BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELSIOR SL-10 STRAIGHT 2 TIP 150CM

    MDR report key: 21125961 · Received January 10, 2025

    Report

    Report Number
    3008881809-2025-00031
    Event Type
    Malfunction
    Date Received
    January 10, 2025
    Date of Event
    September 14, 2024
    Report Date
    January 10, 2025
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    DQY
    UDI-DI
    04546540688217
    PMA / PMN Number
    K013789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO THE AUTOMATED MANUFACTURING EXECUTION SYSTEM (MES) THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING THE VISUAL INSPECTION, THERE WAS A SIGNIFICANT AMOUNT OF DRIED PROCEDURAL FLUID ON THE CATHETER SHAFT. THE MICROCATHETER WAS NOTED TO BE BLOCKED/OCCLUDED WITH DRIED PROCEDURAL FLUID/BLOOD. THE HUB AND TIP WERE NOTED TO BE INTACT. DURING THE FUNCTIONAL INSPECTION, A 0.023" PIN GAUGE WAS VERIFIED TO MEET THE CATHETER SHAFT WHEN INSERTED INTO THE CATHETER HUB. AN ATTEMPT WAS MADE TO FLUSH THE MICROCATHETER UNSUCCESSFULLY, A 0.0158" PATENCY MANDREL WAS ADVANCED THROUGH THE MICROCATHETER, SEVERE FRICTION WAS NOTED AS THE MANDREL ADVANCED THROUGH THE CATHETER SHAFT AND EVENTUALLY GOT STUCK AT 50CM FROM THE HUB, THE SHAFT WAS CUT TO REVEAL WHAT APPEARED TO BE POLYTETRAFLUOROETHYLENE (PTFE) INNER LINING AND PROCEDURAL FLUID. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTION FOR USE (DFU). AS WELL, THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT. THE REPORTED EVENT WAS CONFIRMED BASED ON ANALYSIS. THE DEVICE DID NOT MEET SPECIFICATIONS WHEN RECEIVED FOR COMPLAINT INVESTIGATION BASED ON THE ANALYZED ANOMALIES NOTED TO THE DEVICE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DEVICE WAS PREPARED FOR USE AS PER THE DIRECTIONS FOR USE, THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION DURING PREPARATION/PRIOR TO USE ON THE PATIENT AND CONTINUOUS FLUSH WAS MAINTAINED THROUGHOUT THE CLINICAL PROCEDURE. THE PATIENTS ANATOMY WAS MODERATELY TORTUOUS. IT WAS REPORTED DURING BASILAR ARTERY (BA) TIP ANEURYSM EMBOLIZATION CASE. PREPARED TO DO Y STYLE STENT ASSISTED COIL EMBOLIZATION. AFTER USING A MICROCATHETER TO DEPLOY ONE STENT, CONTINUED TO DELIVER THE SAME MICROCATHETER TO PASS THE MESH OF STENT TO REACH OPPOSITE POSTERIOR CEREBRAL ARTERY (PCA). HOWEVER AFTER SEVERAL TRIES THE MICROCATHETER COULD NOT BE DELIVERED TO OPPOSITE PCA SO THE OPERATOR FELT THE TIP OF MICROCATHETER COULD NOT WORK ANY MORE. REPLACED IT WITH ANOTHER MICROCATHETER IN SAME CATALOG TO CONTINUE THE PROCEDURE. THE DEVICE WAS RETURNED FOR ANALYSIS, AND IT WAS NOTED THAT A SIGNIFICANT AMOUNT OF DRIED PROCEDURAL FLUID ON THE CATHETER SHAFT. THE CATHETER TIP WAS INTACT. THE MICROCATHETER WAS NOTED TO BE BLOCKED/OCCLUDED WITH DRIED PROCEDURAL FLUID/BLOOD. A 0.023" PIN GAUGE WAS VERIFIED TO MEET THE CATHETER SHAFT WHEN INSERTED INTO THE CATHETER HUB. AN ATTEMPT WAS MADE TO FLUSH THE MICROCATHETER UNSUCCESSFULLY, A 0.0158" PATENCY MANDREL WAS ADVANCED THROUGH THE MICROCATHETER, SEVERE FRICTION WAS NOTED AS THE MANDREL ADVANCED THROUGH THE CATHETER SHAFT AND EVENTUALLY GOT STUCK AT 50CM FROM THE HUB, THE SHAFT WAS CUT TO REVEAL WHAT APPEARED TO BE PTFE INNER LINING AND PROCEDURAL FLUID/BLOOD. BASED ON A REVIEW OF ALL AVAILABLE INFORMATION THE PTFE INNER LINING WAS MOST LIKELY DAMAGED DURING ANALYSIS WHEN TRYING TO ADVANCE THE PATENCY MANDREL THROUGH A BLOCKED SHAFT. A STENT WAS DELIVERED SUCCESSFULLY USING THE SUBJECT MICROCATHETER DURING THE PROCEDURE WITH NO REPORTS OF FRICTION. THERE MAY HAVE BEEN DIFFICULTIES PASSING THE MESH OF STENT TO REACH OPPOSITE PCA DUE TO SOME PROCEDURAL FACTORS. THE PHYSICIAN WOULD HAVE PERCEIVED THE CATHETER TIP TO BE DAMAGED. THERE MAY HAVE BEEN AN ISSUE WITH FLUSH DURING THE PROCEDURE DUE TO THE AMOUNT OF DRIED PROCEDURAL FLUID/BLOOD IN THE CATHETER SHAFT. THE REPORTED 'DIFFICULTY ENGAGING TARGET VESSEL' AND 'CATHETER TIP DAMAGED' AS WELL AS THE ANALYSED 'DEVICE DIFFICULT TO FLUSH', 'CATHETER SHAFT BLOCKED/OCCLUDED', 'CATHETER SHAFT FRICTION' AND 'CATHETER PTFE INNER LINING PEELING' WILL BE ASSIGNED A PROBABLE ASSIGNABLE CAUSE OF PROCEDURAL FACTORS AS THIS COMPLAINT APPEARS TO BE ASSOCIATED WITH A PRODUCT THAT MET STRYKER DESIGN AND MANUFACTURING SPECIFICATIONS AND WAS USED IN ACCORDANCE WITH THE DFU, BUT PERFORMANCE WAS LIMITED DUE TO PROCEDURAL FACTORS DURING USE.

    Description of Event or Problem · 0

    THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT CATHETER POLYTETRAFLUOROETHYLENE (PTFE) INNER LINING WAS PEELING. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462210 EXCELSIOR SL-10 STRAIGHT 2 TIP 150CM CATHETER, PERCUTANEOUS DQY STRYKER NEUROVASCULAR CORK 24605724 04546540688217

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male NEUROFORM ATLAS STENT (STRYKER)