Benchmark BMK6F95MBER120Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00814548014173), received between Aug 21, 2015 and Feb 23, 2024 — classified as 2 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Break” (21 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 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2024Leak/Splash; Material Deformation; Physical Resistance/Sticking; Leak/Splash; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) 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, WHILE REMOVING THE 5F SELECT FROM THE BENCHMARK, THE PHYSICIAN EXPERIENCED RESISTANCE. AFTER REMOVING THE 5F SELECT WITH THE GUIDEWIRE, THE PHYSICIAN NOTICED BLOOD LEAKING NEAR THE HUB OF THE BENCHMARK. THEREFORE, THE BENCHMARK WAS REMOVED AND WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. IT WAS REPORTED THAT THE TECHNOLOGIST BELIEVED THAT THE BENCHMARK WAS KINKED WHILE REMOVING THE BENCHMARK FROM ITS PACKAGING AT THE SAME LOCATION WHERE THE BLOOD WAS LEAKING. IT WAS ALSO REPORTED THAT THE RESISTANCE WHILE REMOVING THE 5F SELECT WAS DUE TO THE KINK IN THE BENCHMARK. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK, A NEW 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 18769201 ↗
• MalfunctionJan 12, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BENCHMARK OVER THE GUIDEWIRE INTO THE PATIENT VIA FEMORAL ARTERY ACCESS. THE PHYSICIAN THEN FRACTURED THE PROXIMAL END OF THE BENCHMARK SHORTLY AFTER CATHETERIZING THE COMMON CAROTID ARTERY (CCA). IT WAS REPORTED THAT THERE WAS BLOOD LEAK AT THE FRACTURED LOCATION OF THE BENCHMARK. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18504775 ↗
• MalfunctionJan 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, AFTER PLACING THE BENCHMARK AT THE TARGET LOCATION, THE PHYSICIAN NOTICED THE BENCHMARK WAS LEAKING AT THE PROXIMAL END NEXT TO THE HUB. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK. THERE WAS NO REPORT OF AN EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16153038 ↗
• MalfunctionJan 3, 2023Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE TO TREAT A DISTAL ARTERIOVENOUS MALFORMATION (AVM) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), NON-PENUMBRA BALLOON CATHETER, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE BENCHMARK IN THE TARGET LOCATION AND DELIVERED THE BALLOON CATHETER USING THE MICROCATHETER AND FOUR VIALS OF EMBOLIC AGENT. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE BENCHMARK AND NOTICED A PERFORATION AT THE PROXIMAL END. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO MAINTAIN STABLE ACCESS THROUGHOUT THE PROCEDURE USING THE BENCHMARK. 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 16092205 ↗
• MalfunctionDec 22, 2022Fracture; Fracture

  THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND NON-PENUMBRA MICROCATHETERS. AFTER SUCCESSFUL COMPLETION OF THE PROCEDURE, THE PHYSICIAN REMOVED THE MICROCATHETER OUT FROM THE BENCHMARK AND NOTICED A HOLE AT THE PROXIMAL END OF THE BENCHMARK. IT WAS REPORTED THE PHYSICIAN ATTACHED A SYRINGE TO THE BENCHMARK TO PERFORM A CONTRAST INJECTION; HOWEVER, UPON PULLING BACK ON THE SYRINGE, THE PHYSICIAN NOTICED BUBBLES WERE BEING PULLED BACK INTO THE SYRINGE. THEREFORE, THE BENCHMARK WAS REMOVED. 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 16037980 ↗
• MalfunctionNov 4, 2022Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A NON-PENUMBRA SHORT SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE BENCHMARK THROUGH THE SHEATH IN THE GROIN, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE BENCHMARK BECAME STUCK. SUBSEQUENTLY, THE BENCHMARK WOULD NOT ADVANCE FURTHER IN THE SHEATH. THEREFORE, THE BENCHMARK WAS REMOVED. UPON REMOVAL, THE BENCHMARK WAS NOTICED TO BE FRACTURED AT TWO LOCATIONS APPROXIMATELY EIGHT INCHES AND ELEVEN INCHES FROM THE DISTAL END. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15729548 ↗
• MalfunctionJul 26, 2022Fracture; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING THE BENCHMARK INTO THE TARGET LOCATION, THE PHYSICIAN FRACTURED THE PROXIMAL END OF THE BENCHMARK TOWARDS THE HUB. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108658 ↗
• MalfunctionMar 4, 2022Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BASILAR ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE BENCHMARK IN THE V3 SEGMENT OF THE LEFT VERTEBRAL ARTERY USING RADIAL ACCESS. WHILE THE PHYSICIAN ATTEMPTED TO ADVANCE THE CATHETER THROUGH THE BENCHMARK, THE PHYSICIAN EXPERIENCED RESISTANCE; AND THE CATHETER WOULD NOT ADVANCE THROUGH. THEREFORE, THE PHYSICIAN REMOVED THE CATHETER. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO ADVANCE THREE OTHER CATHETERS THROUGH THE BENCHMARK; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE THREE CATHETERS WERE ALSO REMOVED. AFTERWARDS, WHILE ADVANCING A 3MAXC THROUGH THE BENCHMARK, THE PHYSICIAN EXPERIENCED RESISTANCE. HOWEVER, THE PHYSICIAN WAS ABLE TO ADVANCE THE 3MAXC THROUGH THE BENCHMARK AND COMPLETED THE PROCEDURE WITH ONE PASS USING THE 3MAXC AND BENCHMARK. UPON REMOVAL OF THE BENCHMARK AND THE 3MAXC, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE BENCHMARK WAS BROKEN. 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 13674452 ↗
• MalfunctionFeb 7, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE RIGHT TRANSVERSE SINUS USING A BENCHMARK DELIVERY CATHETER (BENCHMARK), A SELECT CATHETER, A GUIDEWIRE, A NEURON SELECT CATHETER 5F (5F SELECT), A NON-PENUMBRA SHEATH, AND A STENT SYSTEM. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BENCHMARK THROUGH THE SHEATH AND OVER THE 5F SELECT TO THE TARGET VESSEL. NEXT, THE PHYSICIAN EXPERIENCED SLIGHT RESISTANCE WHILE ADVANCING THE GUIDEWIRE AND THE STENT SYSTEM THROUGH THE BENCHMARK FROM THE SIGMOID TO THE TRANSVERSE SINUS BUT WAS ABLE TO REACH THE TARGET VESSEL. AFTER ADVANCING THE STENT SYSTEM IN THE TARGET VESSEL, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE BENCHMARK HAD FRACTURED. THE PHYSICIAN THEN RETRACTED THE ENTIRE SYSTEM DOWN IN THE INFERIOR VENA CAVA (IVC) WITH THE STENT SYSTEM IN THE DISTAL END OF THE BENCHMARK. AFTER THAT, THE PHYSICIAN USED A GOOSE NECK SNARE DEVICE (25MM) THROUGH THE LEFT FEMORAL VEIN TO REMOVE THE BROKEN PART OF THE BENCHMARK THROUGH THE LEFT GROIN. IT WAS REPORTED THAT THE PROXIMAL END OF THE BENCHMARK AND STENT SYSTEM WERE REMOVED FROM THE RIGHT GROIN. SUBSEQUENTLY, WHILE ADVANCING A NE

  Patient problems: Insufficient Information

  MAUDE report 13472751 ↗
• MalfunctionFeb 1, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING A BENCHMARK DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA CATHETER AND A NON-PENUMBRA SHEATH. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE ADVANCING THE NON-PENUMBRA CATHETER INTO THE BENCHMARK. THEREFORE, THE PHYSICIAN DECIDED TO WITHDRAW THE CATHETER; HOWEVER, THE CATHETER BECAME STUCK INSIDE THE BENCHMARK. WHEN THE PHYSICIAN PULLED ON THE NON-PENUMBRA CATHETER, THE BENCHMARK BROKE AT THE DISTAL END. SUBSEQUENTLY, THE DISTAL PART OF THE BENCHMARK MIGRATED TO THE ILIAC ARTERY. THE BENCHMARK AND THE NON-PENUMBRA CATHETER WERE REMOVED FROM THE PATIENT. THEN, THROUGH A SECOND ACCESS POINT AT THE OPPOSITE SIDE IN THE GROIN, A SNARE DEVICE AND A BALLOON WERE INTRODUCED, AND THE BROKEN PART OF THE BENCHMARK WAS SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK, A NEW CATHETER, AND A NEW SHEATH THROUGH THE SECOND ACCESS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13419573 ↗
• InjuryJan 14, 2022Break; Activation, Positioning or Separation Problem; Material Twisted/Bent

  PENUMBRA BENCHMARK DELIVERY CATHETER 5F ADVANCED AND STENT WOULD NOT DEPLOY, REMOVED AND CASING ACCORDION SHAPE AND UNABLE TO THREAD. NEXT CATHETER ADVANCED AND PIECE BROKE OFF. ABLE TO RETRIEVE. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 13282472 ↗
• MalfunctionMay 18, 2021Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCCA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, ONCE THE BENCHMARK WAS HOOKED UP TO FLUSH LINE, THE BENCHMARK WAS NOTICED TO BE BROKEN AT THE HUB. THEREFORE, THE BENCHMARK WAS REMOVED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11841718 ↗
• MalfunctionApr 8, 2021Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOMM) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, AFTER ADVANCING THE BENCHMARK INTO THE PATIENT, THE PHYSICIAN NOTICED AIR IN THE TUBING OF THE BENCHMARK. SUBSEQUENTLY, THE BENCHMARK WAS PULLED OUT OF THE PATIENT TO BE FLUSHED; HOWEVER, WHILE FLUSHING ON THE BACK TABLE, THE HOSPITAL NOTICED THE BENCHMARK TO BE LEAKING BY THE HUB. THEREFORE, THE BENCHMARK WAS NOT USED IN THE PROCEDURE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11638177 ↗
• MalfunctionJan 8, 2021Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, WHILE ADVANCING THE BENCHMARK INTO THE PATIENT, THE PHYSICIAN FRACTURED THE HUB OF THE BENCHMARK. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 11143068 ↗
• MalfunctionJan 7, 2021Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE BENCHMARK INTO THE SHEATH, THE PHYSICIAN FRACTURED THE BENCHMARK AT THE HUB. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 11136363 ↗
• MalfunctionDec 16, 2020Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, THE BENCHMARK WAS FOUND BROKEN AT THE HUB. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 11015915 ↗
• MalfunctionDec 4, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), NON-PENUMBRA 6FR SHORT SHEATH, AND NON-PENUMBRA MICROCATHETER. APPROXIMATELY HALFWAY THROUGH THE PROCEDURE, THE PHYSICIAN NOTICED A LEAK NEAR THE HUB OF THE BENCHMARK. THEREFORE, THE PHYSICIAN INCREASED FLUSH AND COMPLETED THE PROCEDURE USING THE SAME BENCHMARK, SHEATH AND MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 10943312 ↗
• MalfunctionAug 7, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA MICROCATHETER, AND GUIDEWIRES. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THE HUB OF THE BENCHMARK WAS CRACKED UPON INTRODUCTION TO THE TARGET VESSEL. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE SAME MICROCATHETER, AND NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10382593 ↗
• MalfunctionJul 23, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA SHORT SHEATH, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE BENCHMARK BECAME KINKED NEAR THE DISTAL TIP WHILE INTRODUCING IT TO THE SHEATH. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER BENCHMARK, THE SAME MICROCATHETER, 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 10312887 ↗
• MalfunctionJul 2, 2020Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A NON-PENUMBRA 7F SHEATH. DURING THE PROCEDURE, AFTER ADVANCING THE BENCHMARK INTO THE PATIENT USING THE 7F SHEATH, THE PHYSICIAN NOTICED BLEEDING AT THE PUNCTURE SITE. UPON CHECKING, IT WAS NOTICED THAT THE BENCHMARK WAS BROKEN AT THE HUB; THEREFORE, IT WAS REMOVED. 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 10222924 ↗
• InjuryJun 18, 2020Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, THE PHYSICIAN USED THE BENCHMARK, A BALLOON CATHETER AND TWO MICROCATHETERS TO IMPLANT THE COILS IN THE TARGET VESSEL. WHILE PERFORMING THE FINAL ANGIOGRAPHY THROUGH THE BENCHMARK AT THE END OF THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE BENCHMARK WAS BROKEN AT THE MID-SHAFT. IT WAS REPORTED THAT AFTER SEVERAL ATTEMPTS, THE PHYSICIAN WAS ABLE TO REMOVE THE BROKEN PIECE OF THE BENCHMARK USING A BIGGER FEMORAL SHEATH AND A SNARE DEVICE. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10170212 ↗
• MalfunctionMar 26, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT RADIAL ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A NEURON SELECT CATHETER 5F (5F SELECT) FROM A BENCHMARK KIT. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE 5F SELECT INTO THE BENCHMARK. UPON REMOVAL OF THE 5F SELECT, THE PHYSICIAN FOUND A WIRE FROM THE BENCHMARK ATTACHED. SUBSEQUENTLY, THE PHYSICIAN REALIZED THE BENCHMARK WAS UNRAVELING. IT WAS ALSO REPORTED THAT PURPLE COATING WAS COMING OFF OF THE 5F SELECT. THEREFORE, THE BENCHMARK AND 5F SELECT WERE NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK AND A NEW 5F SELECT FROM A NEW BENCHMARK KIT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9886627 ↗
• MalfunctionMar 26, 2020Unraveled Material; Unraveled Material

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT RADIAL ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A NEURON SELECT CATHETER 5F (5F SELECT) FROM A BENCHMARK KIT. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE 5F SELECT INTO THE BENCHMARK. UPON REMOVAL OF THE 5F SELECT, THE PHYSICIAN FOUND A WIRE FROM THE BENCHMARK ATTACHED. SUBSEQUENTLY, THE PHYSICIAN REALIZED THE BENCHMARK WAS UNRAVELING. IT WAS ALSO REPORTED THAT PURPLE COATING WAS COMING OFF OF THE 5F SELECT. THEREFORE, THE BENCHMARK AND 5F SELECT WERE NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK AND A NEW 5F SELECT FROM A NEW BENCHMARK KIT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9886624 ↗
• MalfunctionMar 6, 2020Break; Material Deformation; Break; Material Deformation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE PLACING THE BENCHMARK IN THE PATIENT, THE PHYSICIAN NOTICED THE PROXIMAL SECTION NEAR THE HUB OF THE BENCHMARK BECAME OVALIZED AND BROKEN. THEREFORE, THE BENCHMARK WAS REMOVED. 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 9802308 ↗
• MalfunctionFeb 3, 2020Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, IT WAS REPORTED THAT THE BENCHMARK BECAME FRACTURED NEAR THE HUB. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9662614 ↗