOSCOPE FOR THE TREATMENT OF HEPATOLITHIASIS IN PATIENTS WITH HEPATICOJEJUNOSTOMY (WITH VIDEO). SURG ENDOSC. 2016; 30:1249-1254. HTTPS://DOI.ORG/10.1007/S00464-015-4323-6. TIME FRAME: APRIL 2012-MAY 2014.

    Description of Event or Problem · 0

    THIS CORRECTION FOLLOW UP REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL REPORT SUBMITTED RELATING TO THIS EVENT. REFERENCE THE ADDITIONAL MANUFACTURER NARRATIVE- NOTES SECTION H10 FOR THIS JUSTIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2690627 QUANTUM TTC BILIARY BALLOON DILATOR FGE STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE COOK ENDOSCOPY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention ENDOSCOPE, UNKNOWN MAKE OR MODEL