BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEBACK CROSSING CATHETER

    MDR report key: 21536076 · Received March 6, 2025

    Report

    Report Number
    3009128730-2025-00001
    Event Type
    Malfunction
    Date Received
    March 6, 2025
    Date of Event
    December 11, 2024
    Report Date
    March 6, 2025
    Manufacturer
    BENTLEY INNOMED GMBH
    Product Code
    PDU
    UDI-DI
    07290017837062
    PMA / PMN Number
    K211802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 THE UK. 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). BASED ON THIS, BENTLEY PERFORMED A CROSS-REPORTING DECISION (ACCORDING TO THE REQUIREMENTS FOR SIMILAR DEVICE MARKETING) FOR THIS COMPLAINT CASE, WHICH OCCURED WITH A DEVICE WITH THE LEGAL MANUFACTURER UPSTREAM WITHIN THE UK, AFTER THE FOLLOWING INVESTIGATION RESULTS BECAME AVAILABLE (ON 03/03/2025), CONFIRMING A USER ERROR: ACCORDING TO "21CFR803.3 (C) CAUSED OR CONTRIBUTED MEANS THAT A DEATH OR SERIOUS INJURY WAS OR MAY HAVE BEEN ATTRIBUTED TO A MEDICAL DEVICE, OR THAT A MEDICAL DEVICE WAS OR MAY HAVE BEEN A FACTOR IN A DEATH OR SERIOUS INJURY, INCLUDING EVENTS OCCURRING AS A RESULT OF: (1) FAILURE, (2) MALFUNCTION, (3) IMPROPER OR INADEQUATE DESIGN, (4) MANUFACTURE, (5) LABELING, OR (6) USER ERROR." BENTLEY HAS DECIDED TO TREAT THIS EVENT AS A MALFUNCTION LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF IT WERE TO RECUR, EVEN THOUGH THE CAUSE IS DETERMINED TO BE THE USER'S NEGLECT TO FOLLOW THE INSTRUCTIONS FOR USE, RATHER THAN A DEFECT IN THE DEVICE, BASED ON "21CFR803.3 (K) MALFUNCTION MEANS THE FAILURE OF A DEVICE TO MEET ITS PERFORMANCE SPECIFICATIONS OR OTHERWISE PERFORM AS INTENDED. PERFORMANCE SPECIFICATIONS INCLUDE ALL CLAIMS MADE IN THE LABELING FOR THE DEVICE. THE INTENDED PERFORMANCE OF A DEVICE REFERS TO THE INTENDED USE FOR WHICH THE DEVICE IS LABELED OR MARKETED." IT WAS REPORTED THAT A "BEBACK USED VIA 6F SHEATH, RIGHT GROIN, CROSSOVER. THE NEEDLE WAS ADVANCED INTO CALCIFICATION AND THE GUIDEWIRE MADE PROGRESS, NEEDLE RETRACTED DURING FURTHER ADVANCEMENT, NEEDLE DEPLOYED AGAIN, 7MM, THIS WAS REPEATED A FEW TIMES AND THE DEVICE MADE ITS WAY THROUGH THE OCCLUSION. THE SURGEON DID TRY TO ROTATE THE DEVICE TO CHANGE THE DIRECTION OF THE NEEDLE, THIS WAS UNSUCCESSFUL. ON DEVICE REMOVAL, THE DISTAL TIP (APPROX 1CM) HAD DETACHED IN THE SHEATH, THIS WAS RETRIEVED WITH THE CURVED NEEDLE INSIDE. IT WAS CONFIRMED THAT THE DISTAL TIP SEPARATED FROM THE DEVICE COMPLETELY." 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 AND SHOWED NO ABNORMALITIES. THE DEVICE LEFT THE MANUFACTURING SITE ACCORDING TO ITS SPECIFICATIONS. THE CLAIMED DEVICE AND THE SEPARATED DISTAL PART OF THE DEVICE (DISTAL TIP / NEEDLE) WERE RETURNED FOR INVESTIGATION. DURING THE INVESTIGATION, IT COULD BE CONFIRMED THAT THE DISTAL PART OF THE SHAFT WAS SEPARATED. THE FRACTURE OF THE DISTAL TIP WAS FURTHER INVESTIGATED. HOWEVER, THE NEEDLE COULD BE PROTRUDED AND RETRACED WITHOUT DIFFICULTIES, EVEN WITHOUT THE SEPARATED DISTAL TIP. NO MALFUNCTION AT THE HANDLE COULD BE DETECTED. IMAGES OF THE COMPLAINT PRODUCT WERE PROVIDED TO UPSTREAM FOR FURTHER INVESTIGATION. THE FRACTURE PROBABLY OCCURRED IN THE INTRODUCER SHEATH CURVATURE. THE CURVATURE CAUSE BENDING FORCES ON THE CATHETER AND NEEDLE. THE NEEDLE PROBABLY WAS ALREADY SEVERELY DAMAGED DUE TO PREVIOUS TORQUE FORCES. TIP-TO SHAFT TEAR IS THE RESULT OF ROTATING THE CATHETER WHILE THE NEEDLE IS PROTRUDED AND STUCK INSIDE THE PLAQUE. ACCORDING TO THE RECEIVED INFORMATION THE USER COMMITTED THAT A HIGH AMOUNT OF FORCE AND TORQUE WAS APPLIED IN ORDER TO CROSS THE OCCLUSION. IT WAS ALSO REPORTED THAT THE DEVICE MIGHT HAVE BEEN TRAPPED IN A CALCIFICATION WHILE THE PHYSICIAN WAS ATTEMPTING TO CHANGE DIRECTION. THIS LED TO THE SEPARATION OF THE CATHETER TIP. THEREFORE, BASED ON THE INFORMATION AVAILABLE AT THIS TIME THE ERROR PATTERN IS CONSIDERED TO HAVE OCCURRED DUE TO A USE ERROR RATHER THAN A MALFUNCTION. ACCORDING TO THE INSTRUCTION FOR USE THE FOLLOWING IS STATED REGARDING THE ROTATION OF THE BEBACK CATHETER (SEE IFU BEBACK #405141 REV.: 2 WARNINGS): "DO NOT ROTATE THE DEVICE INSIDE THE PATIENT BLOOD VESSEL FOR MORE THAN 3 FULL ROTATIONS" FURTHER 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." BASED ON THE OBTAINED RESULTS THE ROOT CAUSE FOR THE UNSATISFYING PERFORMANCE OF THE DEVICE WAS MOST LIKELY AN INADVERTENT ISOLATED HANDLING ERROR. CONCLUSION: DURING THE INVESTIGATION OF THE RETURNED DEVICE, IT COULD BE CONFIRMED THAT THE DISTAL TIP OF THE DEVICE WAS SEPARATED FROM THE CATHETER. IT WAS REPORTED THAT A HIGH AMOUNT OF FORCE AND TORQUE WAS APPLIED IN ORDER TO CROSS THE OCCLUSION. ON THE CATHETER SHAFT OF THE DEVICE CLEAR SIGNS OF TORSION AND KINKING WAS VISIBLE. WHEN OPERATING THE SLIDER THE DEVICE WITHOUT THE DISTAL PART COULD BE OPERATED WITHOUT ANY DIFFICULTIES. THIS LED TO THE SEPARATION OF THE CATHETER TIP. 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.

