BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEBACK CROSSING CATHETER

    MDR report key: 23141859 · Received September 25, 2025

    Report

    Report Number
    3009128730-2025-00004
    Event Type
    Malfunction
    Date Received
    September 25, 2025
    Date of Event
    March 20, 2025
    Report Date
    September 25, 2025
    Manufacturer
    BENTLEY INNOMED GMBH
    Product Code
    PDU
    PMA / PMN Number
    K211802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 DISRTIBUTOR. 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 THOGH 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 (CATALOG#, AND LOT# AS PROVIDED WITHIN THIS REPORT). NOTE REGARDING THE DATES PROVIDED IN SECTION D9 AND SECTION G3: THE DEVICE WAS RETURNED TO BENTLEY ON 16-JUL-2025. HOWEVER, IT WAS THEN RETURNED TO UPSTREAM AS THE LEGAL MANUFACTURER FOR THIS SPECIFIC DEVICE AND WAS RECEIVED THERE ON 27-AUG-2025. THEREFORE, THIS DATE IS CHOSEN AS THE DATE OF RETURN TO THE MANUFACTURER WITHIN SECTION D9. THIS COMPLAINT INVESTIGATION WAS PERFORMED IN COOPERATION BY BENTLEY AND UPSTREAM WITH THE RESULTS DISPLAYED FURTHER BELOW BEING ESTABLISHED ON 27-AUG-2025. THEREFORE, THE DATE IN SECTION G3 IS SET TO 27-AUG-2025, SINCE THIS REPRESENTS THE AWARENESS DATE FOR THE NEW INFORMATION.

    Description of Event or Problem · 0

    THE FOLLOWING RELEVANT INFORMATION WAS RECEIVED FROM THE INVOLVED PHYSICIAN BETWEEN THE (B)(6) 2025: "DURING DEVICE PREPARATION THE BEBACK WAS UNPACKED AND ON THE STERILE TABLE. THE MANUAL FUNCTION TEST DID NOT RELEASE THE NEEDLE. PROCEDURE WAS CONTINUED AND COMPLETED WITH A NEW BEBACK DEVICE. NO OTHER MATERIALS AND ACCESSORIES WERE INVOLVED." THE PRODUCT WAS USED WITHIN A FEMORAL SUBINTIMAL RECANALISATION. BASED ON THE REPORTED INFORMATION THIS CASE WAS EVALUATED AS NOT REPORTABLE WITHIN THE INITIAL VIGILANCE ASSESSMENT. THIS COMPLAINT INVESTIGATION WAS PERFORMED IN COOPERATION BY BENTLEY AND UPSTREAM WITH THE RESULTS DISPLAYED FURTHER BELOW BEING ESTABLISHED ON 27-AUG-2025. THEREFORE, THE DATE IN SECTION G3 IS SET TO 27-AUG-2025, SINCE THIS REPRESENTS THE AWARENESS DATE FOR THE NEW INFORMATION. "THE INVESTIGATION WAS CONDUCTED BASED ON THE SUBMITTED INFORMATION, THE RETURNED PRODUCT, THE REVIEW OF THE PRODUCTION DOCUMENTS AS WELL AS ON BENTLEY'S AND UPSTREAM'S MARKET EXPERIENCE AND THE INVESTIGATION RESULTS OF PREVIOUS COMPLAINT CASES. THE REVIEW OF THE PRODUCTION DOCUMENTS WAS PERFORMED BY UPSTREAM AND SHOWED NO ABNORMALITIES. BASED ON THE RESULTS OF THE 100 % FUNCTIONAL TEST AT THE END OF THE CATHETER ASSEMBLY IT CAN BE CONCLUDED THAT THE DEVICE WAS INTACT WHEN IT LEFT THE MANUFACTURING FACILITY. THE CLAIMED BEBACK WAS RETURNED FOR EXAMINATION. DURING EXAMINATION OF THE COMPLAINT PRODUCT A SLIGHT KINK COULD BE CONFIRMED DISTALLY (TOWARDS THE TIP OF THE CATHETER) ON THE SHAFT OF THE DEVICE. ADDITIONALLY TRACES OF BLOOD WERE DETECTED ON THE DEVICE AND ON THE NEEDLE OF THE DEVICE, WHICH INDICATES THAT THE DEVICE WAS USED DURING THE INTERVENTION. DURING THE INVESTIGATION, THE NEEDLE OF THE DEVICE COULD BE PROTRUDED BUT AFTERWARDS IT COULD NOT BE RETRACTED. ONE POSSIBLE EXPLANATION FOR THE CLAIMED INABILITY TO PROTRUDE THE NEEDLE IS THAT THERE WAS AN ATTEMPT TO PUSH THE CATHETER CROSS-OVER INTO THE ILIAC IN A TIGHT ANGLE, WHICH CAUSED THE KINK BEHIND THE RIGID DISTAL TIP. THIS MAY HAVE RESULTED IN THE BREAK OF THE NEEDLE, WHICH IN COMBINATION WITH THE BENT SHAFT OF THE CATHETER PREVENTED THE PROTRUSION OF THE NEEDLE AND LED TO THE EXCHANGE OF THE DEVICE. SINCE DURING THE COMPLAINT INVESTIGATION IT WAS NOT POSSIBLE TO RETRACT THE NEEDLE BACK INTO THE CATHETER THIS WAS ALSO INVESTIGATED. FOR FURTHER EVALUATION THE HANDLE OF THE CLAIMED DEVICE WAS OPENED TO ASSESS A POSSIBLE MALFUNCTION OF THE SLIDER USED TO PROTRUD/RETRACT THE NEEDLE. A SLIDER MALFUNCTION COULD BE EXCLUDED BASED ON THIS ANALYSIS, HOWEVER, A NEEDLE BREAK IN THE DISTAL PART OF THE SHAFT WAS CONFIRMED INSTEAD. THE NEEDLE BREAK WAS LOCATED WITHIN THE SAME AREA WHERE THE SHAFT WAS KINKED. IF THE NEELDE BREAKS AT THIS LOCATION IT REMAINS POSSIBLE TO PROTRUDE IT ONCE BUT IT CAN NO LONGER BE RETRACTED SINCE THE CONNECTION BEWEEN THE PART OF THE NEEDLE THAT IS CONNECTED TO THE SLIDER AND THE DISTAL TIP OF THE NEEDLE IS LOST. THE BENT SHAFT, THE BROKEN NEEDLE AND THE TRACES OF BLOOD FOUND ON THE NEEDLE INDICATE THAT THERE WERE UNUSUAL HIGH FORCES ACTING DURING THE ADVANCEMENT OF THE SYSTEM. THESE FORCES CAN RESULT IN KINKING OF THE CATHETER AND THE NEEDLE, WHICH CAN LEAD TO A BROKEN NEEDLE. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING REGARDING CASES IN WHICH UNUSUAL HIGH RESISTANCE IS FELT (REFER TO FP LABL 0630-REV2, CHAPTER PRECAUTIONS): "CAUTION: THE CATHETER SYSTEM SHOULD NOT BE ADVANCED AGAINST RESISTANCE. THE CAUSE OF THE RESISTANCE SHOULD BE IDENTIFIED AND CORRECTIVE ACTION SHOULD BE TAKEN. IF RESISTANCE IS FELT UPON CATHETER REMOVAL FROM AN ARTERY, CHECK THAT THE NEEDLE TIP IS RETRIEVED INTO THE CATHETER RIGID DISTAL TIP. IF RESISTANCE CONTINUE, THEN THE CATHETER, NEEDLE, GUIDEWIRE, AND THE SHEATH SHOULD BE REMOVED TOGETHER AS A UNIT." SUMMARY AND CONCLUSION: THE REVIEW OF THE PRODUCTION DOCUMENTS WAS PERFORMED BY UPSTREAM AND SHOWED NO ABNORMALITIES. THE DEVICE LEFT ITS MANUFACTURING SITE ACCORDING TO ITS SPECIFICATIONS. DURING EXAMINATION OF THE COMPLAINT PRODUCT A SLIGHT KINK COULD BE CONFIRMED DISTALLY ON THE SHAFT OF THE DEVICE. FURTHERMORE, TRACES OF BLOOD WERE DETECTED ON THE DEVICE AND ON THE NEEDLE OF THE DEVICE. DURING INVESTIGATION, THE NEEDLE OF THE DEVICE COULD BE PROTRUDED BUT IT COULD NOT BE RETRACTED. ONE POSSIBILITY FOR THE CLAIM THAT THE NEEDLE COULD NOT BE PROTRUDED MIGHT BE LINKED TO THE KINK IN THE CATHETER SHAFT, WHICH MAY HAVE PREVENTED THE PROTRUSION OF THE NEEDLE IN A BENT STATE. AFTER DISCOVERING THAT THE NEEDLE COULD NO LONGER BE RETRACTED ONCE PROTRUDED THE FURTHER DEVICE ANALYSIS EXCLUDED A SLIDER MALFUNCTION BUT CONFIRMED A NEEDLE BREAK IN THE DISTAL PART OF THE SHAFT AS A POSSIBLE CAUSE. WHEN THE NEEDLE BREAKS DUE TO E.G. EXCESSIVE USAGE OF THE DEVICE THE NEEDLE CAN STILL BE PROTRUDED IF THE NEEDLE IS STILL INSIDE THE CATHETER. HOWEVER, THE PROTRUDED NEEDLE CAN THEN NO LONGER BE RETRACTED AS THE PART OF THE NEEDLE THAT IS CONNECTED TO THE SLIDER IS NO LONGER CONNECTED TO THE DISTAL PART OF THE NEEDLE. THE DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED BUT BASED ON THE AVAILABLE INFORMATION IT IS ASSUMED THAT MOST PROBABLE ROOT CAUSE WAS THE USAGE OF THE DEVICE IN COMBINATION WITH HIGH PUSHING FORCE THAT BENT THE SHAFT AND RESULTED IN THE BROKEN NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614587 BEBACK CROSSING CATHETER CROSSING CATHETER PDU BENTLEY INNOMED GMBH FPP600L221

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female