BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEBACK CROSSING CATHETER

    MDR report key: 24954558 · Received April 22, 2026

    Report

    Report Number
    3009128730-2026-00002
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    March 9, 2026
    Report Date
    April 22, 2026
    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

    BASED ON THE INFORMATION INITIALLY AVAILABLE 17-MAR-2026, THE EVENT WAS ASSESSED AS NON-REPORTABLE. UPON COMPLETION OF FURTHER INVESTIGATION (DEVICE RECEIVED ON 27-MAR-2026) AND RECEIPT OF ADDITIONAL INFORMATION, THE EVENT WAS RE-EVALUATED AND FULLFILLED THE REPORTING CRITERIA. THEREFORE, THIS REPORT IS SUBMITTED WITHIN 30 DAYS OF AWARENESS OF REPORTABILITY. FINAL DECISION (B)(6) 2026 AFTER DEVICE INVESTIGATION THE REVIEW OF THE PRODUCTION DOCUMENTS WAS PERFORMED BY UPSTREAM AND SHOWED NO ABNORMALITIES. DURING EXAMINATION OF THE COMPLAINT PRODUCT IT COULD BE CONFIRMED THAT THE NEEDLE COULD NOT BE PROTRUDED INITIALLY BUT AFTER STRAIGHTENING THE DISTAL TIP OF THE PRODUCT THE PROTRUSION SUCCEEDED. THE PROTRUDED NEEDLE COULD NOT BE RETRACTED. A BREAKAGE OF THE NEEDLE COULD BE CONFIRMED PROXIMAL TO THE SPLINE. THE DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED BUT BASED ON THE AVAILABLE INFORMATION IT IS ASSUMED THAT DUE TO THE KINK ON THE DISTAL PART OF THE DEVICE THE MOST PROBABLE ROOT CAUSE WAS THE USAGE OF THE DEVICE WITH HIGH PUSHING FORCE OR A TIGHT ANGLE DURING THE ADVANCEMENT TO THE TARGET LESION. AS THE NEEDLE WAS NOT PROTRUDED DURING RECEIVAL OF THE COMPLAINT DEVICE AND IT WAS REPORTED THAT THE NEEDLE COULD NOT BE PROTRUDED, WHICH WAS CONFIRMED DURING INVESTIGATION, IT IS ASSUMED THAT THE NEEDLE BREAKAGE OCCURRED AS THE NEEDLE WAS NOT PROTRUDED. NEVERTHELESS, A HANDLING FAILURE DURING THE PREPARATION OF THE DEVICE CANNOT BE RULED OUT. THE REPORTED DAMAGE ON THE GUIDEWIRE COATING WAS MOST PROBABLY CAUSED BY POTENTIAL SHARP EDGES DUE TO THE BREAKAGE OF THE NEEDLE. A DEVICE MALFUNCTION OF THE PRODUCT CANNOT BE CONFIRMED AND THUS NO FURTHER ACTIONS (E.G. CAPA) ARE NECESSARY. 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 WITHIN THIS REPORT.

    Description of Event or Problem · 0

    INFORMATION RECEIVED ON 23-MAR-2026: NEEDLE COULD NOT BE FULLY RETRACTED IN DEVICE SINCE THE BEGINNING AND DAMGES THE WIRE-COATING. FETRESS SHEATH 6.5. ADVANTAGE WIRE 0.018. INFORMATION RECEIVED ON 31-MAR-2026: · WAS THE PRODUCT INSERTED INTO THE BODY? YES. · OR AT WHAT EXACT POINT WAS THE GUIDEWIRE DAMAGED? INSERTION OF THE WIRE WAS POSSIBLE WITHOUT ANY PROBLEMS; HOWEVER, ADVANCING THE SYSTEM OVER THE WIRE WAS ONLY POSSIBLE WITH RESISTANCE. UPON WITHDRAWAL OF THE WIRE, THE WIRE BECAME LODGED IN THE SYSTEM, MEANING THE SYSTEM HAD TO BE REMOVED TOGETHER WITH THE WIRE. A REPEAT ATTEMPT WITH A NEW WIRE YIELDED THE SAME RESULT. · WHAT EXACTLY IS MEANT BY "NEEDLE COULD NOT BE FULLY RETRACTED IN DEVICE"? THE NEEDLE WAS NOT ADVANCED AND REMAINED IN THE SAFETY POSITION AT ALL TIMES; HOWEVER, IT APPEARED THAT THE NEEDLE REACHED THE OSTIUM OF THE SYSTEM. · WAS THE NEEDLE ALREADY PROTRUDING UPON INSERTION, OR COULD THE NEEDLE NO LONGER BE RETRACTED AFTER INSERTION? THE SAFETY LOCK WAS NOT RELEASED AND THE NEEDLE WAS NOT ADVANCED, AS THE TARGET LESION WAS NOT REACHED. WITH A NEW BEBACK-SYSTEM, THIS WAS THEN POSSIBLE WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272700 BEBACK CROSSING CATHETER Catheter for crossing total occlusions PDU BENTLEY INNOMED GMBH BG600018P120L FPP600L200

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male