BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACROSS CONNECT FOR FARADRIVE

    MDR report key: 22831767 · Received August 18, 2025

    Report

    Report Number
    2124215-2025-57520
    Event Type
    Injury
    Date Received
    August 18, 2025
    Date of Event
    July 29, 2025
    Report Date
    October 17, 2025
    Manufacturer
    BAYLIS MEDICALE CIE INC
    Product Code
    DXF
    PMA / PMN Number
    K150709
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE DID NOT RETURN FOR ANALYSIS. HOWEVER, THE REPORTED ALLEGATION RELATED TO THE HEMATOMA IS CONFIRMED THROUGH MEDIA, AND REMAINING REPORTED ALLEGATIONS ARE NOT CONFIRMED BASED ON THE MEDIA PROVIDED. IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. THIS PRODUCT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT HAS BEEN ASSESSED AS REPORTABLE AS THERE IS A SIMILAR PRODUCT APPROVED IN THE UNITED STATES. WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION RELATED TO UNITED STATES REGISTRATION AS THE SPECIFIC PRODUCT IS ONLY COMMERCIALLY AVAILABLE OUTSIDE OF THE UNITED STATES. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. CORRECTION TO THE INITIAL MDR IN BLOCK(S) PATIENT IDENTIFIER (A1), IN SECTION A - PATIENT INFORMATION.

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. THIS PRODUCT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT HAS BEEN ASSESSED AS REPORTABLE AS THERE IS A SIMILAR PRODUCT APPROVED IN THE UNITED STATES. WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION RELATED TO UNITED STATES REGISTRATION AS THE SPECIFIC PRODUCT IS ONLY COMMERCIALLY AVAILABLE OUTSIDE OF THE UNITED STATES. GOOD FAITH EFFORT ATTEMPTS TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT ARE IN PROGRESS, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED YET. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA/INFLAMMATION/SWELLING AND HEMATOMA. THE PROCEDURE WAS CANCELLED. DURING A FARAVIEW PROCEDURE, A VERSACROSS CONNECT FOR FARADRIVE WAS SELECTED FOR USE. THE TRANSSEPTAL WAS BEING PERFORMED HOWEVER DUE TO A CONNECTION ERROR ON THE PHYSICIAN'S SIDE THE FIRST SHOT LEAD TO AN ERROR. THE PHYSICIAN THEN MADE TWO INCONCLUSIVE APPLICATIONS AND A THIRD ONE WHICH SEEMED TO PASS THE ETO IMAGE. A FOURTH APPLICATION WAS MADE SUSPECTING THE CONTACT ON THE PATIO AT THE LEVEL OF THE AORTA. IT WAS SUSPECTED THAT THE VERSACROSS APPLICATION WAS ON THE WALL FROM THE OG OPPOSITE THE AORTA. THUS, THE PROCEDURE WAS STOPPED FOLLOWING THE TRANSSEPTAL CHECK-UP. NO MEDICATION WAS PRESCRIBED, BUT A SCANNER. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA/INFLAMMATION/SWELLING AND HEMATOMA. THE PROCEDURE WAS CANCELLED. DURING A FARAVIEW PROCEDURE, A VERSACROSS CONNECT FOR FARADRIVE WAS SELECTED FOR USE. THE TRANSSEPTAL WAS BEING PERFORMED HOWEVER DUE TO A CONNECTION ERROR ON THE PHYSICIAN'S SIDE THE FIRST SHOT LEAD TO AN ERROR. THE PHYSICIAN THEN MADE TWO INCONCLUSIVE APPLICATIONS AND A THIRD ONE WHICH SEEMED TO PASS THE ETO IMAGE. A FOURTH APPLICATION WAS MADE SUSPECTING THE CONTACT ON THE PATIO AT THE LEVEL OF THE AORTA. IT WAS SUSPECTED THAT THE VERSACROSS APPLICATION WAS ON THE WALL FROM THE OG OPPOSITE THE AORTA. THUS, THE PROCEDURE WAS STOPPED FOLLOWING THE TRANSSEPTAL CHECK-UP. NO MEDICATION WAS PRESCRIBED, BUT A SCANNER. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2133666 VERSACROSS CONNECT FOR FARADRIVE CATHETER, SEPTOSTOMY DXF BAYLIS MEDICALE CIE INC 0036584510

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention