BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEBACK CROSSING CATHETER

    MDR report key: 23875661 · Received December 23, 2025

    Report

    Report Number
    3009128730-2025-00007
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    September 11, 2025
    Report Date
    December 23, 2025
    Manufacturer
    BENTLEY INNOMED GMBH
    Product Code
    PDU
    PMA / PMN Number
    K211802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION OF THE LEGAL RELATIONSHIPS (RESPONSIBILITIES) OF THE COMPANIES INVOLVED IN RELATION TO THE REPORTED PRODUCT, PROVIDED IN ADVANCE: THIS COMPLAINT CASE WAS REPORTED TO BENTLEY INNOMED GMBH AS THE EXCLUSIVE DISTRIBUTOR OF THE CLAIMED DEVICE AND THE EVENT OCCURED IN GERMANY. FOR THIS DEVICE OUTSIDE THE USA UPSTREAM PERIPHERAL TECHNOLOGIES LTD. IS THE LEGAL MANUFACTURER AND BENTLEY INNOMED GMBH IS THE EXCLUSIVE DISTRIBUTOR. HOWEVER, BENTLEY INNOMED GMBH IS THE MANUFACTURER (SPECIFICATION DEVELOPER) OF A SIMILAR DEVICE WITHIN THE USA 510(K):K211802 AND HAS THE CONTRACT MANUFACTURER UPSTREAM PERIPHERAL TECHNOLOGIES LTD. THUS, BENTLEY HAS ENTERED ITS OWN DATA TO THE MANUFACTURER SECTION AND THE DATA OF UPSTREAM TO THE CONTRACT MANUFACTURERS SECTION EVEN THOUGH FOR THE AFFECTED DEVICE ITSELF (AS NON US DEVICE) UPSTREAM IS THE LEGAL MANUFACTURER. THE PROVIDED 510(K): K211802 IS THUS NOT DIRECTLY RELATED TO THE REFERENCED PRODUCT WITHIN THIS REPORT. FURTHER INFORMATION: WE RECEIVED THE INITIAL INFORMATION ABOUT THIS CASE ON SEPTEMBER 22, 2025. BASED ON THE INFORMATION AVAILABLE AT THAT TIME, THE INCIDENT WAS CLASSIFIED AS NOT REPORTABLE IN ACCORDANCE WITH APPLICABLE REGULATIONS. AFTER COMPLETING THE PRODUCT INVESTIGATION AND RECEIVING ADDITIONAL INFORMATION ON DECEMBER 1, 2025, NEW FINDINGS WERE OBTAINED. BASED ON THESE ADDITIONAL DETAILS, THE INCIDENT WAS REASSESSED AND CLASSIFIED AS REPORTABLE IN ACCORDANCE WITH LEGAL REQUIREMENTS.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINT DESCRIPTION, THE BEBACK DEVICE WAS INSERTED INTO THE PATIENT AND THE NEEDLE WAS REMOVED AND REINSERTED SEVERAL TIMES (ABOUT THREE TIMES) WITHOUT ANY ISSUES. REINSERTION OF THE NEEDLE WAS POSSIBLE WITHOUT DIFFICULTY DURING THESE STEPS. SUBSEQUENTLY, THE BEBACK DEVICE WAS REMOVED FROM THE PATIENT. OUTSIDE THE PATIENT, THE NEEDLE WAS REMOVED IN ORDER TO TEST THE DEVICE. AT THAT TIME, THE BEBACK WAS NOT POSITIONED ON A GUIDEWIRE. FOLLOWING THIS STEP, REINSERTION OF THE NEEDLE WAS NO LONGER POSSIBLE. AS A RESULT, THE DEVICE WAS NOT REUSED AND WAS NOT REINSERTED INTO THE PATIENT. FURTHER DETAILED INFORMATION: THIS WAS A SUPERFICIAL FEMORAL CROSSOVER RECANALIZATION PROCEDURE. WE INSERTED THE BEBACK INTO THE PATIENT AND REMOVED THE NEEDLE SEVERAL TIMES (ABOUT THREE TIMES) WITHOUT ANY PROBLEMS. WE WERE ABLE TO REINSERT IT WITHOUT ANY ISSUES. WE THEN REMOVED THE BEBACK FROM THE PATIENT. ONCE OUTSIDE THE PATIENT, WE REMOVED THE NEEDLE TO TEST IT. THE BEBACK WAS NOT ON A GUIDEWIRE AT THAT POINT. WE WERE THEN UNABLE TO REINSERT THE NEEDLE AND THEREFORE DID NOT REUSE THE DEVICE; IT WAS NOT REINSERTED INTO THE PATIENT. HE COMPLAINED ABOUT THE REINSERTION OF THE GUIDEWIRE. -> WE DID NOT REINSERT THE GUIDEWIRE AFTER THE NEEDLE BECAME STUCK. DID THE DOCTOR TRY TO REINSERT THE GUIDEWIRE THROUGH A PROTRUDING NEEDLE? NO DID HE NOTICE THAT THE NEEDLE COULD NOT BE REMOVED? WAS THE NEEDLE PROTRUDING WHEN HE TRIED TO REINSERT IT? WE DID NOT REINSERT THE BEBACK ONCE THE NEEDLE WAS STUCK IN THE PROTRUDING POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2702258 BEBACK CROSSING CATHETER Catheter for crossing total occlusions PDU BENTLEY INNOMED GMBH FPP600S155

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Unknown