Benchmark BMK6F105BER130Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00814548014029), received between Nov 19, 2015 and Dec 22, 2023 — classified as 4 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2023Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NEURON SELECT CATHETER 5F (5F SELECT), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BENCHMARK INTO THE INTERNAL CAROTID ARTERY (ICA) USING THE 5F SELECT AND THE GUIDEWIRE. UPON REMOVAL OF THE 5F SELECT AND GUIDEWIRE, THE PHYSICIAN ATTACHED A CONTRAST LINE TO THE HUB OF THE BENCHMARK AND NOTICED A LEAK. THE PHYSICIAN THEN REALIZED THAT THE BENCHMARK WAS FRACTURED AT THE PROXIMAL LENGTH, NEAR THE HUB. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK, THE SAME 5F SELECT, AND THE SAME GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18381840 ↗
• MalfunctionJul 21, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BENCHMARK OVER THE GUIDEWIRE TO THE SUBCLAVIAN ARTERY. THE PHYSICIAN THEN REMOVED THE GUIDEWIRE TO FLUSH THE BENCHMARK AND SUBSEQUENTLY NOTICED THAT THE PROXIMAL END OF THE BENCHMARK WAS FRACTURED. 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 17375034 ↗
• MalfunctionJun 29, 2022Unraveled Material; Unraveled Material

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA MICROCATHETER AND A NON-PENUMBRA SHEATH. AFTER COMPLETION OF THE PROCEDURE, WHILE RETRACTING THE BENCHMARK, THE BENCHMARK STARTED TO UNRAVEL. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE BENCHMARK BY PULLING IT OUT. THE PROCEDURE WAS COMPLETED AT THIS POINT. IT WAS REPORTED THAT UPON INSPECTION OF THE BENCHMARK NEXT DAY, THE PROXIMAL END OF THE BENCHMARK WAS NOTICED TO BE SEPARATED WITH THE COIL WIND ATTACHED TO THE REST OF THE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14860816 ↗
• MalfunctionMar 16, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, IT WAS REPORTED WHILE REMOVING THE BENCHMARK, THE PHYSICIAN EXPERIENCED RESISTANCE BUT THE PHYSICIAN CONTINUED REMOVING THE BENCHMARK AGAINST RESISTANCE. CONSEQUENTLY, THE PHYSICIAN HAD FRACTURED AND BROKE THE BENCHMARK IN THE RADIAL ARTERY. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE BROKEN BENCHMARK. 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 13778374 ↗
• InjuryNov 24, 2021Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A DIAGNOSTIC CATHETER IN THE RIGHT SUBCLAVIAN ARTERY. DURING THE PROCEDURE, THE DIAGNOSTIC CATHETER AND THE BENCHMARK WERE ADVANCED TOGETHER IN THE TARGET LOCATION WITH THE DIAGNOSTIC CATHETER INSIDE THE BENCHMARK. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE ADVANCING THE CATHETERS IN THE MID-UPPER ARM. THEN, THE DIAGNOSTIC CATHETER WAS REMOVED, AND SELECTIVE ANGIOGRAPHY WAS PERFORMED USING THE BENCHMARK. THE ANGIOGRAPHY REVEALED INADVERTENT SELECTION OF A SMALL ARTERY ARISING FROM THE BRANCH OF A RIGHT BRACHIAL ARTERY. VERAPAMIL WAS THEN USED TO AID REMOVAL OF THE BENCHMARK AND TO ALLEVIATE ANY VASOSPASM. AFTER ADMINISTRATION OF VERAPAMIL, THE PHYSICIAN ATTEMPTED TO WITHDRAW THE BENCHMARK; HOWEVER, THE DISTAL END OF THE BENCHMARK BROKE LEAVING THE RETAINED FRAGMENT IN THE RIGHT ARM. THE BENCHMARK APPEARED TO BE FRACTURED AND UNRAVELED, LEAVING A SMALL INNER COIL FRAGMENT FROM THE CATHETER TETHERED FROM THE UPPER ARM TO THE ARTERIAL ACCESS SITE AT THE RIGHT WRIST. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12872326 ↗
• MalfunctionNov 12, 2021Entrapment of Device; Fracture; Unraveled Material; Difficult to Advance

  A 5-FRENCH BERNSTEIN DIAGNOSTIC CATHETER WITHIN A 6-FRENCH BENCHMARK GUIDE CATHETER WAS ADVANCED FREELY UP THE RIGHT ARM INTO THE RIGHT SUBCLAVIAN ARTERY UNDER NATIVE FLUOROSCOPIC GUIDANCE. WHEN ADVANCING THE DIAGNOSTIC AND GUIDE CATHETERS, THERE WAS RESISTANCE ENCOUNTERED IN THE MID-UPPER ARM. THE DIAGNOSTIC CATHETER WAS REMOVED AND SELECTIVE ANGIOGRAPHY THROUGH THE GUIDE CATHETER WAS PERFORMED DEMONSTRATING INADVERTENT SELECTION OF A SMALL ARTERY ARISING FROM THE RIGHT BRACHIAL ARTERY. 2MG OF INTRA-ARTERIAL VERAPAMIL WAS INFUSED THROUGH THE GUIDE CATHETER TO HELP FACILITATE REMOVAL OF THE CATHETER AND ALLEVIATE ANY VASOSPASM. AFTER ADMINISTRATION OF VERAPAMIL, AN ATTEMPT WAS MADE TO WITHDRAW THE GUIDE CATHETER; HOWEVER, THE GUIDE CATHETER BROKE LEAVING A RETAINED FRAGMENT IN THE RIGHT ARM. IT APPEARED AS IF THE CATHETER HAD FRACTURED AND THEN UNRAVELED, LEAVING A SMALL INNER COIL FRAGMENT FROM THE CATHETER ITSELF TETHERED FROM THE UPPER ARM TO THE ARTERIAL ACCESS SITE AT THE RIGHT WRIST. MANUFACTURER RESPONSE FOR CATHETER, PERCUTANEOUS, BENCHMARK (PER SITE REPORTER): THEY WILL INVESTIGATE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12804983 ↗
• MalfunctionJul 8, 2021Fracture; Fracture

  THE PATIENT UNDERWENT A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND NON-PENUMBRA SHEATH. AFTER SUCCESSFUL COMPLETION OF THE PROCEDURE, WHILE REMOVING THE BENCHMARK FROM THE RADIAL ARTERY, THE PHYSICIAN NOTICED THE MIDSHAFT OF THE BENCHMARK HAD FRACTURED. SUBSEQUENTLY, THE PHYSICIAN RETRACTED THE FRACTURED PORTION OF THE BENCHMARK BACK INTO THE SHEATH AND REMOVED BOTH THE BENCHMARK AND SHEATH TOGETHER AS A SYSTEM. IT WAS ALSO REPORTED THAT THE PATIENT WAS ADMINISTERED WITH RADIAL COCKTAIL; HOWEVER, A VASOSPASM HAD OCCURRED WHILE REMOVING THE BENCHMARK. THE PROCEDURE HAD ENDED AT THIS POINT AND NO MEDICAL INTERVENTION WAS PERFORMED TO TREAT THE VASOSPASM. IT WAS REPORTED THAT THE VASOSPASM WAS RELATED TO USE OF THE BENCHMARK.

  Patient problems: Vasoconstriction

  MAUDE report 12139750 ↗
• MalfunctionApr 27, 2021Fracture; Leak/Splash; Fracture; Leak/Splash

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE BASILAR ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY COMPLETED THE FIRST PASS USING THE BENCHMARK. THEN, AFTER ADVANCING THE BENCHMARK TO THE TARGET VESSEL DURING THE SECOND PASS, THE HOSPITAL TECHNOLOGIST NOTICED THAT THE BENCHMARK WAS LEAKING NEAR 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

  MAUDE report 11734488 ↗
• MalfunctionApr 14, 2021Break; Break

  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, THE HOSPITAL FELLOW FLEXED THE BENCHMARK AT THE PROXIMAL END/ HUB WHILE ADVANCING IT THROUGH THE SHEATH. CONSEQUENTLY, THE BENCHMARK BROKE JUST AFTER THE HUB. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED BY 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 11662650 ↗
• MalfunctionFeb 22, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND 6FR NON-PENUMBRA SHEATH. IT WAS REPORTED THAT THE BENCHMARK WAS FLUSHED PRIOR TO USE IN THE PROCEDURE. DURING THE PROCEDURE, AFTER ADVANCING THE BENCHMARK INTO THE PATIENT, THE PHYSICIAN NOTICED THE BENCHMARK TO BE LEAKING NEAR THE HUB. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 11362801 ↗
• MalfunctionAug 20, 2020Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ADVANCING A BENCHMARK OVER A WIRE AND INTO THE SHEATH, THE MID-SHAFT OF THE BENCHMARK FRACTURED. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER BENCHMARK AND THE SAME SHEATH AND WIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10435343 ↗
• MalfunctionJul 3, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE BENCHMARK OVER THE GUIDEWIRE WITH NO DELIVERY CATHETER IN THE CAROTID ARTERY, THE BENCHMARK KINKED; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE REMOVING THE BENCHMARK. 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 10228388 ↗
• InjuryMar 18, 2020Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), NON-PENUMBRA MICROCATHETER AND, NON-PENUMBRA SHEATH. DURING THE PROCEDURE, AFTER COMPLETION OF COILING AN ANEURYSM, THE PHYSICIAN REMOVED THE MICROCATHETER AND BEGAN TO RETRACT THE BENCHMARK TO REMOVE IT. HOWEVER, WHILE RETRACTING, THE DISTAL END OF THE BENCHMARK HAD BROKEN OFF. THE PHYSICIAN THEN USED A SNARE DEVICE TO CAPTURE THE BROKEN PIECE OF THE BENCHMARK AND RETRACT IT DOWN TO THE SHEATH, HOWEVER, THE PHYSICIAN WAS UNABLE TO RETRACT THE SNARE DEVICE BACK INTO THE SHEATH. THEREFORE, THE PHYSICIAN PERFORMED A FEMORAL ARTERY CUTDOWN SURGERY TO REMOVE THE BROKEN PIECE OF THE BENCHMARK. IT WAS NOTED THAT A RETROPERITONEAL BLEED OCCURRED AND, SUBSEQUENTLY, WAS RESOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9849757 ↗
• MalfunctionMar 6, 2020Retraction Problem; Material Deformation; Physical Resistance/Sticking; Retraction Problem; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE CAROTID ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), NON-PENUMBRA BALLOON CATHETER AND SPIDER WIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BENCHMARK AS A GUIDE CATHETER AND PLACED THE BALLOON CATHETER AND SPIDER WIRE IN THE TARGET VESSEL. AFTER INFLATING THE BALLOON TO NORMAL PRESSURE AND DEFLATING, THE PHYSICIAN ATTEMPTED TO RETRACT THE BALLOON CATHETER BACK INTO THE BENCHMARK; HOWEVER, EXPERIENCED RESISTANCE AND WAS UNABLE TO FULLY RETRACT THE BALLOON CATHETER BACK INTO THE BENCHMARK. THEREFORE, THE PHYSICIAN REMOVED SYSTEM AND FOUND THE DISTAL TIP OF THE BENCHMARK TO BE ¿ACCORDIONED¿. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA GUIDE CATHETER, GUIDEWIRE AND STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9801016 ↗
• MalfunctionFeb 6, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND RADIAL SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE BENCHMARK UNSUPPORTED THROUGH THE SHEATH IN THE TARGET VESSEL, THE PROXIMAL END OF THE BENCHMARK BENT AND BROKE; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA DEVICES. THERE WAS NO ADVERSE EFFECT TO THE PATIENT. THE EXACT EVENT DATE IS UNKNOWN, AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9679670 ↗
• MalfunctionFeb 6, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND RADIAL SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE BENCHMARK UNSUPPORTED THROUGH THE SHEATH IN THE TARGET VESSEL, THE PROXIMAL END OF THE BENCHMARK BENT AND BROKE; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA DEVICES THERE WAS NO ADVERSE EFFECT TO THE PATIENT. THE EXACT EVENT DATE IS UNKNOWN, AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9679651 ↗
• MalfunctionAug 2, 2019Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), AND PENUMBRA SMART COILS (SMART COILS). IT SHOULD BE NOTED THAT THERE WAS A TORTUOUS TONSILLAR LOOP IN THE COMMON CAROTID ARTERY (CCA). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE NEURON MAX INTO THE PATIENT¿S ANATOMY BUT FELT THAT IT WOULD NOT PROVIDE ENOUGH SUPPORT TO GUIDE THE PX SLIM OVER THE TONSILLAR LOOP. THEREFORE, THE NEURON MAX WAS REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PHYSICIAN THEN DECIDED TO USE A BENCHMARK AS THE GUIDE. HOWEVER, WHILE ADVANCING THE BENCHMARK HALFWAY THROUGH THE TONSILLAR LOOP, IT WAS REPORTED THAT THE BENCHMARK FELT STIFF. THE PHYSICIAN DECIDED NOT TO ADVANCE THE BENCHMARK ANY FURTHER INTO THE PATIENT¿S ANATOMY AND IT WAS THEREFORE REMOVED FROM THE PROCEDURE. A NON-PENUMBRA SHEATH WAS THEN ADVANCED, FOLLOWED BY THE SAME PX SLIM; HOWEVER, THE PX SLIM WAS NOT COMPATIBLE WITH THE TECHNIQUE THE PHYSICIAN PREFERRED TO USE AND WAS THEREFORE REMOVED FROM THE PROCEDURE. THERE WAS NO OTHER ISSUE NOTED WIT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8858102 ↗
• MalfunctionOct 9, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) WAS BROKEN CLOSE TO THE HUB. THE BROKEN BENCHMARK WAS FOUND PRIOR TO USE AND, THEREFORE, THE BENCHMARK WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK.

  Patient problems: No Patient Involvement

  MAUDE report 7949631 ↗
• MalfunctionMay 30, 2018Component Missing; Component Missing

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE PEEL-AWAY INTRODUCER SHEATH OF THE BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) WAS MISSING. THE REPORTED ISSUE WAS FOUND PRIOR TO USE. THEREFORE, THE BENCHMARK WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK.

  Patient problems: No Patient Involvement

  MAUDE report 7555225 ↗
• MalfunctionMar 1, 2018Partial Blockage; Physical Resistance; Partial Blockage; Physical Resistance

  THE PATIENT WAS UNDERGOING MEDICAL PROCEDURE IN THE MESENTERIC ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, THE PHYSICIAN PLACED A STENT DEVICE IN THE TARGET VESSEL USING THE BENCHMARK. WHILE ATTEMPTING TO ADVANCE A SECOND STENT DEVICE THROUGH THE BENCHMARK, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE STENT DEVICE BECAME STUCK INSIDE THE BENCHMARK. THEREFORE, THE PHYSICIAN REMOVED THE BENCHMARK AND THE STENT DEVICE ALTOGETHER AND DECIDED TO END THE PROCEDURE AT THAT POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7307165 ↗
• MalfunctionFeb 27, 2018Unraveled Material; Device Damaged Prior to Use; Unraveled Material; Device Damaged Prior to Use

  WHILE PREPARING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) FOR A MEDICAL PROCEDURE, IT WAS NOTICED THAT THE ROUND WIRE BRAIDING UNWOUND INTO THE HUB OF THE BENCHMARK. 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 7299945 ↗
• MalfunctionJan 11, 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, IT WAS NOTICED THAT THE BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) WAS SEPARATED WHEN COMING OUT OF 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 7183278 ↗
• MalfunctionDec 7, 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 PHYSICIAN OPENED A NEW BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND WHEN PREPARING TO FLUSH IT, NOTICED THAT THE BENCHMARK WAS KINKED AT THE PROXIMAL END JUST DISTAL TO THE HUB. THE KINKED BENCHMARK WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER BENCHMARK.

  Patient problems: No Patient Involvement

  MAUDE report 7096050 ↗
• MalfunctionSep 29, 2017Retraction Problem; Physical Resistance; Material Deformation; Retraction Problem; Physical Resistance; Material Deformation

  THE PATIENT WAS UNDERGOING A CAROTID STENTING PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED A DISTAL PROTECTION DEVICE THROUGH THE BENCHMARK. THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO RETRACT THE DISTAL PROTECTION DEVICE INTO THE BENCHMARK; THEREFORE THE BENCHMARK AND DISTAL PROTECTION DEVICE WERE REMOVED TOGETHER AND THE PROCEDURE WAS ENDED. UPON REMOVAL, IT WAS FOUND THAT THE TIP OF THE BENCHMARK WAS SCRUNCHED AND THE LUMEN WAS COMPROMISED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6904413 ↗
• MalfunctionOct 26, 2016Material Separation; Device Damaged Prior to Use; Material Separation; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE PHYSICIAN NOTICED THAT THE TIP OF THE BENCHMARK SELECT CATHETER (SELECT) THAT IS SHIPPED IN A KIT WITH THE BENCHMARK DELIVERY CATHETER (BENCHMARK DC) CAME OFF AFTER WIPING DOWN THE OUTSIDE OF THE SELECT. THE TIP OF THE SELECT CAME OFF PRIOR TO USE AND THEREFORE THE SELECT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 6057605 ↗