BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHASTIPP

    MDR report key: 19122625 · Received April 16, 2024

    Report

    Report Number
    1220948-2024-00096
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    March 19, 2024
    Report Date
    April 16, 2024
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    DWQ
    UDI-DI
    00840663110186
    PMA / PMN Number
    K212894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE NOT RECEIVED THE PRODUCT FOR INVESTIGATION. HOWEVER, IT WAS REPORTED THE CAUSE OF THE SHEATH BEING TOO SHORT WAS DUE TO THE NURSE TEARING IT, WHICH CAUSED IT NOT TO FULLY DEPLOY. IT WAS STATED THE NURSE PULLED THE TAB PERPENDICULARLY RATHER THAN PARALLEL TO THE TUBE. THE SURGICAL TEAM WAS PROVIDED ADDITIONAL INSTRUCTIONS FOR FUTURE CASES. THE CAUSE OF THE REPORTED ISSUE WAS DUE TO THE NURSE NOT PROPERLY FOLLOWING THE INSTRUCTION FOR USE. PER THE IFU: "POSITION THE DEVICE TO HOLD THE SHAFT UP AND THE HANDLE DOWN. WHILE CONTINUING TO HOLD THE SHAFT WITH ONE HAND, THE STERILE NURSE USES ANOTHER HAND TO GENTLY APPLY TENSION TO THE PULL TAB TO DEPLOY THE MICROBIAL BARRIER SHEATH OVER THE RESECTOR HANDPIECE. USE CARE NOT TO TOUCH THE NON-STERILE RESECTOR HANDPIECE. CONTINUE PULLING THE MICROBIAL BARRIER SHEATH UNTIL IT IS FULLY DEPLOYED AND THE TEAL HUB ON THE DISPOSABLE RESECTOR IS NO LONGER UNDER THE SHEATH. WITH THE MICROBIAL BARRIER SHEATH IN PLACE, THE ENTIRE DEVICE MAY NOW BE PLACED IN THE STERILE FIELD. USE CAUTION WHEN HANDLING THE DEVICE AND MICROBIAL BARRIER SHEATH. IF THERE IS ANY REASON TO SUSPECT THAT THE SHEATH IS DAMAGED OR COMPROMISED, IMMEDIATELY STOP AND REPLACE THE RESECTOR. THE LOT HISTORY RECORD FOR THE DEVICE WAS REVIEWED, NO ISSUES WERE FOUND DURING MANUFACTURING OR PACKAGING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. WE HAVE NOT RECEIVED ANY SIMILAR COMPLAINTS RELATED TO THIS LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LENGTH OF THE RESECTOR SHEATH WAS TOO SHORT. UPON FURTHER REVIEW, IT WAS FOUND THAT THE SHEATH WAS NOT FULLY DEPLOYED WHEN IN USE. INSPECTION OF THE SHEATH (POST OPERATION) FOUND THAT THE SHEATH WAS TORN DUE TO THE NURSE PULLING THE TAB PERPENDICULARLY RATHER THAN PARALLEL TO THE TUBE. THIS DID NOT ALLOW THE SHEATH TO FULLY DEPLOY. THE SURGICAL TEAM WAS PROVIDED ADDITIONAL INSTRUCTIONS FOR FUTURE CASES. NO INJURY WAS REPORTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231183 PHASTIPP DISPOSABLE RESECTOR DWQ LEMAITRE VASCULAR, INC. TIP1008 00840663110186

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown