BEBACK CROSSING CATHETER
Report
- Report Number
- 3009128730-2025-00003
- Event Type
- Malfunction
- Date Received
- April 30, 2025
- Date of Event
- April 2, 2025
- Report Date
- June 18, 2025
- Manufacturer
- BENTLEY INNOMED GMBH
- Product Code
- PDU
- PMA / PMN Number
- K211802
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER
- Health Professional
- N
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 ISRAEL. 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. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED WITHIN A FOLLOW-UP REPORT.
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 ISRAEL. 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. THE INVESTIGATION WAS PERFORMED BY ITS LEGAL MANUFACTURER UPSTREAM FOLLOWING THE RECEIPT OF THE DEVICE AND THE INVESTIGATION REPORT WAS PROVIDED TO BENTLEY SUBSEQUENTLY. IT WAS REPORTED THAT THE "NEEDLE OF THE BEBACK BROKE OFF DURING THE PROCEDURE AND REMAINED IN THE POPLITEAL SUBINTIMAL AREA". FURTHER IT WAS REPORTED THAT "THE TIP OF THE NEEDLE WAS LEFT INSIDE THE PATIENT AND THAT IT WAS VERY HARD TO PERFORM THE CROSSOVER." THE NEEDLE BROKE INSIDE THE SUB-INTIMAL SPACE AND COULDN'T BE RETRIEVED WITH A SNARE. THE PATIENT IS DOING WELL. THE INVESTIGATION WAS CONDUCTED BASED ON THE RECEIVED INFORMATION, THE INVESTIGATION RESULTS FROM UPSTREAM, AS WELL AS ON THEIR MARKET EXPERIENCE AND THE INVESTIGATION RESULTS OF PREVIOUS COMPLAINT CASES. WITHIN THE COMPLAINT INVESTIGATION THE FOLLOWING OBSERVATIONS AND CONCLUSIONS WERE MADE: THE DEVICE WAS RETURNED FOR INVESTIGATION. UPON CLOSER INVESTIGATION NO SIGNS OF HIGH TORQUE BUT CLEAR SIGNS OF HIGH PUSHING FORCE WERE DETECTED, AS THE DEVICE IS STRONGLY PLASTICALLY BENDED. THIS COULD HAVE POTENTIALLY CONTRIBUTED TO THE BREAK OF THE NEEDLE TIP. POSSIBLE REASONS ARE: VERY HIGH PUSHING FORCE. NEEDLE WEAKENING OR CRACKING DURING WRONG SPLINE WELDING. TOO HIGH BENDING STRESS DUE TO VERY TIGHT ILIAC. VERY HIGH PUSHING FORCE, MAY COMBINED WITH NEEDLE ROTATION. THE NEEDLE DOES NOT BREAK EASILY, EVEN WHEN PUSHING FULLY PROTRUDED NEEDLE FORWARD. THE INVESTIGATION AND TESTING DONE COULD ONLY POINT FOR EXTREME AXIAL FORCE THAT BREAK THE NEEDLE. NEEDLE FIRST TIME EVER (MORE THAN 20,000 CATHETERS USED) BROKE FROM THE CATHETER TIP WHILE PROTRUDED. SINCE IN THE SUB-INTIMAL SPACE IT IS IMPOSSIBLE TO REMOVE WITH SNARE NO PATIENT INJURY OR HARM PER THE PHYSICIAN, SO HE LEFT IT AS IS. IT IS CLEAR THAT HIGH PUSH FORCE WAS USED, MAYBE TOGETHER WITH NEEDLE TORQUING. FURTHER THE INSTRUCTION FOR USE STATES THE FOLLOWING REGARDING RESISTANCE DURING USE OF THE DEVICE WITH A PROTRUDED NEEDLE (SEE IFU BEBACK #405141 REV.: 2 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." WITHIN THE ADDITIONALLY OPENED CAPA 049 THE FOLLOWING FURTHER RESULTS WERE GATHERED: THE BROKEN NEEDLE MAY BE DUE TO VERY HIGH PUSH FORCES APPLIED AS CAN BE SEEN BY THE PLASTIC DEFORMATION OF THE CATHETER DISTAL 30 CM. SUCH HIGH PUSH FORCES WERE MAYBE COMBINED WITH NEEDLE TORQUEING THAT CONTRIBUTES TO THE NEEDLE BREAK. ANOTHER POSSIBLE ROOT CAUSE COULD BE THE COMBINATION OF SUCH HIGH FORCE AND DAMAGE / WEAKENING IN THE NEEDLE TUBE DUE TO PULSE SPLINE WELDING. SUCH DAMAGES COULD HAVE CONTRIBUTED TO THE BREAKAGE UNDER SUCH HIGH PUSH FORCE SINCE THE FAILURE WAS RIGHT AT THE SPLINE WELDING. TO FURTHER INVESTIGATE THIS POSSIBLE ROOT CAUSE, NEEDLES PRODUCED WITH BOTH, NOMINAL PARAMETERS AND WITH WELDING PARAMETERS OUT OF SPECIFICATION. BENDING FORCE WAS APPLIED ON THE NEEDLE UP TO 90 DEGREES FROM THE ORIGINAL POSITION, WHILE MEASURING THE BENDING FORCE AND CHECKING FOR NEEDLE BREAK OR CRACK. NONE OF THE PREPARED NEEDLES BROKE OR CRACKED AND ALL CAME BACK TO THE ORIGINAL SHAPE AFTER THE BENDING FORCE WAS REMOVED. NEEDLE BREAKS COULD ONLY BE SIMULATED WHILE BENDING THE NEEDLE TO AN ANGLE OF ABOUT 150-160 DEGREES, WHICH IS DEEMED UNREALISTIC DURING CLINICAL USE. THEREFORE, THE WELDING PARAMETERS DID NOT AFFECT THE NEEDLE TIP STRENGTH AND CANNOT BE CONSIDERED AS A FACTOR CONTRIBUTING TO THE NEEDLE BREAK AND ARE THUS EXCLUDED AS A POSSIBLE ROOT CAUSE. NO OTHER PRODUCTION STEP IS ASSUMED AS POTENTIAL ROOT CAUSE TO THIS ERROR PATTERN. BASED ON THE OBTAINED RESULTS THE ROOT CAUSE FOR THE UNSATISFYING PERFORMANCE OF THE DEVICE WAS MOST LIKELY AN INADVERTENT ISOLATED HANDLING ERROR IN COMBINATION WITH THE TIGHT ILIAC ARCH. SUMMARY AND CONCLUSION: THE REVIEW OF THE PRODUCTION DOCUMENTS COULD NOT BE CARRIED OUT BY UPSTREAM AS THE INFORMATION REGARDING THE LOT NUMBER WAS NOT PROVIDED. DURING THE INVESTIGATION OF THE RETURNED DEVICE, IT COULD BE CONFIRMED THAT THE DISTAL PART OF THE NEEDLE WAS SEPARATED FROM THE CATHETER. DURING INVESTIGATION IT COULD BE CONFIRMED THAT A HIGH AMOUNT OF FORCE WAS APPLIED AGAINST RESISTANCE IN ORDER TO CROSS THE OCCLUSION. FURTHER A PRODUCTION ERROR COULD BE EXCLUDED DURING THE INVESTIGATION. ON THE CATHETER SHAFT OF THE DEVICE CLEAR SIGNS OF STRONG PUSHING FORCE AND KINKING WAS VISIBLE. IT IS THEREFORE ASSUMED THAT THIS ERROR PATTERN OCCURRED DUE TO WEAKENING OF THE NEEDLE DURING THE INTERVENTION. THE ROOT CAUSE CANNOT BE TRACED TO THE CLAIMED DEVICE BUT RATHER TO A HANDLING FAILURE DURING THE INTERVENTION. THUS, A DEVICE MALFUNCTION CANNOT BE CONFIRMED AND NO FURTHER ACTIONS ARE NECESSARY BY BENTLEY.
THE FOLLOWING INFORMATION WAS RECEIVED BY BENTLEY ON 02-APR-2025: "DURING THE PROCEDURE, THE TIP OF THE NEEDLE DETACHED FROM THE CATHETER AND REMAINED IN THE POPLITEAL SUBINTIMAL AREA. THE TIP OF THE NEEDLE OF THE BEBACK BROKE OFF DURING THE PROCEDURE AND UNFORTUNATELY WAS LEFT INSIDE THE PATIENT. AT THE MOMENT THE PATIENT IS DOING WELL AND FURTHER INFORMATION WILL BE REQUESTED BY OUR PARTNER (CC) AT THE PHYSICIAN THAT PERFORMED THIS PROCEDURE TODAY." FURTHER INFORMATION WAS RECEIVED ON 08-APR-2025 "IN THIS CASE THE NEEDLE BROKE FROM UNKNOWN REASON. ALL WE KNOW ABOUT THE CASE IS THAT IT WAS A VERY TIGHT ILIAC ARCH, HARD TO CROSS AND TO PUSH. HOWEVER THE PHYSICIAN CLAIM HE DIDN'T ROTATE THE NEEDLE ITSELF. WE GOT THE DEVICE BACK FROM THE HOSPITAL IN ISRAEL AND CHECKED IT. INDEED THE NEEDLE TIP IS MISSING. BROKE DISTALLY TO THE SPLINE. THE CATHETER HAVE SHARP PLASTIC BENDING ALONG THE FIRST 30CM LENGTH, LIKE A LOOP, INDICATE HIGH PUSHING FORCES WERE USED."
THE FOLLOWING INFORMATION WAS RECEIVED BY BENTLEY ON 02-APR-2025: "DURING THE PROCEDURE, THE TIP OF THE NEEDLE DETACHED FROM THE CATHETER AND REMAINED IN THE POPLITEAL SUBINTIMAL AREA. THE TIP OF THE NEEDLE OF THE BEBACK BROKE OFF DURING THE PROCEDURE AND UNFORTUNATELY WAS LEFT INSIDE THE PATIENT. AT THE MOMENT THE PATIENT IS DOING WELL AND FURTHER INFORMATION WILL BE REQUESTED BY OUR PARTNER (CC) AT THE PHYSICIAN THAT PERFORMED THIS PROCEDURE TODAY." FURTHER INFORMATION WAS RECEIVED ON 08-APR-2025. "IN THIS CASE THE NEEDLE BROKE FROM UNKNOWN REASON. ALL WE KNOW ABOUT THE CASE IS THAT IT WAS A VERY TIGHT ILIAC ARCH, HARD TO CROSS AND TO PUSH. HOWEVER THE PHYSICIAN CLAIM HE DIDN'T ROTATE THE NEEDLE ITSELF. WE GOT THE DEVICE BACK FROM THE HOSPITAL IN ISRAEL AND CHECKED IT. INDEED THE NEEDLE TIP IS MISSING. BROKE DISTALLY TO THE SPLINE. THE CATHETER HAVE SHARP PLASTIC BENDING ALONG THE FIRST 30CM LENGTH, LIKE A LOOP, INDICATE HIGH PUSHING FORCES WERE USED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1757560 | BEBACK CROSSING CATHETER | CROSSING CATHETER | PDU | BENTLEY INNOMED GMBH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |