BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

    MDR report key: 4153219 · Received October 8, 2014

    Report

    Report Number
    2024168-2014-06535
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DRA
    PMA / PMN Number
    K112239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE INCIDENT INFORMATION PROVIDED TO ABBOTT VASCULAR, THE MANUFACTURING RECORDS/COMPLAINT HISTORY AND THE ANALYSIS OF THE RETURNED STEERABLE GUIDING CATHETER (SGC) AND DILATOR WERE REVIEWED. ANALYSIS OF THE RETURNED SGC DEVICE AND DILATOR CONFIRMED THAT THE ROTATING HEMOSTASIS VALVE (RHV) CAP OF THE DILATOR WAS RETURNED SEPARATED FROM THE DILATOR. NO DAMAGE WAS OBSERVED ON THE THREADS OF THE DILATOR; HOWEVER THE WHITE O-RING THAT IS HOUSED WITHIN THE DILATOR WAS OBSERVED TO BE MISSING. POTENTIAL CAUSES FOR DETACHMENT OF THE CAP OF THE DILATOR ROTATING HEMOSTASIS VALVE (RHV) CAN INCLUDE, BUT ARE NOT LIMITED TO, USER TECHNIQUE/PROCEDURAL CONDITIONS (EXCESSIVE FORCE DURING DEVICE PREP) OR MANUFACTURING ANOMALIES (MOLD DEFICIENCIES OR DAMAGED THREADS). WITH RESPECT TO USER TECHNIQUE/PROCEDURAL CONDITIONS, THE CAP CAN BECOME DETACHED FROM THE RHV DURING HANDLING BY THE USER. RETURNED DEVICE TESTING CONFIRMED THAT THE RHV CAP WAS ABLE TO BE REATTACHED TO THE RHV, AND THE DILATOR FUNCTIONED AS EXPECTED. IT IS POSSIBLE THAT THE CAP WAS INADVERTENTLY PULLED OFF FROM THE RHV AFTER UNPACKING OF THE DEVICE; HOWEVER, THIS CANNOT BE CONFIRMED. BASED ON THE INFORMATION REVIEWED, A DEFINITIVE CAUSE FOR THE REPORTED DETACHMENT OF THE DILATOR RHV CAP CANNOT BE DETERMINED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A SIMILAR ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    THIS IS BEING SUBMITTED TO REPORT THAT THE O-RING WAS NOTED TO BE MISSING DURING DEVICE ANALYSIS, WHICH HAS THE POTENTIAL TO CAUSE A LEAK AND MAY CONTRIBUTE TO PATIENT INJURY. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. DURING PREPARATION OF THE STEERABLE GUIDING CATHETER (SGC) IT WAS FOUND THAT THE ROTATING HEMOSTATIC VALVE (RHV) WAS NOT SECURELY CONNECTED TO THE Y-PORT OF THE DILATOR. THE RHV WAS UNABLE TO BE SCREWED ONTO THE Y-PORT, AND WAS EASILY DISCONNECTED. THERE WAS NO LEAKS NOTED AS THE VALVE WAS NEVER CONNECTED TO THE DILATOR. THE SAME SGC WAS USED WITH A NEW DILATOR. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. TWO CLIPS WERE IMPLANTED AND THE MR WAS REDUCED TO 2. RETURNED DEVICE ANALYSIS FOUND THAT THE O-RING WAS MISSING FROM THE RHV OF THE DILATOR. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631245 MITRACLIP SYSTEM STEERABLE GUIDE CATHETER STEERABLE GUIDE CATHETER DRA AV-TEMECULA-CT 10295225

    Patients

    Seq Age Sex Outcome Treatment
    1