MarksmanTM FA-55160-1030 (UDI 00847536026278)Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00847536026278), received between Oct 4, 2018 and Mar 30, 2026 — classified as 3 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Break” (18 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Retraction Problem

  ADDITIONAL INFORMATION WAS RECEIVED. THE PIPELINE FAILED TO OPEN AT THE PROXIMAL END OF THE STENT AND WAS NOT PLACED IN A VESSEL BEND AT THE TIME OF THE FAILURE TO OPEN. NO ADDITIONAL STEPS OR OTHER DEVICES WERE SUCCESSFULLY USED TO OPEN THE PIPELINE, AS THE STENT COULD NOT BE RETRIEVED INTO THE CATHETER DESPITE AN ATTEMPT BEING MADE. THE CATHETER DID NOT ENCOUNTER RESISTANCE DURING RETRIEVAL OF THE STENT. THE CAUSE OF THE EVENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24734397 ↗
• MalfunctionNov 6, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT IN PREPARATION FOR DELIVERY OF THE PIPELINE FLEX STENT (PED), THE MARKSMAN STENT CATHETER WAS ADVANCED OVER THE GUIDEWIRE TO SEGMENT M1 AND THE GUIDEWIRE WAS WITHDRAWN. THE STENT PACKAGING WAS OPENED, AND HIGH-PRESSURE HYDRATION WAS PERFORMED UNTIL 10 DROPS OF FLUID WERE RELEASED. THE DELIVERY SHEATH WAS THEN PRESSED AGAINST THE MARKSMAN PORT, AND THE STENT WAS DELIVERED TO SEGMENT M1. AFTER THE STENT CATHETER TIP CAME OUT, THE STENT OPENED SMOOTHLY AT THE TIP FOR ABOUT 3 MM. DEPLOYMENT WAS CONTINUED, BUT WHEN THE STENT WAS DEPLOYED TO THE MID-TO-DISTAL SEGMENT, IT WAS FOUND THAT THE MIDDLE OF THE STENT COULD NOT BE OPENED. THE Y-VALVE WAS LOCKED, AND MULTIPLE PUSH-PULL MANEUVERS WERE ATTEMPTED, BUT THE STENT STILL COULD NOT BE OPENED. AFTER UNLOCKING THE Y-VALVE AND RETRACTING THE STENT FOR RE-DEPLOYMENT, THE STENT STILL COULD NOT BE OPENED. ADDITIONAL PUSH-PULL ATTEMPTS WERE MADE, BUT THE STENT REMAINED UNOPENED. AN ATTEMPT WAS MADE TO RETRIEVE THE STENT INTO THE MARKSMAN CATHETER, BUT THE STENT COULD ONLY BE WITHDRAWN TO ABOUT 2 MM FROM THE STENT TIP AND COULD NOT BE FULLY RETRIEVED INTO THE STENT CATHETER. DURING WITHDRAWAL OF BOTH THE STENT AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490078 ↗
• MalfunctionSep 5, 2025Retraction Problem; Unintended Movement; Physical Resistance/Sticking; Retraction Problem; Unintended Movement; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PED DID NOT JUMP DURING DEPLOYMENT. THE PROBLEM OCCURRED WHEN TRYING TO RETRIEVE OR RESHEATH THE DEVICE INSIDE THE MICROCATHETER. ONLY ONE DEVICE WAS USED FOR THE EMBOLIZATION. HOWEVER, THERE WERE SEVERAL VENDORS, AND WHEN THE MEDTRONIC DEVICE FAILED, THE DOCTOR DECIDED TO USE A NON-MEDTRONIC DEVICE. THE TENSION WAS GENERATED WHEN TRYING TO RETRIEVE THE DEVICE, FORCING THE RESHEATHING. IT WAS NOTED THAT THE TIP OF THE CATHETER MOVED DURING DEPLOYMENT, IT HAD TO BE MOVED, AS IT IS A NATURAL MOVEMENT TO RETRACT THE TIP SO THE DEVICE CAN BE DEPLOYED. THE TIP REMAINED OPTIMAL DURING DEPLOYMENT UNTIL THE MOMENT OF RETRIEVAL OR RESHEATHING, WHICH CAUSED THE SYSTEM TO FAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22980309 ↗
• MalfunctionSep 5, 2025Retraction Problem; Unintended Movement; Physical Resistance/Sticking; Retraction Problem; Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FLEX WITH SHIELD (PED2) MET RESISTANCE WITH A MARKSMAN MICROCATHETER DURING RESHEATHING. THE PATIENT WAS UNDERGOING FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, ACI ANEURYSM OF THE C6 OPHTHALMIC SEGMENT WITH A MAX DIAMETER OF 8 MM AND A 4 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 3.8 MM DISTALLY AND 4.1 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED NO INJURY. IT WAS REPORTED THAT THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS USED FOR AN APPROVED INDICATION (ON-LABEL) AND THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE. DURING THE DEPLOYMENT, THE STENT NEEDED TO BE REPOSITIONED MORE DISTAL TO THE ANEURYSM, HOWEVER, ATTEMPTS TO RESHEATH IT WERE UNSUCCESSFUL AS THE MICROCATHETER NO LONGER ALLOWED THE DELIVERY SYSTEM TO BE PULLED THROUGH. RESISTANCE WAS MET, CAUSING THE MICROCATHETER TIP TO DROP FURTHER FROM THE ANEURYSM. THE PIPELINE BECAME STUCK IN THE DISTAL END OF THE MICROCATHETER. THE LOAD (SLACK) IN THE SYSTEM WAS RELEASED IN AN ATTEMPT TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22980028 ↗
• MalfunctionAug 1, 2025Material Deformation; Packaging Problem; Physical Resistance/Sticking; Material Deformation; Packaging Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT MICROCATHETER. THE KINK WAS DISCOVERED UPON REMOVAL FROM THE PACKAGING. THE GUIDEWIRE WAS NOT A MEDTRONIC PRODUCT. IT WAS ABLE TO PASS THE CATHETER HUB. THERE WAS NO DAMAGE TO THE CATHETER HUB. THE GUIDEWIRE TIP WAS SHAPED. THE GUIDEWIRE WAS NOT KINKED. THERE WAS NO PROBLEM WITH THE GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686873 ↗
• MalfunctionJul 15, 2025Break; Break

  MEDTRONIC RECEIVED A REPORT THAT A MARKSMAN MICROCATHETER HAD A DISTAL SEPARATION OR BREAK DURING USE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A STROKE. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE MIDDLE CEREBRAL ARTERY (MCA) ACCESS VESSEL DIAMETER WAS 3.5 MM. IT WAS REPORTED THAT THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). A SEPARATION OR BREAK WAS ENCOUNTERED AT THE DISTAL END OF THE MICROCATHETER DURING USE. THERE WAS NO FRICTION OR DIFFICULTY DURING INJECTION. FORCE WAS APPLIED DURING DELIVERY OR REMOVAL, HOWEVER, THE CATHETER TIP WAS NOT ENTRAPPED OR STUCK, THERE WAS NO VASOSPASM NOTED, AND THE MICROCATHETER WAS NOT STUCK INSIDE THE GUIDE CATHETER. NO SURGICAL OR MEDICINAL INTERVENTIONS WERE REQUIRED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505707 ↗
• MalfunctionApr 29, 2025Leak/Splash; Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT A MARKSMAN CATHETER LEAKED. THE PATIENT WAS UNDERGOING INTRA-ARTERIAL THERAPY (IAT). IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED DURING THE IAT PROCEDURE, THE PHYSICIAN PERFORMED A FLUSHING TEST PRIOR TO USING THE MARKSMAN PRODUCT AND OBSERVED LEAKAGE. THE DEVICE WAS THEN REPLACED WITH A NEW MARKSMAN160 OF THE SAME LOT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE DEVICES WERE PREPARED AND FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925276 ↗
• MalfunctionApr 22, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

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¿T RESOLVE THE ISSUE. THE PUSHWIRE WAS NOT DAMAGED, BUT THE CATHETER WAS DEFORMED (ACCORDIONED). THE PIPELINE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885296 ↗
• MalfunctionJan 29, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE TECH AT THE ACCOUNT TRIED TO PUT AN ARISTOTLE 14 WIRE THROUGH THE MARKSMAN CATHETER, IT WOULD NOT ADVANCE OVER THE WIRE. IT WAS PREPARED ACCORDING TO THE IFU AND WAS NOW UNABLE TO BE ADVANCED OR PULLED OUT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21267389 ↗
• MalfunctionNov 27, 2024Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE ENCOUNTERED RESISTANCE AND FELL OFF. A MARKSMAN CATHETER ENCOUNTERED RESISTANCE IN THE DISTAL END. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED LEFT OPHTHALMIC ARTERY ANEURYSM WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS: MAX DIAMETER 15 MM AND NECK WIDTH 5 MM. LANDING ZONE (ARTERY SIZE): DISTAL 3.2 MM AND PROXIMAL 3.9 MM. THE PATIENT¿S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS SEVERE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY (DIAMETER 9 MM). IT WAS REPORTED THAT THE BLOOD VESSEL C1 WAS TORTUOUS AND THE TENSION OF THE STENT WAS TOO GREAT. AFTER DEPLOYMENT, THE STENT FELL OFF. WHEN THE STENT WAS RETRIEVED INTO THE CATHETER, IT COULD NOT BE PUSHED. THE STENT WAS STUCK IN THE CATHETER, SO THE STENT AND CATHETER WERE WITHDRAWN TOGETHER. THE SECOND STENT AND CATHETER WAS VERY DIFFICULT TO PUT IN PLACE. THE TENSION WAS HUGE. WHEN PREPARING TO DEPLOY THE STENT, IT WAS FOUND THAT IT COULD NOT BE PUSHED AND THE CATHETER WAS BROKEN. THE CATHETER AND STENT WAS IMMEDIATELY WITHDRAWN. THE DISTAL END OF THE CATHETER WAS BROKEN, BUT IT DID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20802252 ↗
• MalfunctionNov 6, 2024Unintended Movement; Physical Resistance/Sticking; Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE ENCOUNTERED RESISTANCE IN THE MARKSMAN CATHETER RESULTING IN UNINTENDED MOVEMENT DURING DEPLOYMENT.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 25 MM AND A 10 MM NECK DIAMETER. THE LANDING ZONE: DISTAL: 3.5 MM AND PROXIMAL 3.8 MM.  IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL WAS STANDARD. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. IT WAS REPORTED THAT THE OPERATOR FIRST PLACED THE CATHETER FA-55160-1030 (224314029) TO THE DISTAL END OF THE PARENT ARTERY. THE DE PLOYMENT POSITION AND FEEL WERE NORMAL. THE OPERATOR FIRST SELECTED A PED-375-25 BLOOD FLOW DIVERSION DENSE MESH STENT. AFTER PASSING THROUGH THE STARTING END OF FA-55160-1030 (224314029), DURING THE DELIVERY OF PED-375-25, THE PUSHING RESISTANCE INCREASED, CAUSING THE DELIVERY CATHETER FA-55160 -1030 (224314029) FELL INTO THE ANEURYSM CAVITY ALONG WITH A SECTION OF THE STENT DURING DELIVERY, AND REPEATEDLY TRIED TO PUSH THE CATHETER TO THE DISTAL END OF THE PARENT ARTERY, BUT FAILED. IT WAS REPORTED THE PIPELINE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621050 ↗
• MalfunctionOct 22, 2024Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE ENCOUNTERED RESISTANCE AND FELL OFF. A MARKSMAN CATHETER ENCOUNTERED RESISTANCE IN THE DISTAL END. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED LEFT OPHTHALMIC ARTERY ANEURYSM WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS: MAX DIAMETER 15 MM AND NECK WIDTH 5 MM. LANDING ZONE (ARTERY SIZE): DISTAL 3.2 MM AND PROXIMAL 3.9 MM. THE PATIENT¿S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS SEVERE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY (DIAMETER 9 MM). IT WAS REPORTED THAT THE BLOOD VESSEL C1 WAS TORTUOUS AND THE TENSION OF THE STENT WAS TOO GREAT. AFTER DEPLOYMENT, THE STENT FELL OFF. WHEN THE STENT WAS RETRIEVED INTO THE CATHETER, IT COULD NOT BE PUSHED. THE STENT WAS STUCK IN THE CATHETER, SO THE STENT AND CATHETER WERE WITHDRAWN TOGETHER. THE SECOND STENT AND CATHETER WAS VERY DIFFICULT TO PUT IN PLACE. THE TENSION WAS HUGE. WHEN PREPARING TO DEPLOY THE STENT, IT WAS FOUND THAT IT COULD NOT BE PUSHED AND THE CATHETER WAS BROKEN. THE CATHETER AND STENT WAS IMMEDIATELY WITHDRAWN. THE DISTAL END OF THE CATHETER WAS BROKEN, BUT IT DID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504095 ↗
• MalfunctionOct 11, 2024Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A MARKSMAN CATHETER ENCOUNTERED RESISTANCE AND BROKE/SEPARATED. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN ACUTE ISCHEMIC STROKE. THE VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE RIGHT FEMORAL INTO THE RICA. THE PHYSICIAN TRIED TO ADVANCE THE RED 62 BUT IT WOULDN¿T TRACK SO HE INTRODUCED AND ADVANCED THE MARKSMAN AND ARISTOTLE TO USE AS A RAIL AND SUPPORT THE RED 62 FOR ADVANCEMENT INTO PLACE. ONCE RED 62 IN PLACE, THEY TRIED TO REMOVE THE WIRE TO INTRODUCE THE SOLITAIRE BUT HAD SIGNIFICANT RESISTANCE WHEN TRYING TO REMOVE WIRE. PHYSICIAN DECIDED TO REMOVE BOTH WIRE AND MARKSMAN TOGETHER OUT OF THE PATIENT. WHEN THE PRODUCTS WERE OUT OF THE BODY THE MARKSMAN WAS BROKE AND SEPARATED ON THE DISTAL END. THE ARISTOTLE WIRE WAS WELL HYDRATED AND ALL PRODUCTS PREPPED PER IFU. THE VERY DISTAL END OF THE CATHETER WAS DISCARDED BY ACCIDENT; THEREFORE, SENDING PARTIAL MARKSMAN AND ARISTOTLE 18   THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THERE WAS NO FRICTION OR DIFFICULTY DURING INJECTION. THERE WAS NO FORCE APPLIED DURING DELIVERY OR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20433957 ↗
• MalfunctionFeb 5, 2024Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PROCEDURE WAS COMPLETED BY REPLACING WITH A NEW PHENOM 21 CATHETER. THE CATHETER HAD CREASES AND WHEN IT WAS RINSED, IT WAS FOUND THAT WATER WAS LEAKING OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18641962 ↗
• MalfunctionOct 31, 2023Break; Break

  MEDTRONIC RECEIVED A REPORT THAT DURING A CODE NTR, A MARKSMAN CATHETER 160CM/10CM/30CM, REF# FA-55160-1030, LOT# 22657660, EXP. 5/17/26 WAS PREPPED AND READY TO GO INTO THE PATIENT VIA ARTERIAL ACCESS IN THE RIGHT FEMORAL ARTERY. AS THE MEDICAL DOCTOR INSERTED THE CATHETER, HE NOTICED THAT A PIECE OF THE CATHETER BROKE OFF. ALL PIECES WERE RETRIEVED. REFER TO MEDWATCH MW5146887 FOR ORIGINAL REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18038641 ↗
• MalfunctionSep 14, 2023Break; Break

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE PIPELINE WAS DEPLOYED TO THE NECK OPENING OF THE C6 SEGMENT OF THE INTERNAL CAROTID ARTERY, THE ADHESION OF THE PIPELINE TO THE WALL WAS OBSERVED UNDER FLUOROSCOPY AND IT WAS FOUND THAT THE PIPELINE COULD NOT BE OPENED. AFTER LOCKING THE Y VALVE AND REPEATEDLY PUSHING AND PULLING IT, THE PROBLEM STILL PERSISTED, SO THE PIPELINE WAS REPLACED. THE PIPELINE SYSTEM WAS REMOVED FROM THE BODY AND FOUND TO BE SEPARATED FROM THE MARKSMAN. THE PIPELINE WAS NOT USED FOR AN OFF-LABEL USE. THE PIPELINE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE MARKSMAN WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.   THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED LEFT POSTERIOR COMMUNICATING (PCOM) ARTERY ANEURYSM. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. THE LANDING ZONE ARTERY SIZE WAS 2.5MM DISTALLY AND 2.9MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED AND THE PLATELET REACTIVITY UNITS (PRU) LEVEL WAS TAKING DOUBLE ANTIBODIES 3 DAYS BEFORE THE O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17748790 ↗
• MalfunctionMay 25, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DOCTOR DIDN'T KNOW WHAT THE CAUSE OF THE RESISTANCE WAS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004295 ↗
• MalfunctionDec 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NEW INFORMATION WAS RECEIVED. THE PHYSICIAN STATED AS HE WAS ADVANCING THE CATHETER UP THE INTERNAL CAROTID, HE COULDN¿T SEE THE CATHETER TIP. HE DID A RUN FOR A ROADMAP FOR NAVIGATION AND STILL COULDN¿T SEE THE TIP OF THE CATHETER. AFTER EXAMINING THE IMAGING, HE NOTICED IT WAS DISTALLY LODGED IN A SMALL VESSEL. HE SAID THERE WAS NO REASON OR DIFFICULTY TO EXPLAIN WHY THE MARKER BAND SEPARATED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16008921 ↗
• MalfunctionJun 8, 2022Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT WHILE TREATING A STROKE WITH A MARKSMAN CATHETER THE PHYSICIAN USED A TIGERTREAVER THROUGH IT AND THE DISTAL TIP OF THE CATHETER BROKE OFF. WAS ABLE TO ASPIRATE THE TIP OUT AND IT IS IN THE IMPERATIVE CARE CLOT CONTAINER ENCLOSED WITH THE CATHETER. THE PACKAGE WAS NOT DAMAGED. THERE WAS NO EVIDENCE OF TAMPERING. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS PER IFU. THE ACCESS VESSEL WERE THE INTERNAL CAROTID ARTERY (ICA) AND THE M2 WITH A DIAMETER OF 3MM. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14638008 ↗
• MalfunctionAug 31, 2021Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL PART OF THE MARKSMAN CATHETER BROKE AND THE MARKER BAND DISLODGED. THE PATIENT WAS UNDERGOING TREATMENT FOR A A STROKE. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE ICA. IT WAS REPORTED THAT THE JET 7 CATHETER SHEARED OFF INTO THE PATIENT. THE MARKSMAN CATHETER APPEARED FRAYED UPON RETRIEVAL BUT INTACT EXCEPT FOR THE RADIOPAQUE MARKER BAND. THE MARKER BAND WAS VISUALIZED IN THE PATIENT, BUT WAS REMOVED DURING ASPIRATION WHICH WAS VERIFIED UNDER FLUOROSCOPY. THE CATHETER TIP WAS SAID TO BE ENTRAPPED/STUCK. THERE WERE NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTIONS REQUIRED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A PENUMBRA JET 7 GUIDE CATHETER AND NEURON MAX 088 SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12397325 ↗
• MalfunctionMay 4, 2021Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE MARKSMAN MICROCATHETER WAS BEING USED WITH AN EMBOTRAP DEVICE. UPON THE THIRD RETRIEVAL, IT WAS NOTED THE DISTAL PORTION OF THE MARKSMAN MICROCATHETER HAD FRACTURED. THERE HAD NOT BEEN ANY RESISTANCE EXPERIENCED, THERE WAS NO VASOSPASM, AND NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE FRACTURED PORTION WAS ON THE EMBOTRAP, AND SO THE EMBOTRAP WAS SAFELY REMOVED CONTAINING BOTH PIECES. A NEW MARKSMAN MICROCATHETER WAS USED TO COMPLETE THE CASE WITH NO FURTHER ISSUE REPORTED. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A STROKE THROMBECTOMY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769688 ↗
• MalfunctionApr 9, 2021Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MARKSMAN CATHETER WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PHYSICIAN THOUGH THE CATHETER SEEMED TO DOUBLE BACK ON ITSELF WITHIN THE PATIENT VESSEL PRIOR TO THE BREAK. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11645512 ↗
• MalfunctionMar 24, 2021Retraction Problem; Physical Resistance/Sticking

  WHEN BACKING THE CATHETER OFF WIRE, THE CATHETER BECAME STUCK. THE WHOLE CONSTRUCT HAD TO BE REMOVED FROM PATIENT DURING A CRUCIAL TIME OF TRYING TO RETRIEVE CLOTS FROM A STROKE PATIENT. NO HARM CAUSED TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11559546 ↗
• MalfunctionNov 10, 2020Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DEVICES WERE PREPARED PER THE IFU, THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE, AND THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AS A RESULT OF THE EVENT. NO FURTHER INTERVENTION WAS TAKEN AS THE MARKER PIECES UNRAVELED BUT WERE STILL INTACT IN THE CATHETER. THE CAUSE OF THE EVENT REMAINS UNKNOWN. ANCILLARY DEVICES INCLUDE 6F SHUTTLE JET 7, SYNCHRO GUIDEWIRE.

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

  MAUDE report 10819740 ↗
• MalfunctionOct 22, 2020Break

  THE MARKSMAN CATHETER TIP SHEARED DURING PROCEDURE. AFTER COMPLETION OF A CEREBRAL ANGIOGRAM AND THROMBECTOMY WHEN THE MARKSMAN CATHETER WAS REMOVED, IT WAS NOTED THAT THE TIP HAD SHEARED. IT WAS REMOVED INTACT WITH NO COMPLICATIONS TO THE PATIENT. MANUFACTURER RESPONSE FOR CATHETER, CONTINUOUS FLUSH, MARKSMAN (PER SITE REPORTER). THE REP IS AWARE AND PLANS TO PICK UP THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10717946 ↗