BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALET MICROCATHETER

    MDR report key: 4179882 · Received October 14, 2014

    Report

    Report Number
    2939520-2014-00084
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DQY
    PMA / PMN Number
    K112035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS FAILURE MODE WITHIN THIS LOT. THE DEVICE EVALUATION IS SUMMARIZED BELOW: A 3.5" SEGMENT OF THE DISTAL TIP OF THE CATHETER WAS SEPARATED FROM THE MICROCATHETER SHAFT. THE SEGMENT BETWEEN THIS 3.5" SEGMENT AND THE PROXIMAL PORTION WAS DISCARDED INCLUDING THE PORTION JUST PROXIMAL TO THE BREAK AS WELL AS THE TRANSITION REGION OF THE CATHETER. THE TIP WAS CRIMPED SLIGHTLY WITH NO LOSS OF PLASTIC. THE GOLD WIRE WAS COMPLETELY INTACT WITH ALL COILS ACCOUNTED FOR. THE BREAK HAD EXPOSED WINDINGS THAT HAD BEEN CUT OFF BY THE SURGEON. THE LINER WAS RUPTURED, AND THE PLASTIC INTACT AROUND THE BREAK. NO DELAMINATION OF THE MATERIAL AROUND THE BREAK WAS OBSERVED IN THE PIECE THAT WAS RETAINED. THE AREA OF THE BREAK WAS LOCATED APPROXIMATELY 1 CM FROM THE TRANSITION REGION. (B)(4). THE FAILURE MODE WAS SIMULATED BY KINKING A DEMONSTRATION VALET, AND THEN PULLING THE TIP USING THE KINK AS A FULCRUM. THE CATHETER RUPTURED DISTAL OF THE KINK AND STARTED UNCOILING IN A MANNER THAT WAS CONSISTENT WITH WHAT WAS OBSERVED BY THE PHYSICIAN. A KINK COULD HAVE BEEN GENERATED DURING MANUFACTURING, UNPACKING, OR THE PROCEDURE ITSELF AS THE CATHETER BECAME EMBEDDED IN CALCIUM AFTER REMOVAL OF THE SUPPORT WIRE IN TORTUOUS ANATOMY. DISCUSSIONS WITH THE PHYSICIAN INDICATED THAT THERE WERE NO OBSTRUCTIONS FOR THE TIP TO BECOME STUCK, AND HE AGREED THAT THE FAILURE MODES ASSOCIATED WITH THE KINKING DEMONSTRATION SEEMED THE MOST LIKELY. WE WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS FAILURE MODE VIA OUR STANDARD COMPLAINT REVIEW PROCESS AND DATA TRENDING ACTIVITIES.

    Description of Event or Problem · 1

    PHYSICIAN ENCOUNTERED RESISTANCE WHILE ATTEMPTING TO REMOVE 3.5 FR VALET MICROCATHETER. UNDER FLUOROSCOPY OBSERVED THE DEVICE FRACTURE AND THE INNER COIL UNWINDING. THE PHYSICIAN ELECTED TO HOLD PRESSURE ON THE RIGHT FEMORAL ARTERY TO MAINTAIN HEMOSTASIS AND CONSULTED A VASCULAR SURGEON. THE DECISION WAS MADE THAT IT WAS APPROPRIATE TO PERFORM A BILATERAL CUT DOWN. THE CUT DOWN WAS FIRST PERFORMED ON THE RIGHT SIDE AND THE WIRE FROM THE CATHETER WAS OBSERVED. THE PHYSICIANS THEN UTILIZED A CLAMP TO GRAB THE WIRE PROTRUDING FROM THE ARTERY AND PULLED THE WIRE OUT LEAVING A PORTION OF THE CATHETER IN THE LEFT ILIAC ARTERY. THE PHYSICIAN THEN ACCESSED THE LEFT FEMORAL ARTERY AND UTILIZED AN ENSNARE TO REMOVE THE REMAINING PIECE FROM THE PATIENT. FLUOROSCOPY WAS USED TO ENSURE THE ENTIRE REMAINING CATHETER WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ENDARTERECTOMY AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650530 VALET MICROCATHETER CATHETER, PERCUTANEOUS DQY VOLCANO CORPORATION 22-35-150-0 17001006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 6 FR 12CM SHEATH| ENSNARE| SOS CATHETER| TERUMO .035 ADVANTAGE WIRE| ABBOTT .035 SPARTACORE WIRE