    Description of Event or Problem · 0

    SERVERE SFA OCCLUSION, SEVERAL ATTEMPRS WITH VARIOUS GUIDEWIRES AND CTO WIRE WERE UNSUCCESSFUL. BEBACK USED VIA 6F SHEATH, RIGHT GROIN, CROSSOVER. THE NEEDLE WAS ADVANCED INTO CALCIFICATION AND THE GUIDEWIRE MADE PROGRESS, NEEDLE RETRACTED DURING FURTHER ADVANCEMENT, NEEDLE DEPLOYED AGAIN, 7MM, THIS WAS REPEATED A FEW TIMES AND THE DEVICE MADE ITS WAY THROUGH THE OCCLUSION. THE SURGEON DID TRY TO ROTATE THE DEVICE TO CHANGE THE DIRECTION OF THE NEEDLE, THIS WAS UNSUCCESSFUL. ON DEVICE REMOVAL, THE DISTAL TIP (APPROX 1CM) HAD DETACHED IN THE SHEATH, THIS WAS RETRIEVED WITH THE CURVED NEEDLE INSIDE. IT WAS CONFIRMED THAT THE DISTAL TIP SEPARATED FROM THE DEVICE COMPLETELY. THE PATIENT HAD A LONG AND TOUGH CTO, THE BEBACK PERFORMED WELL AND PENETRATED THROUGH ULTIMATELY MAKING THE CASE A SUCCESS AFTER A PREVIOUS FAILED INTERVENTION. I THINK THE TIP OF THE DEVICE MAY HAVE BEEN TRAPPED IN CALCIFICATION WHEN THE SURGEOUN WAS ATTEMPTING TO CHANGE DIRECTION, THIS BUILD UP OF TORSION MAY HAVE CAUSED THE DISTAL TIP TO SHEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437625 BEBACK CROSSING CATHETER CROSSING CATHETER PDU BENTLEY INNOMED GMBH FPP600L 198 07290017837062

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown