BEBACK CROSSING CATHETER
Report
- Report Number
- 3009128730-2025-00005
- Event Type
- Malfunction
- Date Received
- November 21, 2025
- Date of Event
- October 27, 2025
- Report Date
- December 23, 2025
- Manufacturer
- BENTLEY INNOMED GMBH
- Product Code
- PDU
- PMA / PMN Number
- K211802
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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 DISTRIBUTOR. 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 THOUGH 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. WITHIN THE RECEIVED FEEDBACK FROM THE MARKET TWO DEVICES ARE MENTIONED. FOR THE OTHER DEVICE AN ADDITIONAL REPORT (SUBMISSION NAME CC 25-014-1) WILL BE SUBMITTED.
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. WITHIN THE RECEIVED FEEDBACK FROM THE MARKET TWO DEVICES ARE MENTIONED. FOR THE OTHER DEVICE AN ADDITIONAL REPORT (SUBMISSION NAME (B)(4)) WILL BE SUBMITTED.
THE PATIENT IS DOING WELL AND IT APPEARS THAT THE NEEDLE BROKE OFF AND IS STUCK IN THE PATIENT'S BODY. IT WAS A CROSS-OVER INTERVENTION AND A SCARRED VESSEL. BOTH NEEDLE BREAKAGES OCCURRED IN THE SAME PATIENT IN THE SAME TISSUE. THE TISSUE WAS VERY HARD SCAR TISSUE FOLLOWING TEA AND ADDITIONAL SEVERE ARTERIOSCLEROSIS. FIRST PROCEDURE ON (B)(6): CROSSOVER INTERVENTION VIA LONG 6 F FORTRESS SHEATH INTO THE EXTERNAL ILIAC ARTERY. THEN, FROM THE VESSEL STUMP OF THE COMMON FEMORAL ARTERY, A 4 CM LONG OCCLUSION OF THE MAIN TRUNK OF THE PROFUNDA WAS RECANALIZED WITH THE BAD WIRE SIDE AND PREDILATED WITH 3 MM. BE BACK SYSTEM GUIDED TO NEXT TO THE PROFUNDA MAIN TRUNK AND THEN PUNCTURED. NEEDLE GOT STUCK IN THE FIRM TISSUE AND DETACHED FROM THE SYSTEM. THE SYSTEM COULD BE REMOVED WITHOUT ANY PROBLEMS. PATIENT WAS FINE. INTERVENTION NOT SUCCESSFUL, HOWEVER. SECOND PROCEDURE ON (B)(6). REINSERTION OF THE 6 FR CROSSOVER SHEATH. THEN ROADMAP-GUIDED PERIPHERAL PUNCTURE OF THE PROFUNDA FEMORIS ARTERY. 4-F SHEATH. AGAIN SHARP RETROGRADE RECANALIZATION UP TO NEXT TO THE COMMON FEMORAL ARTERY. PRE-DILATED WITH 3 MM. BE BACK SYSTEM GUIDED UP TO NEXT TO THE COMMON FEMORAL ARTERY AND PUNCTURED. THE NEEDLE GOT STUCK AGAIN IN THE FIRM TISSUE AND DETACHED FROM THE SYSTEM. THE SYSTEM COULD BE REMOVED WITHOUT ANY PROBLEMS. REENTRY WAS THEN ACHIEVED THROUGH COMBINED ANTEGRADE AND RETROGRADE MANIPULATION. THE OCCLUSION WAS DILATED AND SUCCESSFULLY TREATED WITH A SUPERA STENT. 2 X COMPLEX DIFFICULT SITUATIONS WITH VERY TOUGH TISSUE. THE NEEDLE WAS LOST TWICE AND REMAINED IN THE PATIENT. BOTH TIMES, THE PATIENT SUFFERED NO HARM. "I HAVE BEEN USING THE BE BACK (FORMERLY GO BACK) SYSTEM FOR A LONG TIME AND KNOW HOW TO USE IT CORRECTLY. AS I SAID, THE FABRIC TO BE PERFORATED WAS VERY HARD. I MOVED THE SLIDER BACK AFTER EACH STITCH WITHOUT TURNING THE SYSTEM. THIS WAS POSSIBLE WITHOUT RESISTANCE. ONLY THE NEEDLE REMAINED STUCK. THE REST OF THE SYSTEM COULD BE REMOVED WITHOUT RESISTANCE."
THE PATIENT IS DOING WELL AND IT APPEARS THAT THE NEEDLE BROKE OFF AND IS STUCK IN THE PATIENT'S BODY. IT WAS A CROSS-OVER INTERVENTION AND A SCARRED VESSEL. BOTH NEEDLE BREAKAGES OCCURRED IN THE SAME PATIENT IN THE SAME TISSUE. THE TISSUE WAS VERY HARD SCAR TISSUE FOLLOWING TEA AND ADDITIONAL SEVERE ARTERIOSCLEROSIS. SECOND PROCEDURE ON (B)(6). REINSERTION OF THE 6 FR CROSSOVER SHEATH. THEN ROADMAP-GUIDED PERIPHERAL PUNCTURE OF THE PROFUNDA FEMORIS ARTERY. 4-F SHEATH. AGAIN SHARP RETROGRADE RECANALIZATION UP TO NEXT TO THE COMMON FEMORAL ARTERY. PRE-DILATED WITH 3 MM. BEBACK SYSTEM GUIDED UP TO NEXT TO THE COMMON FEMORAL ARTERY AND PUNCTURED. THE NEEDLE GOT STUCK AGAIN IN THE FIRM TISSUE AND DETACHED FROM THE SYSTEM. THE SYSTEM COULD BE REMOVED WITHOUT ANY PROBLEMS. REENTRY WAS THEN ACHIEVED THROUGH COMBINED ANTEGRADE AND RETROGRADE MANIPULATION. THE OCCLUSION WAS DILATED AND SUCCESSFULLY TREATED WITH A SUPERA STENT. 2 X COMPLEX DIFFICULT SITUATIONS WITH VERY TOUGH TISSUE. THE NEEDLE WAS LOST TWICE AND REMAINED IN THE PATIENT. BOTH TIMES, THE PATIENT SUFFERED NO HARM. "I HAVE BEEN USING THE BEBACK (FORMERLY GOBACK) SYSTEM FOR A LONG TIME AND KNOW HOW TO USE IT CORRECTLY. AS I SAID, THE FABRIC TO BE PERFORATED WAS VERY HARD. I MOVED THE SLIDER BACK AFTER EACH STITCH WITHOUT TURNING THE SYSTEM. THIS WAS POSSIBLE WITHOUT RESISTANCE. ONLY THE NEEDLE REMAINED STUCK. THE REST OF THE SYSTEM COULD BE REMOVED WITHOUT RESISTANCE." RESULTS OF THE DEVICE EVALUATION: THE REVIEW OF THE PRODUCTION DOCUMENTS WAS PERFORMED BY UPSTREAM AND SHOWED NO ABNORMALITIES. THE INVESTIGATION WAS CONDUCTED BASED ON THE INFORMATION RECEIVED, THE INVESTIGATION RESULTS FROM UPSTREAM, AS WELL AS ON OUR MARKET EXPERIENCE AND THE INVESTIGATION RESULTS OF PREVIOUS COMPLAINT CASES. THE CLAIMED BEBACK DEVICES WERE RETURNED FOR EXAMINATION. DURING INVESTIGATION, IT COULD BE CONFIRMED THAT THE DISTAL PART OF THE NEEDLE WAS SEPARATED ON BOTH DEVICES. IN ADDITION DAMAGES COULD BE CONFIRMED ON THE BRAIDED SHAFT OF THE DEVICE. THIS DAMAGESCONFIRM THE RECEIVED INFORMATION THAT THE DEVICE WAS USED IN A VERY CALCIFIED TISSUE, AS WAS REPORTED WITHIN THE PROVIDED INFORMATION. OTHER THAN THAT NO PLASTIC DEFORMATION (E.G. BENDS OR TWISTS) WERE FOUND ON THE DEVICE. IT WAS REPORTED THAT THE NEEDLES REMAINED INSIDE THE BODY OF THE PATIENT DURING THE INTERVENTION AS COULD BE CONFIRMED WITHIN THE PROVIDED IMAGE DATA. BASED ON UPSTREAM'S AND BENTLEY'S MARKET EXPERIENCE THE NEEDLE OF A BEBACK DEVICE DOES NOT BREAK EASILY, EVEN WHEN PUSHING THE FULLY PROTRUDED NEEDLE FORWARD. TO