Benchmark BMK6F95BER120Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 00814548014128), received between Sep 30, 2015 and Oct 1, 2024 — classified as 8 injuries, 76 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (31 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 84 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2024Leak/Splash; Leak/Splash

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NEURON SELECT CATHETER 5F (5F SELECT), A NON-PENUMBRA SHORT SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THE BENCHMARK IN THE ICA VIA FEMORAL ARTERY ACCESS USING THE SHORT SHEATH, 5F SELECT AND GUIDEWIRE. THE PHYSICIAN THEN NOTICED THAT THE PROXIMAL END OF THE BENCHMARK WAS LEAKING SALINE. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK AND THE SAME 5F SELECT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20345567 ↗
• MalfunctionJun 14, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON SELECT CATHETER 5F (5F SELECT), A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A FLOW DIVERTER, AND A GUIDEWIRE. IT WAS NOTED THAT THE PATENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE 5F SELECT USING THE BENCHMARK VIA RIGHT RADIAL ACCESS. THE 5F SELECT COULD NOT ADVANCE FURTHER UP THE RIGHT COMMON CAROTID ARTERY (CCA) DUE TO THE BENCHMARK NOT BEING ABLE TO ACHIEVE A STABLE POSITION. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE 5F SELECT AND BENCHMARK TO CONTINUE THE PROCEDURE VIA RIGHT FEMORAL ACCESS. UPON REMOVAL, IT WAS NOTICED THAT THE DISTAL LENGTH OF THE 5F SELECT WAS MISSING AND HAD FRACTURED IN THE RADIAL ARTERY. THE PHYSICIAN USED A STENT RETRIEVER TO SUCCESSFULLY REMOVE THE DISTAL FRAGMENT OF THE 5F SELECT. THE PROCEDURE WAS COMPLETED USING A NEW 5F SELECT AND A NEW BENCHMARK VIA RIGHT FEMORAL ACCESS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19542264 ↗
• MalfunctionJan 19, 2024Break; Leak/Splash; Break; Leak/Splash

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BENCHMARK TO THE TARGET LOCATION AND NOTICED THAT THE BENCHMARK WAS DAMAGED AT THE PROXIMAL END. IT WAS REPORTED THAT THE BENCHMARK WAS LEAKING AT THE HUB. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 18545238 ↗
• MalfunctionNov 3, 2023Fracture; Migration; Physical Resistance/Sticking; Fracture; Migration; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE TO PLACE A STENT IN THE TRANSVERSE SINUS USING A BENCHMARK DELIVERY 6F 071 CATHETER (BENCHMARK), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NON-PENUMBRA STENT, AND A NON-PENUMBRA SHEATH. IT WAS NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BENCHMARK TO THE TARGET LOCATION. WHILE ADVANCING THE STENT THROUGH THE SIGMOID AND TRANSVERSE SINUS, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN CONTINUED TO ADVANCE THE STENT AGAINST RESISTANCE AND SUBSEQUENTLY, FRACTURED THE BENCHMARK. IT WAS NOTED THAT THE FRACTURED PORTION OF THE BENCHMARK MIGRATED A LITTLE FURTHER WITHIN THE SAME VESSEL. THEREFORE, THE STENT WAS REMOVED, AND THE PROXIMAL BENCHMARK WAS REMOVED FROM THE SHEATH. A NEURON MAX AND A SNARE DEVICE WERE USED TO REMOVE THE DISTAL SEGMENT OF THE BENCHMARK. THE PROCEDURE WAS COMPLETED USING THE NEURON MAX AND THE SAME STENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070128 ↗
• MalfunctionMay 21, 2023Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A NEURON 5F SELECT CATHETER (5F SELECT). IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN GAINED RADIAL ACCESS WITH THE BENCHMARK. NEXT, WHILE ADVANCING THE 5F SELECT TO THE TARGET LOCATION, THE PHYSICIAN NOTICED THE DISTAL PART OF THE 5F SELECT WAS BROKEN ON THE ANGIOGRAM. THEN, THE PHYSICIAN GAINED FEMORAL ACCESS AND USED A SNARE DEVICE TO COMPLETELY REMOVE THE FRACTURED 5F SELECT. THE PROCEDURE WAS COMPLETED USING ANOTHER 5F SELECT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16971073 ↗
• MalfunctionMar 31, 2023Leak/Splash; Leak/Splash

  THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A NON-PENUMBRA CATHETER. AFTER SUCCESSFUL COMPLETION OF THE PROCEDURE, THE PHYSICIAN REMOVED THE BENCHMARK OUT FROM THE PATIENT AND NOTICED THE BENCHMARK WAS LEAKING AT THE PROXIMAL END. THE PROCEDURE HAD ENDED AT THIS POINT AND A COMPUTED TOMOGRAPHY (CT) PERFORMED TO CONFIRM THERE WAS NO AIR EMBOLUS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16659392 ↗
• MalfunctionMar 24, 2023Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOMM) 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, AFTER LOADING THE 5F SELECT INTO THE BENCHMARK AND OVER THE GUIDEWIRE, THE PHYSICIAN NOTICED A HOLE AT THE PROXIMAL END OF THE BENCHMARK WHILE ADVANCING THE BENCHMARK IN THE PATIENT. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK, THE SAME 5F SELECT, THE SAME SHEATH AND THE SAME GUIDEWIRE. THERE WAS NO REPORT OF AN EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16615152 ↗
• MalfunctionOct 27, 2022Break; Fracture; Leak/Splash; Break; Fracture; Leak/Splash

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, THE PHYSICIAN PLACED THE BENCHMARK IN THE TARGET LOCATION AND INITIATED ASPIRATION PRIOR TO PERFORMING AN ANGIOGRAM; HOWEVER, ONLY AIR WAS COMING BACK THROUGH THE BENCHMARK. SUBSEQUENTLY, THE HOSPITAL TECHNOLOGIST AND PHYSICIAN NOTICED THE BENCHMARK WAS FRACTURED AT THE HUB. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATHETER. THERE WAS NO REPORT OF AN EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15686567 ↗
• MalfunctionOct 14, 2022Break; Leak/Splash; Break; Leak/Splash

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A 6F NON-PENUMBRA SHORT SHEATH. DURING THE PROCEDURE, THE PHYSICIAN WAS IN THE PROCESS OF INSERTING THE BENCHMARK INTO A 6F SHORT SHEATH; HOWEVER, UPON ATTACHING THE BENCHMARK TO BE FLUSHED, THE PHYSICIAN NOTICED IT TO BE LEAKING PROXIMAL 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 15612032 ↗
• MalfunctionApr 26, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INFERIOR VENA CAVA (IVC) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BENCHMARK AND MICROCATHETER TO THE TARGET VESSEL AND TOOK MEASUREMENTS FROM A PREVIOUSLY PLACED STENT USING THE MICROCATHETER. SUBSEQUENTLY, WHILE RETRACTING THE BENCHMARK TO REMOVE IT, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED UNDER FLUOROSCOPY THAT THE BENCHMARK BECAME FRACTURED AT THE MID-SHAFT TO DISTAL END INSIDE THE PATIENT. THEREFORE, THE PHYSICIAN REMOVED THE BENCHMARK AND USED A SNARE DEVICE TO REMOVE THE BROKEN DISTAL PIECE OF THE BENCHMARK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14211799 ↗
• MalfunctionApr 14, 2022Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, THE PHYSICIAN FRACTURED THE BENCHMARK. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14115941 ↗
• MalfunctionJan 14, 2022Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NEURON SELECT CATHETER 5F (5F SELECT) AND A NON-PENUMBRA SHORT SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE 5F SELECT OVER A GUIDEWIRE THROUGH THE SHORT SHEATH AND BENCHMARK THROUGH THE COMMON ILIAC ARTERY (CIA) AND DESCENDING AORTA. THE GUIDEWIRE WAS THEN REMOVED AND THE 5F SELECT WAS FLUSHED. THE PHYSICIAN THEN ADVANCED THE BENCHMARK OVER THE 5F SELECT FOR MORE SUPPORT AND ONCE THE 5F SELECT ADVANCED OVER THE TRANSITION POINT, THE DISTAL END OF THE 5F SELECT BROKE OFF. THE PHYSICIAN THEN REMOVED THE BROKEN 5F SELECT USING A SNARE DEVICE FROM THE LEFT COMMON FEMORAL ARTERY. THE PROCEDURE WAS COMPLETED USING A NEW 5F SELECT AND A NEW BENCHMARK. IT SHOULD BE NOTED THAT THERE WAS NO ALLEGED DEVICE DEFICIENCY OR DAMAGE TO THE FIRST BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13260443 ↗
• InjuryNov 10, 2021Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A NON-PENUMBRA SHORT SHEATH, A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA MICROCATHETER AND PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THE SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER AND BENCHMARK. SUBSEQUENTLY, WHILE REMOVING THE BENCHMARK, A PIECE OF THE BENCHMARK BROKE OFF IN THE VESSEL. THEREFORE, THE PHYSICIAN DECIDED TO USE A SNARE DEVICE TO RETRIEVE THE BROKEN PIECE. WHILE REMOVING THE BROKEN PIECE OF THE BENCHMARK USING THE SNARE DEVICE, THE FEMORAL ARTERY BECAME DAMAGED. SUBSEQUENTLY, THE PATIENT UNDERWENT A VASCULAR REPAIR OF THE GROIN PUNCTURE SITE. THE PROCEDURE ENDED AFTER THE SUCCESSFUL VASCULAR REPAIR.

  Patient problems: Vascular Dissection

  MAUDE report 12785162 ↗
• InjuryNov 9, 2021Break; Break

  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 PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE POSITIONING THE BENCHMARK IN THE PATIENT, THE PHYSICIAN BROKE THE BENCHMARK AT THE MID-SHAFT. THE PHYSICIAN THEN USED A SNARE DEVICE TO SUCCESSFULLY REMOVE THE BROKEN BENCHMARK. THE PROCEDURE WAS COMPLETED USING ANOTHER BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12783705 ↗
• MalfunctionSep 29, 2021Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), NON-PENUMBRA CATHETER, A NON-PENUMBRA SHEATH, AND A T CONNECTOR. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE NON-PENUMBRA SHEATH IN THE ORIGIN OF THE LEFT INTERNAL CAROTID ARTERY. NEXT, THE PHYSICIAN ADVANCED THE BENCHMARK CONTAINING THE NON-PENUMBRA CATHETER IN THE CAROTID SIPHON, THE NON-PENUMBRA CATHETER WAS THEN REMOVED. SUBSEQUENTLY, WHEN THE PHYSICIAN CLOSED THE T CONNECTOR, BLOOD WAS NOTICED TO BE LEAKING BETWEEN THE HUB AND THE METAL REINFORCEMENT SEGMENT OF THE BENCHMARK. 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 12550282 ↗
• MalfunctionSep 13, 2021Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, UPON SUCCESSFUL DEPLOYMENT OF THE FLOW DIVERTER, THE PHYSICIAN ATTEMPTED TO DO A FINAL ANGIOGRAM THROUGH A BENCHMARK. WHEN THE PHYSICIAN FLUSHED CONTRAST, THEY NOTICED THE BENCHMARK WAS BROKEN AT THE HUB. THEREFORE, THE BENCHMARK WAS REMOVED. THE PHYSICIAN PERFORMED THE FINAL ANGIOGRAM THROUGH A SIM CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12465234 ↗
• InjurySep 1, 2021Break; Unraveled Material; Physical Resistance/Sticking; Break; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE VENOUS SINUS USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BENCHMARK TO THE TARGET VESSEL USING A GUIDEWIRE; HOWEVER, HE DECIDED TO REPLACE THE GUIDEWIRE WITH A LONGER GUIDEWIRE. WHILE ADVANCING THE GUIDEWIRE INTO THE BENCHMARK, THE PHYSICIAN FELT RESISTANCE AT THE DISTAL END OF THE BENCHMARK AND THEREFORE DECIDED TO RETRACT THE BENCHMARK OUT. WHILE RETRACTING, THE PHYSICIAN NOTICED SEVERAL BLACK DOTS ON THE IMAGES UNDER FLUOROSCOPY AND REALIZED THAT THE TIP OF THE BENCHMARK WAS BROKEN AND UNRAVELED. THE PHYSICIAN THEN USED A STENT RETRIEVER TO RETRIEVE THE TIP OF THE BENCHMARK SUCCESSFULLY. THE PHYSICIAN ABORTED THE PROCEDURE AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12411462 ↗
• MalfunctionJul 30, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE ARCH USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, WHILE ADVANCING THE BENCHMARK UP THE ARCH, THE DISTAL TIP OF THE BENCHMARK BECAME KINKED. THEREFORE, IT 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 12252375 ↗
• MalfunctionMay 28, 2021Unraveled Material; Unraveled Material

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), NEURON SELECT CATHETER 5F (5F SELECT), AND NON-PENUMBRA MICROCATHETERS. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE BENCHMARK AND 5F SELECT WERE ADVANCED INTO THE EXTERNAL CAROTID, THE PHYSICIAN THEN ADVANCED A MICROCATHETER INTO THE ARTERIOVENOUS FISTULA (AVF) AND INJECTED AN EMBOLIC AGENT. SUBSEQUENTLY, WHILE REMOVING THE BENCHMARK OVER THE GUIDEWIRE, THE PHYSICIAN NOTICED THE GUIDEWIRE BECAME STUCK INSIDE OF THE BENCHMARK AND THE BENCHMARK HAD STARTED TO UNRAVEL UPON REMOVAL. THE PROCEDURE HAD 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 11904684 ↗
• MalfunctionFeb 5, 2021Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAROTID ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND SHEATH. DURING THE PROCEDURE, WHILE INSERTING THE BENCHMARK INTO THE SHEATH, THE PHYSICIAN BROKE THE PROXIMAL END OF THE BENCHMARK. THEREFORE, IT 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 11285437 ↗
• MalfunctionJan 22, 2021Break; Unraveled Material; Failure to Advance; Break; Unraveled Material; Failure to Advance

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BENCHMARK INTO THE PATIENT AND SUBSEQUENTLY, THE BENCHMARK WOULD NOT ADVANCE THROUGH THE PATIENT¿S ANATOMY. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE BENCHMARK. UPON REMOVAL, IT WAS NOTICED THAT THE BENCHMARK WAS BROKEN AND UNRAVELED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA GUIDE 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 11217850 ↗
• InjuryDec 21, 2020Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE TO TREAT A BIFURCATION ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING A NEURON SELECT CATHETER 5F (5F SELECT), A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), AND A CONTOUR DEVICE. DURING THE PROCEDURE, WHILE DELIVERING THE 5F SELECT AND BENCHMARK TO THE TARGET LOCATION, THE DISTAL TIP OF THE 5F SELECT BROKE AND WAS DISLODGED. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO RETRIEVE THE TIP OF THE 5F SELECT. THE PROCEDURE WAS COMPLETED USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NON-PENUMBRA MICROCATHETER, AND THE SAME CONTOUR DEVICE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11049799 ↗
• MalfunctionNov 29, 2020Fracture; Material Deformation; Fracture; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, THE PROXIMAL END OF A BENCHMARK KINKED AND FRACTURED; THEREFORE, IT 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 10916650 ↗
• InjuryAug 7, 2020Break; Unraveled Material; Physical Resistance/Sticking; Break; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATION ARTERY (PCOM) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A NON-PENUMBRA 6F RADIAL SHEATH. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE BENCHMARK THROUGH THE SHEATH AND INTO THE PATIENT USING THE RIGHT RADIAL ACCESS. WHILE ADVANCING UP THE BENCHMARK TOWARDS THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE BENCHMARK. UPON REMOVAL OF THE BENCHMARK FROM THE SHEATH, THE PHYSICIAN NOTICED THAT THE TIP OF THE BENCHMARK HAD BROKEN OFF. IT WAS REPORTED THAT THE BRAIDING OF THE BENCHMARK UNRAVELED WITHIN THE AXILLARY AND RIGHT SUBCLAVIAN ARTERIES, AND THAT 10 CENTIMETERS OF THE TIP OF THE BENCHMARK WAS IN THE RADIAL ARTERY. SUBSEQUENTLY, AN ANGIOGRAM REVEALED PATENT SUBCLAVIAN, AXILLARY, BRACHIAL AND ULNAR ARTERIES, BUT A FULLY OCCLUDED RADIAL ARTERY. THE PHYSICIAN THEN MADE A SECOND PUNCTURE IN THE GROIN AND COMPLETED THE COILING. AFTERWARDS, THE BROKEN BENCHMARK TIP WAS REMOVED USING A SNARE DEVICE. THE FINAL FRAGMENT OF THE BENCHMARK WAS REMOVED VIA SURGERY IN THE RIGHT AXILLARY REGION. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADV

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10380178 ↗
• MalfunctionJul 23, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE M1 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE BENCHMARK THROUGH THE SHEATH, THE PHYSICIAN EXPERIENCE RESISTANCE AND REPORTED THAT THE BENCHMARK WOULD NOT FIT INTO THE SHEATH. CONSEQUENTLY, THE DISTAL TIP OF THE BENCHMARK BECAME OVALIZED AND KINKED. THEREFORE, THE BENCHMARK WAS REMOVED. THE PHYSICIAN DECIDED TO END THE PROCEDURE DUE TO UNFAVORABLE ANEURYSM LOCATION. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10317595 ↗