BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURNPIKE SPRIAL

    MDR report key: 9590958 · Received January 15, 2020

    Report

    Report Number
    2134812-2020-00002
    Event Type
    Injury
    Date Received
    January 15, 2020
    Date of Event
    June 17, 2017
    Report Date
    December 18, 2019
    Manufacturer
    VASCULAR SOLUTIONS, LLC
    Product Code
    DQY
    PMA / PMN Number
    K151981
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS RETURNED FOR INVESTIGATION. THE DEVICE LOT HISTORY RECORD REVIEW INDICATED NO NON-CONFORMITIES RELATED TO THIS LOT, THEREFORE, SUPPORTING THE DEVICE MET MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS PRIOR TO SHIPMENT. THE EVENT DESCRIPTION STATES TIP OF THE TRAPLINER BROKE OFF FROM THE CATHETER. DELAMINATION OF THE SHAFT FROM THE PUSHROD WAS CONFIRMED. NO TIP DAMAGE WAS OBSERVED. THE DAMAGES ARE LIKELY TO HAVE OCCURRED DURING USE. ADDITIONAL INFORMATION WAS REQUESTED. NO RESPONSE WAS RECEIVED. A NONCONFORMANCE REQUEST WAS INITIATED TO INVESTIGATE THE COMPLAINT ISSUE. A SUPPLIER MANUFACTURING/PROCESS ISSUE WAS NOTED WITH THE TRAPLINER BACKBONE IN ADDITION TO OPERATIONAL USE OF THE CATHETER IN THE PROCEDURE. A SUPPLIER CORRECTIVE ACTION HAS BEEN ISSUED TO CAPTURE CHANGES. TELEFLEX WILL CONTINUE TO MONITOR AND TREND REPORTS FOR ANY SIMILAR EVENTS.

    Additional Manufacturer Narrative · 1

    A RETURNED PRODUCT EVALUATION WAS NOT COMPLETED. NO LOT NUMBER WAS PROVIDED. BASED ON THE LACK OF INFORMATION RECEIVED THE ROOT CAUSE FOR THE SEPARATION IS UNDETERMINABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED PER MEDWATCH 5091202 RECEIVED 12/18/2019: THE TURNPIKE SPIRAL CATHETER TIP BROKE OFF INSIDE CORONARY ARTERY WHILE ATTEMPTING PCI AND IT WAS UNABLE TO BE RETRIEVED AFTER MULTIPLE ATTEMPTS. IT WAS NOTED THAT CARDIAC SURGERY WAS CONSULTED, ANESTHESIOLOGY WAS PRESENT, AND THE PATIENT WAS MOVED TO THE OPERATING ROOM FOR AN EMERGENT BYPASS PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 11/27/2019 TO CONFIRM THE MANUFACTURER FOR THE DEVICE. NO FURTHER COMPLICATIONS WERE INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54203 TURNPIKE SPRIAL CATHETER DQY VASCULAR SOLUTIONS, LLC 5640 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention