BEUDAMED
    FDA Adverse Event Death Summary report: N

    TURNPIKE LP

    MDR report key: 6195513 · Received December 21, 2016

    Report

    Report Number
    2134812-2016-00088
    Event Type
    Death
    Date Received
    December 21, 2016
    Date of Event
    November 30, 2016
    Report Date
    December 1, 2016
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Product Code
    DQY
    UDI-DI
    M20656390
    PMA / PMN Number
    K142065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS LIKELY THAT THE TORTUOUS ENVIRONMENT CONTRIBUTED TO THE DEVICE FAILURE. THE TURNPIKE IS DESIGNED TO BE USED IN EXTREME TORTUOSITY. THE EVIDENCE FOUND DURING THE RETURNED PRODUCT EVALUATION SHOW THAT THE CATHETER WAS TWISTED AND SHAFT WAS DAMAGED DUE TO TORQUING AGAINST RESISTANCE. THE EVENT DESCRIPTION ALONG WITH THE RETURNED PRODUCT EVALUATION PROVIDED SUFFICIENT EVIDENCE TO DETERMINE THAT THE MOST LIKELY ROOT CAUSE WAS MISUSE BY CLINICIAN. THE EVENT DESCRIPTION STATES, "APPLYING SIGNIFICANT TORQUE TO THE DEVICE". THE IFU SPECIFICALLY WARNS TO "NEVER ADVANCE, WITHDRAW OR ROTATE AN INTRAVASCULAR DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF RESISTANCE IS DETERMINED BY FLUOROSCOPY. MOVEMENT OF THE CATHETER OR GUIDEWIRE AGAINST RESISTANCE MAY RESULT IN SEPARATION OF THE CATHETER OR GUIDEWIRE TIP, OTHER DEVICE DAMAGE, OR VESSEL INJURY." IN ADDITION, THE IFU CAUTIONS, "WHEN THE CATHETER IS IN THE BODY, IT SHOULD BE MANIPULATED ONLY UNDER FLUOROSCOPY. DO NOT ATTEMPT TO MOVE THE CATHETER WITHOUT OBSERVING THE RESULTANT TIP RESPONSE, AS CATHETER DAMAGE OR VESSEL INJURY MAY OCCUR."

    Description of Event or Problem · 1

    CTO OF LEFT VENA, STUCK IN SEPTUM, TIP OF CATHETER BROKE: DURING THE TREATMENT OF AN RCA CTO USING A RETROGRADE APPROACH, PHYSICIAN HAD TO REMOVE A (FIRST) TURNPIKE LP CATHETER DUE TO THE LOSS OF GUIDEWIRE MOVEMENT AFTER APPLYING SIGNIFICANT TORQUE TO THE DEVICE. HE SUBSEQUENTLY WENT BACK IN WITH A SECOND TURNPIKE LP AND ALSO LOST WIRE MOVEMENT. HE REMOVED ONE GUIDEWIRE AND TRIED TO RE-ADVANCE A SECOND WIRE. HE WAS UNABLE TO ADVANCE THE SECOND WIRE. DURING A SUBSEQUENT ATTEMPT TO WITHDRAWAL OF THE TURNPIKE SIGNIFICANT RESISTANCE WAS ENCOUNTERED. AFTER APPLYING CLOCKWISE AND COUNTERCLOCKWISE ROTATIONS THE CATHETER SHAFT DETACHED LEAVING A PORTION OF THE TURNPIKE CATHETER IN THE SEPTAL AND A PORTION INTO THE LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN FELT THAT HE HAD OVER ROTATED THE CATHETER BEYOND THE DEVICE'S LIMITS. THE PATIENT WAS SENT TO SURGERY, THE CATHETER WAS REMOVED AND THE PATIENT RECEIVED CORONARY ARTERY BYPASS INSTEAD OF THE PLANNED CTO-PCI. THE PATIENT IS REPORTED TO BE DOING FINE. RECEIVED (B)(6) 2016: NEW INFORMATION REGARDING THIS CASE. WE HAVE BECOME AWARE THAT THE PT. SUDDENLY DETERIORATED AND BECAME HYPOTENSIVE. THE SURGEON HAD TO OPEN HER UP IN THE CCU, BUT SHE DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846330 TURNPIKE LP CATHETER DQY VASCULAR SOLUTIONS, INC. 5639 598415 M20656390

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R