BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

    MDR report key: 4190397 · Received October 21, 2014

    Report

    Report Number
    2024168-2014-06865
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 26, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DRA
    PMA / PMN Number
    K112239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE INCIDENT INFORMATION WAS REVIEWED; HOWEVER, A FAILURE ANALYSIS OF THE STEERABLE GUIDING CATHETER (SGC) COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THEREFORE, THE ANALYSIS OF THIS COMPLAINT WILL BE AN ASSESSMENT OF THE MANUFACTURING RECORDS/COMPLAINT HISTORY AND INFORMATION PROVIDED TO ABBOTT VASCULAR. POTENTIAL CAUSES FOR THE REPORTED FAILURE TO ADVANCE THE SGC RESULTING IN THE BREAK OF THE SGC TIP CAN INCLUDE, BUT ARE NOT LIMITED TO, PROCEDURAL CONDITIONS / USER TECHNIQUE ASSOCIATED WITH DILATION OF THE PATIENT ANATOMY, PATIENT ANATOMICAL CONDITIONS (TORTUOUS VESSEL, ETC), OR MANUFACTURING ANOMALIES (INSUFFICIENT TIP BONDING). WITH RESPECT TO PATIENT ANATOMY AND/OR PROCEDURAL CONDITIONS / USER TECHNIQUE, THE FAILURE TO ADVANCE THE SGC RESULTING IN SOFT TIP BREAK MAY BE INFLUENCED BY INSUFFICIENT DILATION OF THE FEMORAL VEIN PRIOR TO INSERTION OR TORTUOUS PATIENT ANATOMY. BASED ON THE INFORMATION REVIEWED, IT IS LIKELY THAT THE INSERTION SITE WAS NOT FULLY DILATED PRIOR TO ATTEMPTS TO INSERT THE SGC; AS A RESULT, THE SGC COULD NOT ADVANCE INTO THE FEMORAL VEIN, AND THE SOFT TIP BECAME BROKEN WHILE ATTEMPTING TO INSERT THE SGC. THE FAILURE TO ADVANCE THE SGC RESULTING IN THE BREAKING OF THE SGC SOFT TIP WAS DETERMINED TO BE RELATED TO USER TECHNIQUE / OPERATION CONTEXT. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE COMPLAINT HANDLING DATABASE INDICATED THERE HAD BEEN NO SIMILAR TIP BREAK INCIDENTS REPORTED FOR THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ONE MITRACLIP IS FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    THIS IS BEING SUBMITTED TO REPORT THE STEERABLE GUIDE CATHETER TIP BREAK THAT OCCURRED DURING INSERTION. IT WAS REPORTED THAT THE INITIAL MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2014, TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 3-4. THREE MITRACLIPS WERE IMPLANTED AND THE MR WAS REDUCED TO 2. ON APPROXIMATELY (B)(6) 2014, THE PATIENT PRESENTED TO THE HOSPITAL WITH DYSPNEA AND WAS TREATED WITH DIURETICS. IT WAS FOUND THAT ONE PREVIOUSLY IMPLANTED CLIP HAD DETACHED FROM THE POSTERIOR LEAFLET, AND REMAINED SECURE ON THE ANTERIOR LEAFLET. ADDITIONALLY, THE POSTERIOR LEAFLET WAS TORN AND THE MR HAD INCREASED TO 3. ON (B)(4) 2014, AN ADDITIONAL MITRACLIP PROCEDURE WAS PERFORMED TO TREAT THE NEW MR GRADE OF 3 AND THE TORN LEAFLET. DURING INSERTION OF THE STEERABLE GUIDE CATHETER (SGC 1034702517), THE TIP BROKE DUE TO THE HARDENED GROIN ACCESS SITE. THE GROIN WAS DILATED, AND A NEW SGC WAS USED SUCCESSFULLY. ONE CLIP WAS IMPLANTED AND THE MR WAS REDUCED TO 2-3. THE PATIENT WAS CLINICALLY STABLE POST-PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667457 MITRACLIP SYSTEM STEERABLE GUIDE CATHETER STEERABLE GUIDE CATHETER DRA AV-TEMECULA-CT 10347025

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR 3 IMPLANTED MITRACLIPS