BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

    MDR report key: 4141131 · Received October 3, 2014

    Report

    Report Number
    2024168-2014-06435
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DRA
    PMA / PMN Number
    K112239
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE CDS IS FILED UNDER A SEPARATE MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. THE ANALYSIS OF THIS COMPLAINT WAS AN ASSESSMENT OF THE MANUFACTURING RECORDS/COMPLAINT HISTORY AND INFORMATION PROVIDED TO ABBOTT VASCULAR. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO NON-CONFORMANCES ASSOCIATED WITH THE REPORTED LOT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE INDICATED THERE HAD BEEN NO SIMILAR INCIDENTS OF LEAK REPORTED FOR THIS LOT. POTENTIAL CAUSES FOR A LEAK IN THE SGC HEMOSTASIS VALVE CAN INCLUDE, BUT ARE NOT LIMITED TO, USER TECHNIQUE/PROCEDURAL CONDITIONS, SUCH AS THE STEPS UTILIZED TO DE-AIR THE DEVICE DURING GUIDE PREPARATION, USER TECHNIQUE DURING CDS INSERTION, LOOSE CONNECTIONS BETWEEN THE LUER AND ACCESSORY DEVICES (I.E. STOPCOCK, HIGH PRESSURE TUBING OR SYRINGE) OR MANUFACTURING ANOMALIES (TEARS OR MISSING SILICONE IN THE VALVE). BASED ON THE INFORMATION REVIEWED, THE REPORTED LEAK IN THE HEMOSTASIS VALVE OF THE SGC WAS DUE TO USER TECHNIQUE/PROCEDURAL CONTEXT, AS THE PHYSICIAN PUSHED ON THE STEERABLE SLEEVE DURING CDS INSERTION, CAUSING THE DEVICE INSERTION TO BE CROOKED AND ULTIMATELY ALLOWING AIR INTO THE VALVE. THERE DOES NOT APPEAR TO BE ANY EVIDENCE OF A PRODUCT DEFICIENCY ASSOCIATED WITH THIS DEVICE.

    Description of Event or Problem · 1

    THIS REPORT IS FILED FOR AIR IN THE HEMOSTATIC VALVE, REQUIRING ASPIRATION TO PREVENT AIR BUBBLES IN THE ANATOMY. IT WAS REPORTED THAT THE MITRACLIP STEERABLE GUIDE CATHETER (SGC) WAS IN THE ANATOMY WHEN THE CLIP DELIVERY SYSTEM (CDS) WAS BEING INSERTED THROUGH THE SGC WITHOUT RESISTANCE. THE CLIP INTRODUCER (CI) WAS HALF WAY INSIDE THE HEMOSTATIC VALVE WHEN THE PHYSICIAN PUSHED ON THE STEERABLE SLEEVE AND THE CI WENT IN CROOKED, WHICH ALLOWED AIR TO ENTER THE HEMOSTATIC VALVE. THE CDS WAS PULLED BACK, BUT THE CLIP CAUGHT ON THE CI AND FRAYED THE TIP OF THE CI. AFTER THE CDS WAS REMOVED FROM THE SGC, THE AIR WAS ASPIRATED OUT OF THE HEMOSTATIC VALVE. ANOTHER CDS WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. ONE MITRACLIP WAS IMPLANTED IN THE PATIENT WITH DEGENERATIVE MITRAL REGURGITATION (MR) REDUCING THE MR FROM 4+ TO 1 TO 2. THERE WAS NO CHALLENGING PATIENT ANATOMY NOTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619126 MITRACLIP SYSTEM STEERABLE GUIDE CATHETER STEERABLE GUIDE CATHETER DRA AV-TEMECULA-CT 40623U1

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention MITRACLIP CLIP DELIVERY SYSTEM