BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEBACK CROSSING CATHETER

    MDR report key: 20890993 · Received December 10, 2024

    Report

    Report Number
    3009128730-2024-00002
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    November 20, 2024
    Report Date
    January 17, 2025
    Manufacturer
    BENTLEY INNOMED GMBH
    Product Code
    PDU
    PMA / PMN Number
    K211802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE PRODUCTION DOCUMENTS WAS PERFORMED BY UPSTREAM AND SHOWED NO ABNORMALITIES. THE DEVICE INVESTIGATION WAS PERFORMED IN COOPERATION BY BENTLEY AND UPSTREAM. IN THE COMPLAINT DESCRIPTION IT WAS STATED THAT "THE NEEDLE GOT STUCK IN THE DEPLOYED POSITION AND WE WERE NOT ABLE TO RETRACT IT". NO HARM TO THE PATIENT WAS REPORTED. THE INVESTIGATION WAS CONDUCTED BASED ON THE SUBMITTED INFORMATION, THE RETURNED PRODUCT AS WELL AS ON OUR MARKET EXPERIENCE AND THE INVESTIGATION RESULTS OF PREVIOUS COMPLAINT CASES. THE COMPLAINT PRODUCT WAS RETURNED FOR EXAMINATION. TRACES OF BLOOD COULD BE CONFIRMED ON THE DEVICE. AFTER EXAMINATION OF THE COMPLAINT PRODUCT THE REPORTED DEFECT PATTERN COULD BE CONFIRMED. AS REPORTED, THE NEEDLE WAS PROTRUDED AND COULD NOT BE RETRACTED WITH THE SLIDER OF THE DEVICE. WHEN OPERATING THE SLIDER SOME KIND OF FRICTION COULD BE CONFIRMED. AFTER EXAMINATING THE PRODUCT FURTHER SIGNS OF SEVERE TORSION COULD BE CONFIRMED ON SEVERAL AREAS OF CATHETER SHAFT. FURTHER, IT COULD BE CONFIRMED THAT TENSION BUILD UP IN THE TORQUED AREAS OF THE DEVICE WHEN OPERATING THE SLIDER. ADDITIONALLY, A SMALL KINK AT ABOUT IN THE MIDDLE OF THE CATHETER WAS VISIBLE WHILE OPERATING THE SLIDER. AFTER THE EXAMINATION OF THE DEVICE, IT IS ASSUMED THAT THE DEVICE WAS UNDER HIGH TORQUE AND HIGH PUSH AT THE SAME TIME, WHILE THE NEEDLE WAS PROTRUDED. AFTER CUTTING THE KINKED SEGMENT, THE NEEDLE COULD BE RETRIEVED INTO THE TIP, AND THE HANDLE SLIDER MOVED FREELY. BASED ON OUR EXPERIENCE THE BRAIDED SHAFT GETS DAMAGED WHEN ROTATING THE NEEDLE AGAINST RESISTANCE. THE BRAIDED SHAFT IS FIRMLY CONNECTED WITH THE DISTAL PART OF THE DEVICE. THEREFORE WHEN THE NEEDLE IS STUCK IN A CALCIFICATION AND THE DEVICE IS ROTATED THE TORQUE IMPACTS THE BRAIDED SHAFT. ROTATING THE CATHETER WHILE THE NEEDLE IS PROTRUDED AND STUCK IN A CALCIFICATION, CAN THEREFORE CAUSE A DAMAGE ON THE BRAIDED SHAFT AND IN THE WORST CASE CAN CAUSE INJURIES TO THE PATIENT IF THE PROTRUDED NEEDLE DECOUPLES OF THE CALCIFICATION WHILE ROTATING, E.G. VESSEL DISSECTION. BASED ON THE INVESTIGATION RESULTS IT IS ASSUMED THAT THE NEEDLE COULDN'T BE RETRACTED AND WAS BLOCKED BECAUSE OF THE SEVERE TORQUED CATHETER. THE INSTRUCTION FOR USE STATES THE FOLLOWING REGARDING ROTATION OF THE DEVICE WITH A PROTRUDED NEEDLE (SEE IFU BEBACK #405141 REV.: 2 PRECAUTIONS): "DO NOT ROTATE THE CATHETER WHILE NEEDLE IS PROTRUDED AND STUCK INSIDE HARD PLAQUE." IF THE IFU IS NOT FOLLOWED CAREFULLY, THE POTENTIAL COMPLICATIONS THAT CAN OCCUR ARE LISTED IN THE IFU OF THE BEBACK: "POTENTIAL ADVERSE EVENTS INCLUDE, BUT ARE NOT LIMITED TO: VESSEL DISSECTION, INJURY, PSEUDOANEURYSM, HEMORRHAGE AND ISCHEMIA." DISCUSSION AND CONCLUSION OF THE DEVICE INVESTIGATION DURING THE INVESTIGATION OF THE RETURNED DEVICE, IT COULD BE CONFIRMED THAT THE NEEDLE OF THE DEVICE COULD NOT BE RETRACTED. ON THE CATHETER SHAFT OF THE DEVICE CLEAR SIGNS OF TORSION AND A SLIGHT KINK COULD BE CONFIRMED. WHEN OPERATING THE SLIDER OF THE DEVICE IT WAS VISIBLE THAT TENSION BUILD UP ON THE DAMAGED PARTS OF THE CATHETER SHAFT. THE BRAIDED SHAFT IS FIRMLY CONNECTED WITH THE DISTAL PART OF THE DEVICE. THEREFORE, WHEN THE NEEDLE IS STUCK IN E.G. A CALCIFICATION AND THE DEVICE IS ROTATED THE TORQUE IMPACTS THE BRAIDED SHAFT. ROTATING THE CATHETER WHILE THE NEEDLE IS PROTRUDED AND STUCK IN A CALCIFICATION, CAN THEREFORE CAUSE A DAMAGE ON THE BRAIDED SHAFT AND IN THE WORST CASE CAN CAUSE INJURIES TO THE PATIENT IF THE PROTRUDED NEEDLE DECOUPLES OF THE CALCIFICATION WHILE ROTATING, E.G. VESSEL DISSECTION. THE ROOT CAUSE CANNOT BE TRACED TO THE CLAIMED PRODUCT BUT RATHER TO A NEGLECT OF THE IFU. THUS, A DEVICE MALFUNCTION CANNOT BE CONFIRMED AND NO FURTHER ACTIONS (E.G. INITIATION OF A CAPA) ARE NECESSARY.

    Additional Manufacturer Narrative · 0

    THE PRODUCTION DOCUMENTATION AS WELL AS THE DEVICE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 0

    COMPLAINT DESCRIPTION: THE NEEDLE GOT STUCK IN THE DEPLOYED POSITION. THE NEEDLE GOT STUCK IN THE DEPLOYED POSITION AND WE WERE NOT ABLE TO RETRACT IT. IN THE VOICEMAIL IT WAS NOT SPECIFIED IF THE PRODUCT WAS INTENDED TO BE RETURNED. NO MEDICAL/SURGICAL INTERVENTION PERFORMED BUT ADDITIONALLY NOT ALL FIELD COULD BE FILLED OUT DUE TO LIMITED INFORMATION.

    Description of Event or Problem · 0

    COMPLAINT DESCRIPTION: THE NEEDLE GOT STUCK IN THE DEPLOYED POSITION. THE NEEDLE GOT STUCK IN THE DEPLOYED POSITION AND WE WERE NOT ABLE TO RETRACT IT. IN THE VOICEMAIL IT WAS NOT SPECIFIED IF THE PRODUCT WAS INTENDED TO BE RETURNED. NO MEDICAL/SURGICAL INTERVENTION PERFORMED BUT ADDITIONALLY NOT ALL FIELD COULD BE FILLED OUT DUE TO LIMITED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504866 BEBACK CROSSING CATHETER CROSSING CATHETER PDU BENTLEY INNOMED GMBH FPP603L053

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other