BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURNPIKE LP 135CM

    MDR report key: 20105582 · Received August 30, 2024

    Report

    Report Number
    2134812-2024-00047
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    August 1, 2024
    Report Date
    August 19, 2024
    Manufacturer
    VASCULAR SOLUTIONS LLC
    Product Code
    DQY
    UDI-DI
    10841156108731
    PMA / PMN Number
    K151981
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN # (B)(4). COMPLETE UDI IS NOT AVAILABALE AS THE LOT# WAS NOT PROVIDED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    QN#(B)(4). ONE UNIT OF TURNPIKE WAS RETURNED FOR EVALUATION. BLOOD PARTICULATES WERE NOTED ON THE UNIT. THE UNIT WAS DECONTAMINATED AND INSPECTED. APPROXIMATELY 2 MM OF TIP SEPARATION WAS OBSERVED. THE REMAINING TIP MATERIAL WAS FATIGUED. LUMEN OF THE SHAFT WAS ALSO BULGED. SEPARATED TIP WAS NOT RETURNED. A DHR REVIEW WAS COMPLETED FOR LOT 73M2200338. NO ISSUES OR NON-CONFORMITIES WERE NOTED. THE DAMAGES ARE LIKELY TO HAVE OCCURRED DURING USE WHEN ADVANCED AGAINST A TIGHT LESION. THE IFU STATES THE FOLLOWING WARNING AND PRECAUTION: NEVER ADVANCE, WITHDRAW, OR ROTATE AN INTRAVASCULAR DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THE RESISTANCE IS DETERMINED BY F LUOROSCOPY. MOVEMENT OF THE CATHETER OR GUIDEWIRE AGAINST RESISTANCE MAY RESULT IN SEPARATION OF THE CATHETER OR GUIDEWIRE TIP, OTHER DEVICE DAMAGE, OR VESSEL INJURY. DO NOT ROTATE THE CATHETER MORE THAN TWO (2) CONSECUTIVE 360 ROTATIONS IN EITHER DIRECTION IF THE DISTAL TIP IS NOT ALSO ROTATING AND ADVANCING, AS IT MAY RESULT IN SEPARATION OF THE CATHETER, DAMAGE TO THE CATHETER, OR VESSEL INJURY EXERCISE CARE IN HANDLING THE CATHETER DURING A PROCEDURE TO REDUCE THE POSSIBILITY OF ACCIDENTAL BREAKAGE, BENDING, OR KINKING. NO INFORMATION WAS PROVIDED ON NUMBER OF ROTATIONS PERFORMED WITH THE TIP TRAPPED IN THE LESION. AS PER THE ADDITIONAL INFORMATION RECEIVED, THE TIP WAS REMOVED. ANOTHER TURNPIKE WAS USED TO COMPLETE THE CASE. BASED ON THE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE ISSUE IS OPERATIONAL CONTEXT AND/OR UNINTENDED USE ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "I AM REACHING OUT REGARDING A DAMAGED TELEFLEX PRODUCT (REF 5638). THIS PRODUCT WAS USED DURING A PATIENT PROCEDURE AND IT MALFUNCTIONED. " ADDITIONAL INFORMATION RECEIVED ON 19AUG2024: "I SPOKE WITH THE MANAGER SHE WAS IN THE CASE. SHE TOLD ME SHE DOES NOT HAVE THE "RESOURCES" TO RETRIEVE ALL THE DETAILS, BUT TOLD ME THAT IT WAS A VERY DIFFICULT CASE WITH A TIGHT LESION AND THE TURNPIKE SEEMED TO BE STUCK AND WHEN THEY TRIED TO MANEUVER THE CATHETER A PIECE OF THE TIP SEEMED TO DISLOCATE. THEY PLACED A WIRE NEXT TO THE MICROCATHETER AND WERE ABLE TO REMOVE EVERYTHING TOGETHER. NOTHING WAS LEFT BEHIND AND THEY WERE ABLE TO COMPLETE THE CASE USING ANOTHER TURNPIKE LP. THE PATIENT WAS REPORTED AS FINE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "I AM REACHING OUT REGARDING A DAMAGED TELEFLEX PRODUCT (REF (B)(4)). THIS PRODUCT WAS USED DURING A PATIENT PROCEDURE AND IT MALFUNCTIONED." ADDITIONAL INFORMATION RECEIVED ON 19AUG2024: "I SPOKE WITH THE MANAGER SHE WAS IN THE CASE. SHE TOLD ME SHE DOES NOT HAVE THE "RESOURCES" TO RETRIEVE ALL THE DETAILS BUT TOLD ME THAT IT WAS A VERY DIFFICULT CASE WITH A TIGHT LESION AND THE TURNPIKE SEEMED TO BE STUCK AND WHEN THEY TRIED TO MANEUVER THE CATHETER A PIECE OF THE TIP SEEMED TO DISLOCATE. THEY PLACED A WIRE NEXT TO THE MICROCATHETER AND WERE ABLE TO REMOVE EVERYTHING TOGETHER. NOTHING WAS LEFT BEHIND AND THEY WERE ABLE TO COMPLETE THE CASE USING ANOTHER TURNPIKE LP. THE PATIENT WAS REPORTED AS FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911176 TURNPIKE LP 135CM CATHETER, PERCUTANEOUS DQY VASCULAR SOLUTIONS LLC 10841156108731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED| NOT REPORTED