BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIREX 12F STEERABLE SHEATH

    MDR report key: 7396735 · Received April 4, 2018

    Report

    Report Number
    1035166-2018-00025
    Event Type
    Malfunction
    Date Received
    April 4, 2018
    Date of Event
    March 1, 2018
    Report Date
    April 5, 2018
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    PMA / PMN Number
    K122960
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED BY THE USER AND AS SUCH, NO DEVICE ANALYSIS WAS PERFORMED. NO MANUFACTURING REJECTS OR ANOMALIES OF THIS EVENT TYPE WERE RECORDED IN THE DEVICE HISTORY RECORD. THE SHEATH PASSED ALL IN-PROCESS AND QA FINAL INSPECTION STEPS BEFORE SHIPPING TO THE CUSTOMER INCLUDING VISUAL, DIMENSIONAL AND LEAK TESTING. COMPLAINT REVIEW OF REPORTED LOT # C8-11789 FOUND NO ADDITIONAL REPORTS. PER DESTINO STEERABLE GUIDING SHEATH IN-PROCESS AND FINAL INSPECTION PROCEDURE: 100 PERCENT OF THE SAMPLE SIZE IS INSPECTED FOR DILATOR INSERTION: INSERT THE GO-NO-GO INTO PROXIMAL END OF THE SHAFT TO ASSURE INNER LUMEN IS FREE ANY OBSTRUCTS MATERIAL. THE DILATOR SHOULD PASS SMOOTHLY WITHOUT RESISTANCE THRU THE PROXIMAL END OF THE SHAFT ALL THE WAY THRU UNTIL IT IS PROTRUDING AT DISTAL TIP. THERE SHOULD BE MINIMAL GAP BETWEEN SHAFT AND DILATOR AT DISTAL END. THE DEVICE WAS IN USE FOR TREATMENT. AS PER THE REPORTED EVENT DESCRIPTION, THE DIFFICULTY IN ADVANCING THE DILATOR WAS NOTED DURING PREPARATION ACTIVITIES, HOWEVER THE DEVICE WAS USED IN THE PROCEDURE CONTRARY TO GUIDANCE GIVEN IN THE INSTRUCTIONS FOR USE. PER INSTRUCTIONS FOR USE (IFU): IT STATES " NEVER ADVANCE, TORQUE, OR WITHDRAW SHEATH WHEN RESISTANCE IS MET. DETERMINE CAUSE BY FLUOROSCOPY AND THEN TAKE REMEDIAL ACTION". THE DIREX STEERABLE SHEATH WILL NOT BE RETURNED FOR ANALYSIS, AS A RESULT, THE REPORTED ISSUE CANNOT BE CONFIRMED AND A ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED. A CAPA WAS OPENED TO INVESTIGATE AND DETERMINE APPROPRIATE CORRECTIVE/PREVENTATIVE ACTIONS TO PREVENT REOCCURRENCE OF SIMILAR EVENTS REPORTING DIFFICULTY INSERTING THE DILATOR. ANALYSIS SHOWS THE RISK FOR THIS FAILURE MODE REMAINS ACCEPTABLE. OSCOR WILL CONTINUE TO MONITOR THIS DEVICE FOR COMPLAINT TRENDS AND RISK. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    A PRELIMINARY REVIEW SHOWED THERE WERE NO MANUFACTURING REJECTS OR ANOMALIES OF THIS EVENT TYPE RECORDED IN THE DEVICE HISTORY RECORD. CONCLUSION NOT YET AVAILABLE AS THE INVESTIGATION IS ON-GOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR WAS TRIALING OUR 12FR DIREX SHEATHS FOR THE FIRST TIME FOR 2 SEPARATE AFIB ABLATION CASES BACK TO BACK USING THE MEDTRONIC CRYOBALLOON. BOTH DIREX WERE MODEL M004DS500 WITH LOT NUMBER C8-11789. THE FIRST CASE WENT WELL WITH NO ISSUES AND THE DILATOR AND SHEATH PERFORMED AS EXPECTED WITH A GOOD OUTCOME. IT WAS REPORTED IN THE SECOND AFIB CASE, THE SCRUB TECHNICIAN NOTICED THAT IT WAS DIFFICULT TO GET THE DILATOR SEATED ALL THE WAY INTO THE SHEATH HUB. PHYSICIAN USED THE DIREX FOR HIS TRANSSEPTAL PUNCTURE ACROSS THE FOSSA, BUT WHEN HE TRIED TO PULL THE DILATOR BACK OUT OF THE SHEATH, IT WOULD NOT COME OUT. HE THEN PINNED THE HANDLE OF THE DIREX DOWN TO THE PATIENT'S GROIN/LEG AREA AND HELD IT IN PLACE VERY TIGHTLY WHILE HE HAD THE SCRUB TECHNICIAN PULL ON THE DILATOR TO GET IT OUT OF THE SHEATH. THE DOCTOR DID NOT WANT TO PUT ANY COUNTER FORCE ON THE SHEATH AND ACCIDENTALLY PULL IT FURTHER INTO THE HEART. ONCE THE DILATOR WAS OUT, AND NO COMPLICATIONS OCCURRED, DOCTOR PROCEEDED WITH THE CASE. THE SHEATH REACHED ALL PULMONARY VEINS WELL, EXCEPT FOR THE RIGHT INFERIOR PULMONARY VEIN. THE PHYSICIAN REPORTED THAT THE SHEATH COULD NOT STEER TIGHT ENOUGH TO GET THE CRYOBALLOON INTO POSITION IN THE VEIN PROPERLY AND THE SHEATH DIDN'T HAVE ENOUGH BODY TO PUSH IT FORWARD AND SEAT PROPERLY. THE DOCTOR THEN TOOK OUT THE MDT CRYOBALLOON AND USED AN RF ABLATION CATHETER TO BURN AROUND THE RIPV IN ORDER TO GET ISOLATION OF ALL 4 VEINS. THE SHEATH AND DILATOR INNER LUMEN WERE FILLED WITH BLOOD AND AS SUCH, THE SHEATH AND DILATOR WERE THROWN AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239048 DIREX 12F STEERABLE SHEATH INTRODUCER, CATHETER DYB OSCOR INC. M004DS500 C8-11789

    Patients

    Seq Age Sex Outcome Treatment
    1