ASSESS A POSSIBLE INFLUENCE OF NEEDLE WEAKENING IN PRODUCTION TESTS WERE CONDUCTED WITH NEEDLES WELDED WITHIN SPECIFICATION AS WELL AS WITH SIGNIFICANTLY WRONG WELDING PARAMETER. NONE OF THE NEEDLES BROKE, BUT RATHER ALL NEEDLES CAME BACK TO THEIR ORIGINAL SHAPE AFTER REMOVAL OF THE BENDING FORCE. NEEDLE BREAKS WERE ACHIEVED WHEN BENDING THE NEEDLE TO AN ANGLE OF 150 TO 160 DEGREES, WHICH IS DEEMED AS UNREALISTIC DURING CLINICAL USE. THEREFORE, THE INFLUENCE OF THE WELDING PROCESS/WELDING PARAMETERS WAS NOT DEEMED AS A CONTRIBUTING FACTOR. ALL OTHER PRODUCTION STEPS ARE ALSO NOT ASSUMED TO CONTRIBUTE TO NEEDLE BREAKAGE.FURTHERMORE, UPSTREAM PERFORMED ADDITIONAL TESTING TO DETERMINE THE FORCE NEEDED TO BREAK A NEEDLE BY PULLING ON IT, WHICH AMMOUNTED TO ABOUT 90 N WITH A BREAKING POINT BEING IN CLOSE PROXIMITY OF THOSE OF THE CLAIMED DEVICES. THEREFORE, IT IS ASSUMED THAT THE NEEDLE WAS PUSHED FORWARD WITH HIGH FORCES TO PASS THE STIFF SCAR TISSUE, WHICH IN COMBINATION WITH THE REMOVAL OF THE DEVICE LED TO THE BREAKAGE OF THE NEEDLE. IN ORDER TO AVOID THIS PROBLEM, THE IFU OF THE DEVICE STATES THE FOLLOWING (SEE IFU BEBACK #405141 REV.: 2): " WARNING: DO NOT ADVANCE THE BEBACK CATHETER, THE GUIDEWIRE OR ANY OTHER COMPONENT, IF RESISTANCE IS MET, WITHOUT FIRST DETERMINING THE CAUSE AND TAKING CORRECTIVE ACTIONS. PRECAUTION: EXCESSIVE CALCIFICATION AT THE ENTRY SITE MAY IMPAIR PERFORMANCE. CAUTION: THE CATHETER SYSTEM SHOULD NOT BE ADVANCE AGAINST RESISTANCE" DISCUSSION AND CONCLUSION: THE REVIEW OF THE PRODUCTION DOCUMENTS WAS PERFORMED BY UPSTREAM AND SHOWED NO ABNORMALITIES. DURING THE INVESTIGATION OF THE RETURNED DEVICES, IT COULD BE CONFIRMED THAT THE DISTAL PART OF THE NEEDLE WAS SEPARATED FROM THE CATHETER. A PRODUCTION ERROR COULD BE EXCLUDED DURING THE INVESTIGATION. BOTH PRODUCTS SHOW THE EXACT SAME ERROR PATTERN. A HIGHLY CALCIFIED LESION WAS REPORTED WHICH FORCED THE PHYSICIAN TO PERFORM TWO INTERVENTIONS IN ORDER TO CROSS THE OCCLUSION. DURING INVESTIGATION IT COULD BE CONFIRMED THAT AN UNUSUAL AMOUNT OF FORCE WAS MOST PROBABLY APPLIED TO REMOVE THE STUCK NEEDLE OUT OF THE HIGHLY CALCIFIED LESION. IT IS ASSUMED THAT THE PHYSICIAN FIRST PUSHED THE NEEDLE FORWARD VERY STRONGLY IN ORDER TO PASS THE STIFF SCAR TISSUE WHICH IS CLEARLY AGAINST THE IFU. THE ROOT CAUSE CANNOT BE TRACED TO THE CLAIMED DEVICE 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1926596 | BEBACK CROSSING CATHETER | CROSSING CATHETER | PDU | BENTLEY INNOMED GMBH | N/A | FPP600S155 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |