BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACROSS ACCESS SOLUTION

    MDR report key: 16726407 · Received April 12, 2023

    Report

    Report Number
    2124215-2023-11330
    Event Type
    Malfunction
    Date Received
    April 12, 2023
    Date of Event
    February 1, 2023
    Report Date
    May 30, 2023
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DYB
    UDI-DI
    00685447011729
    PMA / PMN Number
    K183655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED VERSACROSS ACCESS SOLUTION WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. HE REPORTED ALLEGATION IS NOT CONFIRMED. TESTING AND ANALYSIS OF THE RETURNED SHEATH AND DILATOR DID NOT PROVIDE SUBSTANTIAL EVIDENCE OF CAUSING DIFFICULTY ADVANCING THE DEVICE THROUGH THE SEPTUM. THE INVESTIGATION CONCLUSION CODE, CAUSE NOT ESTABLISHED WAS SELECTED BASED ON THE INFORMATION PROVIDED WITHIN THE EVENT DESCRIPTION AND THE RESULTS OBTAINED DURING INVESTIGATION OF THE RETURNED PRODUCT. CAUSE NOT ESTABLISHED IS SUPPORTED BY THE FOLLOWING OBJECTIVE EVIDENCE: IN HOUSE INSPECTION DURING MANUFACTURING CONFIRMS THAT ALL SHEATH TIPS HAVE CONCENTRIC TIP, AND NO TIP ROLLBACK OBSERVED FROM TEST RESULTS OF PART II: TIP TRANSITION DEFORMATION CHECK FROM DHF TSS 6.10.6. AT THIS POINT, IT CAN BE CONCLUDED THAT UNKNOWN FACTORS MOST PROBABLY CONTRIBUTED TO THE EVENT. FIELD B3, DATE OF EVENT HAS BEEN POPULATED WITH THE FIRST DAY OF FEBRUARY AS AN APPROXIMATE, SINCE ONLY THE BSC AWARE DATE HAS BEEN PROVIDED, NO EVENT DATE IS AVAILABLE.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT HAS BEEN POPULATED WITH THE FIRST DAY OF FEBRUARY AS AN APPROXIMATE, SINCE ONLY THE BSC AWARE DATE HAS BEEN PROVIDED, NO EVENT DATE IS AVAILABLE. FIELD D2B. PRO CODE (PRODUCT CODE): DXF, DYB. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, A VERSACROSS SHEATH WAS SELECTED FOR USE. DURING THE PROCEDURE IT WAS DIFFICULT TO CROSS THE SEPTUM. NO FURTHER DETAILS WERE REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED. THE LOT NUMBER PROVIDED COULD NOT BE POPULATED IN THE SYSTEM. IT WAS FURTHER REPORTED THAT THE PHYSICIAN BELIEVES IT WAS TORTUOUS ANATOMY WITH CALCIUM BUILD UP ON THE SEPTUM. HE BELIEVES THE TRANSITION FROM THE DILATOR TO THE SHEATH GAVE THEM ISSUE. THEY ENDED UP TRYING A NEW SHEATH AND CROSSED JUST FINE. HE SAID THIS IS A PRETTY COMMON EVENT WHEN THERE IS A LOT OF CALCIUM BUILD UP ON THE SEPTUM

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, A VERSACROSS SHEATH WAS SELECTED FOR USE. DURING THE PROCEDURE IT WAS DIFFICULT TO CROSS THE SEPTUM. NO FURTHER DETAILS WERE REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED. THE LOT NUMBER PROVIDED COULD NOT BE POPULATED IN THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211382 VERSACROSS ACCESS SOLUTION INTRODUCER, CATHETER DYB BAYLIS MEDICAL COMPANY INC. VXSK0021 VXFA141122 00685447011729
    562683 VERSACROSS ACCESS SOLUTION INTRODUCER, CATHETER DYB BAYLIS MEDICAL COMPANY INC. VXSK0021 VXFA141122 00685447011729

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown