N/A IC71125UGRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10886704082361), received between Nov 12, 2020 and May 4, 2026 — classified as 3 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (5 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Peeled/Delaminated; Material Deformation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2026, THE PHYSICIAN OPENED THE DEVICE PACKAGING FOR THE 125CM LARGE BORE CATHETER (LBC) 71 (IC71125UG / 31633650) FOR INSPECTION. THE TIP OF THE LBC WAS FOUND TO BE ROUGH (NOT SMOOTH WITH BURRS AS SHOWN IN THE PHOTO INCLUDED IN THE COMPLAINT). THE DEVICE WAS NOT USED IN THE PATIENT. A NEW DEVICE WAS USED FOR THE PROCEDURE. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. A PHOTO WAS INCLUDED IN THE COMPLAINT. THE PHOTO WILL BE REVIEWED BY THE PRODUCT ANALYSIS TEAM. ON 29-APR-2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE REPLACEMENT DEVICE WAS ANOTHER 125CM LARGE BORE CATHETER (LBC) 71 (IC71125UG). THERE WAS NO PROCEDURE DELAY DUE TO THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071837 ↗
• MalfunctionApr 21, 2026Failure to Advance; Deformation Due to Compressive Stress

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE, THE 125CM LARGE BORE CATHETER (LBC) 71 (IC71125UG / 31794111) WAS IMPEDED AT THE C2 SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA) AND COULD NOT BE ADVANCED TO THE TARGET SITE. THE PHYSICIAN REMOVED THE LBC FROM THE PATIENT AND REPLACED IT WITH A NEW LBC TO COMPLETE THE PROCEDURE. ON 16-APR-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING THE M1 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE C1, C2, AND C4 SEGMENTS OF THE ICA WERE REPORTED TO BE TORTUOUS BLOOD VESSELS. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER (UNSPECIFIED BRAND). PER THE INFORMATION, THE INTRODUCER WAS FIRMLY INSTALLED ONTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE HEMOSTASIS VALVE (RHV) DURING THE ADVANCEMENT OF THE DEVICE. IT ALSO INDICATED THAT, ¿AFTER TAKING IT OUT, IT WAS FOUND THAT THERE WAS A SLIGHT KINK.¿ THE INFORMATION CONFIRMED THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 16-APR-2026, THE EVENT HAS BEEN DETERMINED TO BE USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24947462 ↗
• MalfunctionJan 27, 2026Crack

  THE HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE THE START OF AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN OPENED THE DEVICE PACKAGING FOR THE 125CM LARGE BORE CATHETER (LBC) 71 (IC71125UG / 31578871) AND TOOK OUT THE LBC FOR INSPECTION. IT WAS REPORTED THAT THE DISTAL END OF THE LARGE BORE CATHETER WAS FOUND CRACKED. THE DEVICE WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN REPLACED THE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO NEGATIVE PATIENT IMPACT. ON 27-JAN-2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE LOCATION OF THE REPORTED CRACK COULD NOT BE OBTAINED. NOTHING UNUSUAL WAS NOTED ON THE DEVICE PACKAGING; THE DEVICE PACKAGING IS REPORTEDLY AVAILABLE FOR RETURN. THE REPLACEMENT WAS ANOTHER 125CM LARGE BORE CATHETER 71 (IC71125UG). THE REPORTED ISSUE DID NOT RESULT IN ANY PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24190705 ↗
• MalfunctionJan 20, 2026Failure to Advance; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION, A 125CM LARGE BORE 71 CATHETER (PRODUCT CODE IC71125UG, LOT NUMBER 31512442) AND A PROWLER SELECT PLUS 150/5CM MICROCATHETER (PRODUCT CODE 606S255X, LOT NUMBER UNKNOWN) WERE DELIVERED COAXIALLY, WITH THE MICROCATHETER SUCCESSFULLY PASSING THROUGH THE END OF THE INTERNAL CAROTID ARTERY. HOWEVER, THE LARGE BORE CATHETER WAS IMPEDED AT THE END OF THE INTERNAL CAROTID ARTERY AND COULD NOT ADVANCE FURTHER. UPON REMOVAL, THE SHAFT OF THE LARGE BORE CATHETER WAS OBSERVED TO BE KINKED OR BENT. THE PHYSICIAN SWITCHED TO A NEW DEVICE TO COMPLETE THE SURGERY USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORTED PATIENT CONSEQUENCE OR ADVERSE IMPACT, AND NO PROCEDURE PROLONGATION OR DELAY OCCURRED DUE TO THE EVENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 09-JAN-2026 INDICATED THAT THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THERE WAS NO PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 12-JAN-2026 INDICATED THAT IT IS UNKNOWN IF THE PROWLER SELECT MICROCATHETER WAS REMOVED WHEN THE LARGE BORE CATHETER B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24116926 ↗
• MalfunctionDec 23, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  A HEALTHCARE PROFESSIONAL DURING AN ANGIOPLASTY PROCEDURE, A 125CM LARGE BORE 71 CATHETER (PRODUCT CODE: IC71125UG, LOT NUMBER 31578871). THE STENT, FROM ANOTHER BRAND, WAS IMPEDED AT THE PROXIMAL END OF THE CATHETER AND COULD NOT PASS THROUGH. BOTH THE STENT AND THE LARGE BORE CATHETER WERE REMOVED, AND A NEW LARGE BORE CATHETER WAS USED TO COMPLETE THE SURGERY WITH THE ORIGINAL STENT. THERE WERE NO REPORTED PATIENT CONSEQUENCES, SYMPTOMS, OR INVOLVEMENT. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 22-DEC-2025 INDICATING THAT THERE WAS NO RESISTANCE/UNUSUAL FRICTION KNOWN OR SUSPECTED. THE USER WAS NOT ABLE TO MOVE THE DEVICE AT ALL DUE TO THE RESISTANCE. THE DEVICE DID NOT BECOME DAMAGED AT ANY TIME PRIOR TO THE RESISTANCE/FRICTION. THE CONCOMITANT DEVICES USED WITH THE PRODUCT DID NOT BECOME DAMAGED AT ANY TIME. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THERE WAS NO DAMAGE ON ANY PART OF THE DEVICE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. A NOVA STENT OF SINOMED WAS USED. THE INTRODUCER WAS FULLY SEATED AND SECURED IN THE CATHETER HUB DURING INTRODUCTION OF THE DEVICE INTO THE CATHETER. NO ADDITIONAL INTERVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878029 ↗
• MalfunctionNov 4, 2025Crack; Physical Resistance/Sticking; Crack; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT PRIOR TO THE START OF AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE OUTER DEVICE PACKAGING AND THE DEVICE, A 125CM LARGE BORE CATHETER (LBC) 71 (IC71125UG / 31512442), WERE INSPECTED AND FOUND TO BE IN GOOD CONDITION. DURING THE PROCEDURE, THE 125CM LBC WAS DELIVERED IN PLACE AND A MICROCATHETER (UNSPECIFIED BRAND) WAS DELIVERED IN THE LBC. THE MICROCATHETER WAS IMPEDED IN THE MIDDLE SECTION OF THE LBC AND COULD NOT ADVANCE FURTHER. THE PHYSICIAN REMOVED THE MICROCATHETER AND THE LBC FROM THE PATIENT AND FOUND THE MIDDLE SECTION OF THE LBC TO BE CRACKED. THE PHYSICIAN REPLACED THE LBC AND THE MICROCATHETER TO COMPLETE THE PROCEDURE. ON 30-OCT-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT INFORMATION RELATED TO THE TARGET VESSEL OF THE PROCEDURE COULD NOT BE OBTAINED. THERE WAS CONTINUOUS FLUSH MAINTAINED DURING THE PROCEDURE. THERE WAS NO DAMAGE NOTED ON THE MICROCATHETER WHEN IT WAS REMOVED. THE BRAND AND SIZE OF THE MICROCATHETER COULD NOT BE OBTAINED. THE REPLACEMENT WAS ANOTHER 125CM LARGE BORE CATHETER (LBC) 71 (IC71125UG) AND THE REPLACEMENT MICROCATHETER WAS ANOTHER OF THE SAME BRAND AS THE ORIGINAL MICROCAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466655 ↗
• MalfunctionAug 19, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE HEALTHCARE PROFESSIONAL REPORTED THAT PRIOR TO THE START OF A THROMBECTOMY PROCEDURE, THE DEVICE PACKAGING FOR A 125CM LARGE BORE CATHETER (LBC) 71 (IC71125UG / 31561452) AND THE DEVICE WERE INSPECTED AND CONFIRMED TO BE IN GOOD CONDITION. THE LARGE BORE CATHETER WAS THEN USED IN THE PROCEDURE, IT WAS REPORTED THAT AFTER THE FIRST ASPIRATION TO REMOVE THE THROMBUS ON THE FIRST ATTEMPT, THE PHYSICIAN REMOVED THE LBC FROM THE PATIENT AND NOTED THAT THE DISTAL END OF THE LBC WAS COMPRESSED / FLATTENED. THE PHYSICIAN REPLACED IT WITH ANOTHER LBC TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. A PHOTO OF THE DEVICE WAS INCLUDED IN THE COMPLAINT. THE PRODUCT ANALYSIS TEAM WILL REVIEW THE PHOTO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22846243 ↗
• MalfunctionAug 19, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE HEALTHCARE PROFESSIONAL REPORTED THAT PRIOR TO THE START OF A THROMBECTOMY PROCEDURE, THE DEVICE PACKAGING FOR A 125CM LARGE BORE CATHETER (LBC) 71 (IC71125UG / 31561452) AND THE DEVICE WERE INSPECTED AND CONFIRMED TO BE IN GOOD CONDITION. THE LARGE BORE CATHETER WAS THEN USED IN THE PROCEDURE, IT WAS REPORTED THAT AFTER THE FIRST ASPIRATION TO REMOVE THE THROMBUS ON THE FIRST ATTEMPT, THE PHYSICIAN REMOVED THE LBC FROM THE PATIENT AND NOTED THAT THE DISTAL END OF THE LBC WAS COMPRESSED / FLATTENED. THE PHYSICIAN REPLACED IT WITH ANOTHER LBC TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. A PHOTO OF THE DEVICE WAS INCLUDED IN THE COMPLAINT. THE PRODUCT ANALYSIS TEAM WILL REVIEW THE PHOTO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22846093 ↗
• MalfunctionJul 3, 2025Deformation Due to Compressive Stress; Difficult to Advance; Material Twisted/Bent; Deformation Due to Compressive Stress; Difficult to Advance; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY, A LONG SHEATH (NON-J&J BRAND), AN EMBOVAC THROMBUS ASPIRATION CATHETER (IC71125CA, 31434333), A NON-J&J MICROCATHETER (MC) AND A NON-J&J MICRO-GUIDEWIRE WERE DELIVERED IN PATIENT COAXIALLY. THE LONG SHEATH AND THROMBUS ASPIRATION CATHETER WERE IMPEDED IN THE C2 SEGMENT OF INTERNAL CAROTID ARTERY AND UNABLE TO ADVANCE TO THE TARGET SITE. THE DOCTOR ONLY REMOVED THE THROMBUS ASPIRATION CATHETER, MICROCATHETER AND MICRO-GUIDEWIRE FROM THE PATIENT FOR INSPECTION. THE THROMBUS ASPIRATION CATHETER SHAFT WAS FOUND KINKED/BENT. THE DOCTOR SWITCHED TO A NEW THROMBUS ASPIRATION CATHETER TO COMPLETE THE SURGERY WITH THE SAME MICROCATHETER AND MICRO-GUIDEWIRE. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 13-JUN-2025 INDICATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THE EVENT DID NOT RESULT IN PATIENT HARM. THE TARGET VESSEL/SITE BEING TREATED WAS THE MIDDLE CEREBRAL ARTERY. THERE WAS NO BREAK IN MATERIAL INTEGRITY AT THE SITE OF THE DEFECT, SUCH AS CRACKING OR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395421 ↗
• MalfunctionJan 27, 2025Crack; Crack

  AS REPORTED BY THE FIELD, THE EMBOVAC CATHETER (IC71125CA, (B)(4).) WAS ALREADY VISIBLY BENT BELOW THE HUB IN THE PACKAGING BEFORE THE LAUNCH. THE PRODUCT WAS NOT USED IN THE PATIENT. PICTURES OF THE DEVICE WERE RECEIVED ON (B)(4).2025 SHOWING CATHETER CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21240956 ↗
• InjuryDec 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE EXCELLENT STUDY, A (B)(6) YEAR-OLD MALE (SUBJECT: (B)(6) WITH A MEDICAL HISTORY OF ATRIAL FIBRILLATION AND SMOKING (PREVIOUS), PRESENTED WITH A WITNESSED STROKE ON (B)(6) 2024 AT 08:15. THE PATIENT WAS THEN PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2024 AT 14:14. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿CARDIOEMBOLIC.¿ THE PATIENT¿S BASELINE NIHSS SCORE WAS 35 AND MODIFIED RANKIN SCALE (MRS) SCORE WAS ¿1- NO SIGNIFICANT DISABILITY. ABLE TO CARRY OUT ALL USUAL DUTIES AND ACTIVITIES.¿ ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING AN EMBOVAC IC 71, 125 CM, CE, ASP. IND. (IC71125CA/ 31338488) FOR AN OCCLUSION AT THE M1 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE PRE-PASS MTICI SCORE WAS 0. THE 1ST PASS WAS MADE USING THE DIRECT CONTACT ASPIRATION DEVICE ALONE (EMBOVAC), WHICH RESULTED IN A MTICI SCORE OF 1, WITH NO CLOT RETRIEVAL (INCUBATION TIME: ¿NA¿). DUE TO PERSISTENT CLOT, DEVICES WERE EXCHANGED, AND THE 2ND PASS WAS MADE USING A SOLITAIRE STENT-RETRIEVER, WHICH RESULTED IN A MTICI SCORE OF 3, WITH CLOT RET

  Patient problems: Intracranial Hemorrhage

  MAUDE report 20891337 ↗
• MalfunctionSep 9, 2024Material Puncture/Hole; Stretched; Material Puncture/Hole; Stretched

  AS REPORTED BY THE FIELD, DURING A THROMBECTOMY, THE USER USED THE EMBOVAC ASPIRATION CATHETER TO ASPIRATE THE THROMBUS THROUGH SEGMENT M1, THEN PULLED IT BACK, CAUSING THE STRETCH TO COLLAPSE AND ¿BREAK THE HOLE¿. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 26-AUG-2024 INDICATED THAT THERE WAS A SLIGHT PROCEDURAL DELAY DUE TO THE VENT. THE TERM OF ¿BREAK THE HOLE¿ WAS FURTHER CLARIFIED AS HAVING A ¿HOLE¿. THE DEVICE DID NOT SEPARATE INTO 2 OR MORE FRAGMENTS. ADAPT ((DIRECT ASPIRATION FIRST PASS TECHNIQUE) WAS PERFORMED IN THIS CASE. THE DEVISE WAS NOT SNAKED. THERE WAS REGULAR TORTUOSITY IN THE INTERNAL CAROTID ARTERY, CAVERNOUS SEGMENT (C4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20169961 ↗
• MalfunctionAug 14, 2024Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A MECHANICAL THROMBECTOMY TO THE MIDDLE CEREBRAL ARTERY, M1 SEGMENT, AN 125CM LARGE BORE 71 CATHETER (IC71125UG, 31026911) AND A NON J&J MICROCATHETER (MC) WERE DELIVERED IN THE PATIENT¿S BLOOD VESSEL COAXIALLY WITH THE HELP OF AN UNSPECIFIED MICRO-GUIDE WIRE. THE LARGE BORE CATHETER WAS IMPEDED AT C5-C6 OF THE INTERNAL CAROTID ARTERY AND COULD NOT BE ADVANCED FURTHER. THE PHYSICIAN USED A SECOND MICRO-GUIDEWIRE TO ASSIST IN COAXIAL DELIVERY OF THE LARGE BORE, HOWEVER, THE LARGE BORE CATHETER WAS STILL IMPEDED AND COULD NOT REACH THE TARGET POSITION. THE PHYSICIAN REMOVED THE LARGE BORE, MICROCATHETER, MICRO-GUIDEWIRES FROM THE PATIENT AND FOUND THAT THE TIP OF THE LARGE BORE CATHETER HAD BEEN COMPRESSED/ FLAT. THE PHYSICIAN CHANGED TO A NEW INTERMEDIATE CATHETER TO COMPLETE THE PROCEDURE. THE MICROCATHETER AND MICRO-GUIDEWIRES WERE NOT REPLACED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 31-JUL-2024 CONFIRMED THAT THE MICROCATHETER WAS ALREADY AT THE TARGET LOCATION WHEN THE ISSUE WAS ENCOUNTERED. THERE WERE NO PROCEDURAL DELAYS THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THE PATIENT¿S CAVERNOUS SINUS WAS TORTUOUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982482 ↗
• InjuryAug 6, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT AN EMBOVAC 125CM LARGE BORE 71 CATHETER (IC71125UG/ 31184038) WAS USED FOR A MECHANICAL THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED THE TIP OF THE EMBOVAC WAS FOUND TO BE COMPRESSED/FLAT. THE EVENT WAS REPORTED AS SUCH, ¿COMPRESSED. IT WAS REPORTED THAT DURING THE SURGERY, THE LARGE BORE CATHETER WAS USED TO ASPIRATE THE THROMBUS UNDER NEGATIVE PRESSURE FOR THE FIRST TIME. IT WAS FOUND THAT THE TIP OF THE LARGE BORE CATHETER HAD BEEN COMPRESSED/FLAT. THE PHYSICIAN REMOVED THE LARGE BORE CATHETER ALONG WITH MICROCATHETER AND STENT (BOTH ARE OTHER BRANDS) FROM THE PATIENT AND CHANGED A NEW INTERMEDIATE CATHETER (OTHER BRAND) TO COMPLETE THE SURGERY. THE MICROCATHETER AND STENT WERE NOT REPLACED. THE SURGERY WAS PROLONGED ABOUT 30 MINUTES. THE PATIENT IS IN STABLE CONDITION NOW.¿ ADDITIONAL INFORMATION WAS RECEIVED ON 17-JUL-2024. SUMMARY: PER THE INFORMATION PROVIDED, THE 30-MINUTE PROCEDURAL DELAY WAS CONSIDERED TO BE CLINICALLY SIGNIFICANT; ¿YES, RESULTING IN THE NEED TO RE-ESTABLISH THE SURGICAL PATHWAY DURING THE OPERATION.¿ THE TARGET VESSEL/SITE BEING TREATED WAS THE MIDDLE CEREBRAL ARTERY (MCA). IT WAS AL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19917862 ↗
• InjuryJan 9, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT AN 125CM LARGE BORE 71 CATHETER (IC71125UG/ 31026911) WAS USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE TO TREAT AN ANTERIOR COMMUNICATING ARTERY ANEURYSM. ¿DURING THE PROCEDURE, A LARGE BORE CATHETER WAS USED TO ESTABLISH VASCULAR ACCESS. WHEN THE CATHETER WAS DELIVERED TO C3-C4 SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY, THROMBUS WAS FOUND IN THE VESSEL WALL OF THE C3 SEGMENT, AS WELL AS IN THE DISTAL END OF THE VESSEL. PHYSICIAN ASPIRATED THE THROMBUS WITH THE CATHETER AND WHEN WITHDRAWING THE CATHETER OUT OF PATIENT BODY, TRANSPARENT DEBRIS WAS FOUND TO BE ATTACHED TO THE TIP OF THE CATHETER. AFTER PHYSICIAN SWITCHED ANOTHER BRAND OF INTERMEDIATE CATHETER TO ASPIRATE THE THROMBUS, A NEW LARGE BORE CATHETER WAS REPLACED, AND THEN COILS WERE FILLED IN THE ANEURYSM TO COMPLETE THE PROCEDURE.¿ NO FURTHER INFORMATION WAS MADE AVAILABLE AT THE TIME OF THIS REVIEW. ADDITIONAL INFORMATION WAS RECEIVED ON 25-DEC-2023. SUMMARY: PER THE INFORMATION, A CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE, THERE WERE NO SIGNS OF DAMAGE TO THE DEVICE PRIOR TO USE, AND THE CATHETER WAS FLUSHED BEFORE USE. INFORMATION COULD NOT BE OBTAIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475518 ↗
• MalfunctionSep 18, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE, THE PHYSICIAN FLUSHED THE COMPLAINT DEVICE, A LARGE BORE CATHETER (IC71125UG / 31005088) WITH SALINE AND OBSERVED THAT FLUID ESCAPED FROM THE PROXIMAL END OF THE CATHETER. WHEN THE PHYSICIAN REMOVED THE CATHETER FROM THE PATIENT¿S ANATOMY, THE PROXIMAL AREA OF THE CATHETER WAS OBSERVED TO BE BROKEN. A PHOTO OF THE DEVICE AS INCLUDED IN THE COMPLAINT. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 15-SEP-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PATIENT IS A 72-YEAR-OLD MALE WITH A HISTORY OF DIABETES, HYPERTENSION, AND CEREBRAL INFARCTION. THE TARGET VESSEL OF THE THROMBECTOMY PROCEDURE WAS THE OPHTHALMIC SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY (ICA). THE REPLACEMENT OF DEVICE USED TO COMPLETE THE PROCEDURE WAS AN AXS CATALYST® 6 CATHETER (STRYKER). NOTHING UNUSUAL WAS NOTED ABOUT THE SYSTEM PRIOR TO USE; THE LARGE BORE CATHETER DEVICE WAS PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THE INFORMATION CONFIRMED THAT THERE WAS NO ADVERSE / NEGATIVE PATIENT IMPACT AS A RESULT OF THE REPORTED ISSUE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17770001 ↗
• MalfunctionMay 5, 2023Component or Accessory Incompatibility; Component or Accessory Incompatibility

  THE HEALTHCARE PROFESSIONAL REPORTED DURING THE PREPARATION PROCESS FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN OPENED THE DEVICE PACKAGING FOR THE COMPLAINT DEVICE, A 125CM LARGE BORE 71 CATHETER (IC71125UG / 30910652) AND FOUND THE ROTATING MALE LUER CONNECTOR DOES NOT CONNECT WITH THE HEMOSTASIS VALVE FEMALE LUER. THE LARGE BORE CATHETER WAS NOT USED IN THE PATIENT. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16882310 ↗
• MalfunctionNov 4, 2022Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE, THE 125CM LARGE BORE 71 CATHETER (IC71125UG / 30775608) WAS IMPEDED IN THE SHEATH AND COULD NOT ADVANCE ANY FURTHER. THE PHYSICIAN INSPECTED THE CATHETER AND FOUND THE TIP OF IT WAS COMPRESSED / KINKED. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. A PHOTO OF THE CATHETER WAS INCLUDED IN THE COMPLAINT. ON 12-OCT-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET VESSEL WAS THE BASILAR ARTERY, POSTERIOR CIRCULATION. RELEVANT ANATOMICAL INFORMATION INDICATED VASCULAR DISSECTION WITH THROMBUS. THE PROCEDURE WAS A DIRECT ASPIRATION FIRST PASS TECHNIQUE (ADAPT). THE DEVICE WAS NOT SNAKED (ADVANCED WITHOUT WIRE / MICROCATHETER). IT WAS NOT KNOWN IF AN ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICE. THERE WAS NO BREAK IN THE DEVICE INTEGRITY AT THE SITE OF THE REPORTED DEFECT; THE COMPLAINT DEVICE DID NOT SEPARATE INTO TWO OR MORE PIECES. NO ADDITIONAL INTERVENTION WAS NEEDED TO REMOVE THE DEVICE FROM THE PATIENT. THE REPORTED ISSUE DID NOT RESULT IN ANY CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE COMPLAINT DEVICE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15736251 ↗
• MalfunctionNov 4, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE FIELD, DURING THE USE OF A 125CM LARGE BORE 71 CATHETER (IC71125UG, 30521668) FOR A STROKE INTERVENTION, THE PHYSICIAN NOTED THAT DURING THE PREPPING OF THE CATHETER, THERE WAS LEAKAGE AIR/FLUIDS NEAR THE HUB OF THE CATHETER. WHEN ASKED IF IT CAME OUT OF THE PACKAGING WITH A KINK, HE SAID THAT HE BELIEVED THERE WAS A CHANCE THAT THE CATHETER MAY HAVE BEEN MISHANDLED ON THE BACK TABLE BY A TECHNICIAN. THE PROCEDURE WAS COMPLETED BY USING A DIFFERENT PRODUCT. IT IS POSSIBLE THAT EXCESSIVE FORCE WAS USED ON THE DEVICE DURING THE HANDLING/PREPPING OF THE DEVICE. THERE WAS NO PROLONGATION DURING THE PROCEDURE DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12750584 ↗
• MalfunctionNov 12, 2020Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A THROMBECTOMY CASE, AND FOLLOWING CLOT ASPIRATION SUCCESS, UPON THE REMOVAL OF A 125CM LARGE BORE 71 CATHETER - LBC (IC71125UG, 30379768) FROM A CEREBASE LONG GUIDE SHEATH, THE PHYSICIAN NOTICED AN IRREGULARITY IN THE DISTAL 3CM SEGMENT OF LBC. UPON INSPECTION, THE LBC WAS ELONGATED/STRETCHED, WHICH THE DISTAL SEGMENT SIDEWALL APPEARED TO HAVE POSSIBLY SEPARATE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10829168 ↗