BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEBACK CROSSING CATHETER

    MDR report key: 20890593 · Received December 10, 2024

    Report

    Report Number
    3009128730-2024-00003
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    November 14, 2024
    Report Date
    February 13, 2025
    Manufacturer
    BENTLEY INNOMED GMBH
    Product Code
    PDU
    PMA / PMN Number
    K211802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING DEVICE PREPARATION "TRIED TO PUT NEEDLE INTO 2ND POSITION (7MM) THROW AND GOT STUCK WOULD NOT RETRACT BACK IN, WAS JUST TESTING SYSTEM ON BACK TABLE AND DID NOT ENTER IT INTO PATIENT AT ALL." THE INVESTIGATION WAS CONDUCTED BASED ON THE RECEIVED INFORMATION, THE RETURNED PRODUCT, AS WELL AS ON OUR MARKET EXPERIENCE AND THE INVESTIGATION RESULTS OF PREVIOUS COMPLAINT CASES. THE REVIEW OF THE PRODUCTION DOCUMENTS WAS PERFORMED BY UPSTREAM (CONTRACT MANUFACTURER) AND SHOWED NO ABNORMALITIES. THE DEVICE LEFT THE MANUFACTURING SITE ACCORDING TO ITS SPECIFICATIONS. A FURTHER COMPLAINT CASE ((B)(4)) OCCURRED WHERE THE SAME LOT WAS AFFECTED AS IN THE CURRENT CASE. WITHIN THIS COMPLAINT CASE A DIFFERENT ERROR PATTERN (NEEDLE COULD NOT BE PROTRUDED) WAS REPORTED AND THEREFORE, A LINK BETWEEN THE COMPLAINTS COULD BE EXCLUDED. IN GENERAL, THE DISTAL TIP AND THE DISTAL TIP TUBE ARE CONNECTED VIA AN ADHESIVE. DURING THE INVESTIGATION, IT WAS DETECTED THAT THE DISTAL TIP TUBE TOGETHER WITH THE ADHESIVELY CONNECTED DISTAL TIP SLIPPED DISTALLY OVER THE PROTRUDED NEEDLE OF THE DEVICE. FURTHERMORE, IT COULD BE CONFIRMED THAT THE BRAIDED SHAFT OF THE DEVICE WAS DISCONNECTED FROM THE DISTAL TIP (SEE FIGURE 2 AND FIGURE 3). BOTH, THE DISTAL TIP TOGETHER WITH THE ADHESIVELY CONNECTED DISTAL TIP TUBE WERE FULLY OUTSIDE OF THE BRAIDED SHAFT. USUALLY, THE BRAIDED SHAFT HAS AN ADHESIVE CONNECTION TO THE DISTAL TIP SO THAT THE NEEDLE CAN BE PROTRUDED AND RETRACTED WITHOUT MOVEMENT OF THE DISTAL TIP. IN THIS CASE, THE ADHESIVE CONNECTION BETWEEN THE BRAIDED SHAFT AND THE DISTAL TIP FAILED DURING THE DEVICE PREPARATION, WHICH RESULTED IN THE DISCONNECTION OF THE BRAIDED SHAFT AND THE DISTAL TIP. SINCE THE DISTAL TIP WAS THEN NO LONGER CONNECTED TO THE BRAIDED SHAFT OF THE DEVICE IT MOVED FORWARD TOGETHER WITH THE NEEDLE DURING THE DEVICE PREPARATION. IMPORTANTLY, THE DISTAL TIP AND THE CONNECTED DISTAL TIP TUBE CANNOT FULLY DISLOCATE FROM THE BEBACK CROSSING CATHETER, SINCE THIS IS PREVENTED BY THE SPLINE, WHICH FIXATES THE DISTAL TIP TUBE TO THE NEEDLE. HOWEVER, RETRACTING THE NEEDLE WAS NOT POSSIBLE, SINCE THE DISTAL TIP TUBE WAS POSITIONED IN AN ANGLE, WHICH PREVENTED A RETRACTION BACK INTO THE BRAIDED SHAFT. IN ADDITION, THE IMAGES MADE DURING THIS INVESTIGATION WERE PROVIDED TO UPSTREAM FOR FURTHER INVESTIGATION. THE INVESTIGATION RESULTS FROM UPSTREAM SUPPORTED THE CONCLUSION THAT THE DEFECT PATTERN OCCURRED DUE TO A FAILURE OF THE ADHESIVE CONNECTION BETWEEN THE DISTAL TIP AND THE BRAIDED SHAFT. THE DISTAL TIP WAS SEPARATED FROM THE BRAIDED SHAFT AND MOVED FORWARD AND BACKWARD TOGETHER WITH THE NEEDLE. BASED ON THE INVESTIGATION OF UPSTREAM THE ROOT CAUSE COULD BE TRACED TO AN INSUFFICIENT AMOUNT OF ADHESIVE BEING USED TO CONNECT BOTH PARTS. THE FINAL RELEASE TEST IS A 100 % CONTROL IN WHICH THE NEEDLE IS PROTRUDED AND RETRACTED. FURTHERMORE, THE DISTAL TIP IS MANUALLY PULLED IN EACH MANUFACTURED GOOD. HOWEVER, FOR THIS CASE IT IS POSSIBLE, THAT ENOUGH GLUE WAS USED FOR THE CONNECTION THAT THE CLAIMED PRODUCT PASSED THE FINAL RELEASE TEST BUT FAILED DURING THE DEVICE PREPARATION. IN CONCLUSION, A DEVICE MALFUNCTION OF THE BEBACK CATHETER COULD BE CONFIRMED. THE ROOT CAUSE FOR THIS COMPLAINT CASE WAS DETERMINED AS A HUMAN ERROR DURING PRODUCTION PROCESS AT UPSTREAM (CONTRACT MANUFACTURER). BASED ON THE RESULTS OF THIS INVESTIGATION CAPA 048 WAS INITIATED AT UPSTREAM TO IMPLEMENT FURTHER RISK MITIGATION MEASURES. SINCE A DEVICE MALFUNCTION WAS CONFIRMED THE NON-CONFORMANCE NC 25-005 WAS INITIATED AND THE RISK ASSOCIATED WITH THIS ERROR PATTERN FOR THE PRODUCTS IN THE FIELD WAS ASSESSED. IN CONCLUSION THE RISK FOR THE PRODUCTS ON THE FIELD WAS DEEMED AS ACCEPTABLE BASED ON THE UNDERLYING RISK MANAGEMENT FILE.

    Additional Manufacturer Narrative · 0

    PRODUCTION DOCUMENTATION WILL BE REVIEWED AND THE DEVICE INVESTIGATED IF RETURNED.

    Description of Event or Problem · 0

    COMPLAINT DESCRIPTION: WAS NOT PRESENT FOR CASE- SUPPOSEDLY WENT TO PREP DEVICE AND TRIED TO PUT NEEDLE INTO 2ND POSITION (7MM) THROW AND GOT STUCK WOULD NOT RETRACT BACK IN, WAS JUST TESTING SYSTEM ON BACK TABLE AND DID NOT ENTER IT INTO PATIENT AT ALL.

    Description of Event or Problem · 0

    COMPLAINT DESCRIPTION: WAS NOT PRESENT FOR CASE- SUPPOSEDLY WENT TO PREP DEVICE AND TRIED TO PUT NEEDLE INTO 2ND POSITION (7MM) THROW AND GOT STUCK WOULD NOT RETRACT BACK IN, WAS JUST TESTING SYSTEM ON BACK TABLE AND DID NOT ENTER IT INTO PATIENT AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711332 BEBACK CROSSING CATHETER CROSSING CATHETER PDU BENTLEY INNOMED GMBH FPP600L145

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other