BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCELSIOR SL-10 PRE-SHAPED 45 150CM

    MDR report key: 4458107 · Received January 27, 2015

    Report

    Report Number
    3008853977-2015-00034
    Event Type
    Injury
    Date Received
    January 27, 2015
    Date of Event
    January 16, 2015
    Report Date
    January 16, 2015
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    DQY
    PMA / PMN Number
    K042568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE WAS RETURNED WITH A GUIDEWIRE. VISUAL AND MICROSCOPIC INSPECTION OF THE RETURNED DEVICE DID NOT REVEAL ANY ANOMALIES. HOWEVER, THERE WAS BLOOD NOTED WITHIN THE CATHETER. THE DEVICE WAS FLUSHED WITHOUT DIFFICULTY AND BLOOD EXITED THE DISTAL END OF THE CATHETER. THE RETURNED 0.014¿ GUIDEWIRE WAS ADVANCED THROUGH THE MICROCATHETER WITHOUT DIFFICULTY. A 0.0158¿ PATENCY MANDREL AND A 0.016" PIN GAUGE WERE PASSED THROUGH THE MICROCATHETER WITHOUT DIFFICULTY. BLOOD INSIDE THE MICROCATHETER IS AN INDICATION THAT INSUFFICIENT FLUSH WAS USED. IT IS PROBABLE THAT THE CATHETER WAS NOT SUFFICIENTLY FLUSHED CAUSING BLOOD TO ENTER, BLOCKING AND OCCLUDING THE MICROCATHETER, THIS WOULD HAVE CAUSED RESISTANCE ADVANCING THE GUIDEWIRE. IT IS PROBABLE THAT THE FOREIGN MATTER REPORTED WAS A THROMBUS AS A RESULT OF BLOOD ENTERING THE CATHETER. THE DIRECTIONS FOR USE (DFU) WARN: ¿IN ORDER TO ACHIEVE OPTIMAL PERFORMANCE OF STRYKER NEUROVASCULAR MICROCATHETERS AND TO MAINTAIN THE LUBRICITY OF THE HYDROLENE® COATING SURFACE, IT IS CRITICAL THAT A CONTINUOUS FLOW OF APPROPRIATE FLUSH SOLUTION BE MAINTAINED BETWEEN THE STRYKER NEUROVASCULAR MICROCATHETER AND GUIDE CATHETER, AND THE MICROCATHETER AND ANY INTRALUMINAL DEVICE. IN ADDITION, FLUSHING AIDS IN PREVENTING CONTRAST CRYSTAL FORMATION AND/OR CLOTTING ON BOTH THE INTRALUMINAL DEVICE AND INSIDE THE GUIDE CATHETER AND/OR THE MICROCATHETER LUMEN." THEREFORE, A ROOT CAUSE OF DFU INSTRUCTION NOT FOLLOWED HAS BEEN ASSIGNED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ADVANCEMENT TO THE TARGET LESION, THE GUIDEWIRE WAS JAMMED INSIDE THE SUBJECT MICROCATHETER DUE TO RESISTANCE ENCOUNTERED. THEREFORE, BOTH DEVICES WERE REMOVED FROM THE PATIENT. AFTER THE MICROCATHETER WAS FLUSHED, UNKNOWN ¿FOREIGN MATTER¿ WAS FOUND INSIDE THE MICROCATHETER. THE PHYSICIAN ALLEGED THAT THIS MIGHT BE A THROMBUS FORMATION. THE MICROCATHETER AND GUIDEWIRE WERE CHANGED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ADVANCEMENT TO THE TARGET LESION, THE GUIDEWIRE WAS JAMMED INSIDE THE SUBJECT MICROCATHETER DUE TO RESISTANCE ENCOUNTERED. THEREFORE, BOTH DEVICES WERE REMOVED FROM THE PATIENT. AFTER THE MICROCATHETER WAS FLUSHED, UNKNOWN ¿FOREIGN MATTER¿ WAS FOUND INSIDE THE MICROCATHETER. THE PHYSICIAN ALLEGED THAT THIS MIGHT BE A THROMBUS FORMATION. THE MICROCATHETER AND GUIDEWIRE WERE CHANGED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61521 EXCELSIOR SL-10 PRE-SHAPED 45 150CM CATHETER, PERCUTANEOUS DQY STRYKER NEUROVASCULAR CORK 17742828

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GUIDEWIRE 0.014 (MANUFACTURER UNKNOWN)