BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURNPIKE LP 135CM

    MDR report key: 20332626 · Received September 30, 2024

    Report

    Report Number
    2134812-2024-00051
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    August 29, 2024
    Report Date
    September 5, 2024
    Manufacturer
    VASCULAR SOLUTIONS LLC
    Product Code
    DQY
    UDI-DI
    108411561100687
    PMA / PMN Number
    K151981
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). ONE-UNIT OF TURNPIKE (M:5638, LOT:73A2400147) WAS RETURNED TO OUR SITE FOR EVALUATION. BLOOD PARTICULATES WERE NOTED. UNIT WAS DECONTAMINATED AND INSPECTED. APPROXIMATELY 0.1 CM OF TIP MATERIAL WAS MISSING. THE REMAINING TIP MATERIAL PRESENT WAS FATIGUED. A DHR REVIEW WAS COMPLETED LOT:73A2400147 AND NO ISSUES OR NONCONFORMITIES WERE NOTED. CASE DETAILS WERE REVIEWED. DAMAGES OBSERVED ON THE TIP IS INDICATIVE OF THE MATERIAL SUBJECTED TO RESISTANCE. THIS IS LIKELY TO HAVE OCCURRED WHEN THE TIP WAS CONTINUED TO BE ROTATED WHEN LODGED WITHIN THE 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. AS PER THE ADDITIONAL INFORMATION RECEIVED, TIP WAS UNABLE TO BE RETRIEVED. TIP MIGRATED TO SMALL BRANCH (OM 3). PER THE PHYSICIAN, THIS IS OF SMALL CLINICAL SIGNIFICANCE. NO RESPONSE WAS RECEIVED ON WHETHER THE TIP WAS TRAPPED IN A LESION, NOR THE NUMBER OF ROTATIONS PERFORMED. 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: "A SMALL PORTION OF THE TIP OF THE TURNPIKE LP UTILIZED TO CROSS THE LCX OCCLUSION AND WIRE EXCHANGE FOR THE PCI DID BREAK OFF WITHIN A SMALL OM 3. ATTEMPTS WERE MADE TO RECAPTURE THIS BUT WERE UNSUCCESSFUL. THIS IS A SMALL VESSEL OF MINIMAL CLINICAL SIGNIFICANCE. AS A RESULT, NO FURTHER ATTEMPTS FOR RETRIEVAL WERE ATTEMPTED. IT WAS LEFT THERE. THE PATIENT IS REPORTED AS FINE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "A SMALL PORTION OF THE TIP OF THE TURNPIKE LP UTILIZED TO CROSS THE LCX OCCLUSION AND WIRE EXCHANGE FOR THE PCI DID BREAK OFF WITHIN A SMALL OM 3. ATTEMPTS WERE MADE TO RECAPTURE THIS BUT WERE UNSUCCESSFUL. THIS IS A SMALL VESSEL OF MINIMAL CLINICAL SIGNIFICANCE. AS A RESULT, NO FURTHER ATTEMPTS FOR RETRIEVAL WERE ATTEMPTED. IT WAS LEFT THERE. THE PATIENT IS REPORTED AS FINE.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2602649 TURNPIKE LP 135CM CATHETER, PERCUTANEOUS DQY VASCULAR SOLUTIONS LLC 73A2400147 108411561100687

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED.