Benchmark BMK6F105MBER130Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00814548014050), received between Oct 27, 2015 and Jul 22, 2024 — classified as 2 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (10 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NEURON SELECT CATHETER 5F (5F SELECT), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BENCHMARK AND THE 5F SELECT TO THE TARGET LOCATION. AFTER PLACING THE BENCHMARK INTO THE TARGET LOCATION, THE 5F SELECT WAS REMOVED. WHILE ASPIRATING THE BENCHMARK USING A 20CC SYRINGE TO ENSURE THERE IS NO AIR, THE PHYSICIAN NOTICED THAT THE BENCHMARK WAS FRACTURED AT THE PROXIMAL END. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER BENCHMARK, ANOTHER 5F SELECT, AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19795420 ↗
• MalfunctionMay 19, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT VERTEBRAL ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE BENCHMARK OVER A GUIDEWIRE TO THE TARGET VESSEL DUE TO THE PATIENT¿S ANATOMY BEING DIFFICULT WITH ELONGATED VESSELS. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN SUCCESSFULLY ADVANCED THE BENCHMARK OVER THE GUIDEWIRE TO THE TARGET VESSEL. AFTERWARDS, THE GUIDEWIRE WOULD NOT ROTATE SLIGHTLY AS EXPECTED. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE BENCHMARK AND GUIDEWIRE. WHILE REMOVING THE BENCHMARK, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY FRACTURED THE PROXIMAL END OF THE BENCHMARK OUTSIDE THE PATIENT. THE ENTIRE BENCHMARK WAS THEN PULLED OUT OF THE PATIENT BY HAND AND NO ADDITIONAL INTERVENTION WAS REQUIRED. THE PHYSICIAN WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16962397 ↗
• MalfunctionNov 17, 2022Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, AFTER A FEW MINUTES OF USE, THE PHYSICIAN NOTICED LEAKING FROM A HOLE AT THE PROXIMAL END OF THE BENCHMARK. THEREFORE; THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A NEW BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15820484 ↗
• InjuryApr 7, 2022Break; Unraveled Material; Physical Resistance/Sticking; Break; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A NEURON SELECT CATHETER 5F (5F SELECT). DURING THE PROCEDURE, WHILE ADVANCING THE BENCHMARK OVER THE 5F SELECT, THE PHYSICIAN EXPERIENCED RESISTANCE. WHILE RETRACTING THE BENCHMARK, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE BENCHMARK STRETCHED AND BROKE IN TWO PIECES. THEREFORE, THE PROXIMAL PIECE OF THE BENCHMARK WAS REMOVED. THE PATIENT WAS TAKEN TO SURGERY TO REMOVE THE REMAINING BROKEN BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14046240 ↗
• InjuryNov 8, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. UPON COMPLETION OF THE EMBOLIZATION PROCEDURE AND WHILE RETRACTING THE BENCHMARK, THE PHYSICIAN EXPERIENCED SOME RESISTANCE. SUBSEQUENTLY, THE BENCHMARK BROKE IN THE PATIENT. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND THE PIECE OF THE BENCHMARK WAS REMOVED SUCCESSFULLY. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771588 ↗
• MalfunctionMay 18, 2021Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A 6F NON-PENUMBRA SHORT INTRODUCER SHEATH. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE BENCHMARK INTO THE PATIENT USING THE 6F SHORTH INTRODUCER SHEATH, THEN ADVANCED THE BENCHMARK INTO THE CAROTID ARTERY. AFTERWARDS, THE PHYSICIAN INJECTED CONTRAST THROUGH THE BENCHMARK TO PERFORM AN ANGIOGRAPHY. SUBSEQUENTLY, IT WAS NOTICED THAT THE CONTRAST DID NOT COME OUT FROM THE DISTAL TIP OF THE BENCHMARK BUT PROXIMAL TO THE DISTAL TIP. IT WAS REPORTED THAT THE PHYSICIAN BELIEVED THAT THE BENCHMARK WAS FRACTURED. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK AND THE SAME SHORT INTRODUCER SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11842658 ↗
• MalfunctionApr 22, 2021Break; Fluid/Blood Leak; Material Deformation; Break; Fluid/Blood Leak; Material Deformation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE MANIPULATING THE BENCHMARK, THE DISTAL END FOLDED ON ITSELF BECOMING KINKED. IT WAS ALSO NOTED THAT BLOOD WAS LEAKING NEAR THE HUB OF THE CATHETER. THEREFORE, THE BENCHMARK WAS REMOVED. WHILE THE PHYSICIAN MANIPULATED A NEW BENCHMARK, THAT SAME ISSUE OCCURRED. IT WAS NOTED THAT BLOOD WAS LEAKING NEAR THE HUB OF THE CATHETER. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA GUIDING SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11710291 ↗
• MalfunctionApr 22, 2021Break; Fluid/Blood Leak; Material Deformation; Break; Fluid/Blood Leak; Material Deformation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE MANIPULATING THE BENCHMARK, THE DISTAL END FOLDED ON ITSELF BECOMING KINKED. IT WAS ALSO NOTED THAT BLOOD WAS LEAKING NEAR THE HUB OF THE CATHETER. THEREFORE, THE BENCHMARK WAS REMOVED. WHILE THE PHYSICIAN MANIPULATED A NEW BENCHMARK, THAT SAME ISSUE OCCURRED. IT WAS NOTED THAT BLOOD WAS LEAKING NEAR THE HUB OF THE CATHETER. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA GUIDING SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11710171 ↗
• MalfunctionJan 7, 2021Stretched; Stretched

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE TRAVERSE SINUS USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), NON-PENUMBRA SHEATH, AND NON-PENUMBRA STENT. DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY A STENT THROUGH THE BENCHMARK, THE PHYSICIAN STRETCHED THE DISTAL TIP OF THE BENCHMARK. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE SAME STENT AND SHEATH. THERE WAS NO REPORT OF ANY ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11136414 ↗
• MalfunctionJun 19, 2020Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE LEFT VERTEBRAL ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BENCHMARK INTO THE TARGET VESSEL, THEN INJECTED CONTRAST INTO THE BENCHMARK TO MAKE THE FIRST RUN; HOWEVER, IT WAS NOTICED THAT CONTRAST WAS LEAKING AT THE HUB OF THE BENCHMARK. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE IT. WHILE REMOVING THE BENCHMARK, IT BROKE AND STRETCHED OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10172357 ↗
• MalfunctionFeb 28, 2020Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE TO TREAT A BASILAR TIP ANEURYSM USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND NEURON SELECT CATHETER 5F SELECT (5F SLECT). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BENCHMARK AND 5F SELECT THROUGH THE AORTIC ARCH INTO THE POSTERIOR CIRCULATION. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE 5F SELECT ONCE IT REACHED THE VERTEBRAL ARTERY, HOWEVER IT WAS STUCK. AN ATTEMPT WAS MADE USING MORE FORCE TO RETRACT THE 5F SELECT BUT IT WAS UNSUCCESSFUL. THEREFORE, THE BENCHMARK CONTAINING THE 5F SELECT WAS REMOVED. UPON REMOVAL, IT WAS NOTICED THAT THE BENCHMARK WAS KINKED, AND 3-4 CENTIMETERS FROM THE DISTAL END WAS DEFORMED. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK AND A NEW 5F SELECT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9771252 ↗
• MalfunctionFeb 27, 2020Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE BASILAR ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, THE PHYSICIAN NOTICED AIR BUBBLES IN THE ROTATING HEMOSTASIS VALVE (RHV) OF THE BENCHMARK. LATER, BLOOD WAS FOUND LEAKING FROM JUST DISTAL TO THE HUB OF THE BENCHMARK; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9766184 ↗
• MalfunctionFeb 20, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE TO TREAT A BASILAR TIP ANEURYSM USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND NEURON SELECT CATHETER 5F SELECT (5F SLECT). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BENCHMARK AND 5F SELECT THROUGH THE AORTIC ARCH INTO THE POSTERIOR CIRCULATION. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE 5F SELECT ONCE IT REACHED THE VERTEBRAL ARTERY, HOWEVER IT WAS STUCK. AN ATTEMPT WAS MADE USING MORE FORCE TO RETRACT THE 5F SELECT BUT IT WAS UNSUCCESSFUL. THEREFORE, THE BENCHMARK CONTAINING THE 5F SELECT WAS REMOVED. UPON REMOVAL, IT WAS NOTICED THAT THE BENCHMARK WAS KINKED, AND 3-4 CENTIMETERS FROM THE DISTAL END WAS DEFORMED. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK AND A NEW 5F SELECT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9735435 ↗
• MalfunctionMay 3, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL TECHNICIAN NOTICED THAT A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) WAS KINKED AND PINCHED WITHIN ITS PACKAGING. THE DAMAGE TO THE BENCHMARK WAS FOUND PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK.

  Patient problems: No Patient Involvement

  MAUDE report 8579722 ↗
• MalfunctionMar 28, 2019Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, A BENCHMARK DELIVERY CATHETER (BENCHMARK) WAS BROKEN NEAR THE HUB UPON REMOVAL FROM ITS PACKAGING. THE DAMAGE TO THE BENCHMARK OCCURRED PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK.

  Patient problems: No Patient Involvement

  MAUDE report 8460686 ↗
• MalfunctionApr 20, 2018Break; Device Damaged Prior to Use; Out-Of-Box Failure; Break; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A MEDICAL PROCEDURE, TWO BENCHMARK 6F 071 DELIVERY CATHETERS (BENCHMARKS) BROKE UPON REMOVAL FROM THE PACKAGINGS. THE DAMAGE TO THE BENCHMARKS WERE FOUND PRIOR TO USE AND THEREFORE, THE BENCHMARKS WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK.

  Patient problems: No Patient Involvement

  MAUDE report 7448999 ↗
• MalfunctionApr 20, 2018Break; Device Damaged Prior to Use; Out-Of-Box Failure; Break; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A MEDICAL PROCEDURE, TWO BENCHMARK 6F 071 DELIVERY CATHETERS (BENCHMARKS) BROKE UPON REMOVAL FROM THE PACKAGINGS. THE DAMAGE TO THE BENCHMARKS WERE FOUND PRIOR TO USE AND THEREFORE, THE BENCHMARKS WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK.

  Patient problems: No Patient Involvement

  MAUDE report 7448995 ↗
• MalfunctionOct 18, 2017Fracture; Stretched; Out-Of-Box Failure; Fracture; Stretched; Out-Of-Box Failure

  DURING PREPARATION FOR A MEDICAL PROCEDURE, A HOSPITAL STAFF NOTICED THAT A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) WAS FRACTURED AND STRETCHED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE BENCHMARK WAS FOUND PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK.

  Patient problems: No Patient Involvement

  MAUDE report 6959164 ↗
• MalfunctionAug 7, 2017Kinked; Failure to Advance; Device Operates Differently Than Expected; Kinked; Failure to Advance; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE UPON INSERTION OF THE BENCHMARK INTO THE INTRODUCER SHEATH, AND SUBSEQUENTLY THE DISTAL TIP OF THE BENCHMARK BECAME SEVERELY KINKED; THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6772060 ↗
• MalfunctionAug 1, 2017Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGED BENCHMARK WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK.

  Patient problems: No Patient Involvement

  MAUDE report 6756956 ↗
• MalfunctionDec 15, 2016Out-Of-Box Failure; Tear, Rip or Hole in Device Packaging; Out-Of-Box Failure; Tear, Rip or Hole in Device Packaging

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE PACKAGING OF TWO BENCHMARK 6F 071 DELIVERY CATHETERS (BENCHMARK DC'S) WERE TORN AT THE TOP, WHICH BROKE THE STERILE BARRIER. THE TORN PACKAGING OF THE TWO BENCHMARK DC'S WERE FOUND PRIOR TO USE AND THEREFORE, THE BENCHMARK DC'S WERE NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX).

  Patient problems: No Patient Involvement

  MAUDE report 6178386 ↗
• MalfunctionDec 15, 2016Out-Of-Box Failure; Tear, Rip or Hole in Device Packaging; Out-Of-Box Failure; Tear, Rip or Hole in Device Packaging

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE PACKAGING OF TWO BENCHMARK 6F 071 DELIVERY CATHETERS (BENCHMARK DC'S) WERE TORN AT THE TOP, WHICH BROKE THE STERILE BARRIER. THE TORN PACKAGING OF THE TWO BENCHMARK DC'S WERE FOUND PRIOR TO USE AND THEREFORE, THE BENCHMARK DC'S WERE NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX).

  Patient problems: No Patient Involvement

  MAUDE report 6178320 ↗
• MalfunctionNov 16, 2016Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A MEDICAL PROCEDURE, A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK DC) SHAFT WAS KINKED UPON REMOVAL FROM ITS DISPENSER HOOP. THE KINKING OF THE BENCHMARK DC SHAFT OCCURRED PRIOR TO USE AND THEREFORE IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW BENCHMARK DC.

  Patient problems: No Patient Involvement

  MAUDE report 6105685 ↗
• MalfunctionApr 29, 2016Leak/Splash; Leak/Splash

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK KIT. DURING THE PROCEDURE, WHILE IN THE PATIENT AND AFTER A CONTRAST RUN WAS COMPLETED, A LEAK BETWEEN THE HUB AND THE PROXIMAL END OF THE BENCHMARK DELIVERY CATHETER (BENCHMARK DC) WAS NOTICED. THE BENCHMARK DC WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK DC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5620170 ↗
• MalfunctionApr 26, 2016Air Leak; Air Leak

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK DC). DURING THE PROCEDURE, THE PHYSICIAN PLACED A STENT AND THEN INSERTED THE BENCHMARK DC INTO THE PATIENT. WHILE THE DEVICE WAS INSIDE THE PATIENT, BUBBLES WERE OBSERVED IN THE HUB OF THE BENCHMARK DC. THERE WERE NO BUBBLES WHEN THE PHYSICIAN LET THE BENCHMARK DC BLEED BACK. HOWEVER, WHEN A SYRINGE WAS ATTACHED TO THE BENCHMARK DC AND PULLED BACK, BUBBLES APPEARED. THE BENCHMARK DC WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S DEVICE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5608260 ↗