TRUFILLRecalls & reported problems across all models

We found 3 models of TRUFILL by Cerenovus, Inc. in the FDA's device registry (GUDID). Together they are named in 50 adverse event reports in the FDA's MAUDE database, received between Aug 15, 2017 and Jun 16, 2026 — classified as 14 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (17 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported TRUFILL problems

TRUFILL models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TRUFILL 631-500

  tissue adhesive for use in embolization of brain arteriovenous malformations
  26 reports
• TRUFILL 635-002

  DEVICE, NEUROVASCULAR EMBOLIZATION
  19 reports
• TRUFILL 632500NA

  tissue adhesive for use in embolization of brain arteriovenous malformations
  5 reports

Recent TRUFILL adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Unexpected Color

  THE HEALTHCARE PROFESSIONAL REPORTED THAT PRIOR TO THE START OF AN ENDOVASCULAR EMBOLIZATION TARGETING THE MIDDLE MENINGEAL ARTERY (MMA), THE PHYSICIAN WAS GOING TO USE THE TRUFILL. HE OPENED THE BOX FOR THE TRUFILL¿ N-BCA 1-GRAM KIT LIQUID EMBOLIC SYSTEM (632500NA / MG3053), AND EVERYTHING WAS INTACT. THE PHYSICIAN WENT THROUGH THE PROCEDURAL STEPS TO PREP THE GLUE AND WHEN HE FILLED THE SYRINGE WITH DEXTROSE 5% IN WATER (D5W), HE LET IT SIT FOR A BIT WHILE CHECKING THE CATHETER POSITION. IT WAS THEN THE PHYSICIAN NOTICED THAT THE D5W IN THE SYRINGE BECAME CLOUDY AND FOAMY. THE ISSUE WAS NOTICED BEFORE USING THE SYRINGE IN THE PROCEDURE. THERE WAS NO IMPACT ON THE PATIENT. ON 08-JUN-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE REPLACEMENT WAS ANOTHER TRUFILL¿ N-BCA 1-GRAM KIT LIQUID EMBOLIC SYSTEM (632500NA). THERE WERE NO DISCREPANCIES OR ABNORMALITIES NOTED WITH ANY OF THE COMPONENTS PRIOR TO USE OR DURING MIXING. THE INFORMATION CONFIRMED THERE WAS NO NEGATIVE PATIENT IMPACT. THERE WAS A SLIGHT DELAY IN GETTING [THEIR OWN] SYRINGE KIT BUT NOT ANYTHING PROLONGED. ON 16-JUN-2026, ADDITIONAL INFORMATION WAS OBTAINED. PER THE INFORMATION, THE SYRING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25521781 ↗
• MalfunctionApr 21, 2026Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE LUER LOCK ON THE SYRINGE OF THE TRUFILL¿ N-BCA 1-GRAM KIT LIQUID EMBOLIC SYSTEM (632500NA / MF7746) WAS FAULTY AND AS A RESULT THE GLUE LEAKED OUT OF THE SYRINGE WITH THE SELF-PIERCING LUER LOCK. THE PROCEDURE WAS REPORTED TO HAVE SUCCESSFULLY COMPLETED WITHOUT ANY DELAY. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. THERE WAS NO DELAY IN THE PROCEDURE. ON 15-APR-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING THE MIDDLE MENINGEAL ARTERY (MMA). THE REPORTED ISSUE OCCURRED DURING THE MIXING OF THE GLUE; NO PATIENT WAS INVOLVED. THE PROCEDURE WAS COMPLETED WITH THE USE OF A NEW TRUFILL¿ N-BCA 1-GRAM KIT. THERE WAS ZERO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945506 ↗
• MalfunctionMar 10, 2026Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE SYRINGE IN THE TRUFILL¿ N-BCA 1-GRAM KIT LIQUID EMBOLIC SYSTEM (632500NA / MF5012) WAS FAULTY AND THE GLUE CAME OUT OF THE SYRINGE. THE ISSUE WAS DISCOVERED BEFORE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24562294 ↗
• MalfunctionJan 13, 2026Device Ingredient or Reagent Problem; Unexpected Color

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PREPPING OF A TRUFILL N-BCA-1 GRAM KIT (PRODUCT CODE: 631500, LOT NUMBER: MD3674), THE MIXTURE OF N-BCA AND ETHIODIZED OIL APPEARED CLOUDY AND NOT STICKY AS USUAL AFTER BEING LEFT ON A SEPARATE TABLE FOR APPROXIMATELY 45 MINUTES. THE MIXTURE WAS STIRRED USING THE BACK OF A SYRINGE PLUNGER, AND UPON ATTEMPTED DRAW-UP INTO A SYRINGE, SMALL THICKER, PARTICULATE-APPEARING AREAS WERE OBSERVED. DUE TO THIS APPEARANCE, THE PRODUCT WAS NOT USED, AND A NEW BOX OF THE SAME PRODUCT WAS OPENED INSTEAD. THERE WAS NO PATIENT INVOLVEMENT OR CONSEQUENCE, AND THE COMPLAINT DEVICE WAS NOT USED IN THE PROCEDURE. ADDITIONAL EVENT INFORMATION RECEIVED ON 05-JAN-2025 INDICATED/CLARIFIED THAT THE N-BCA WAS PREPARED IN A STERILE METAL MIXING CUP, PER THE HOSPITAL¿S STANDARD PROCESS. THE MIXTURE CONSISTED OF 4ML ETHIODIZED OIL AND N-BCA. THE MIXTURE WAS STIRRED USING THE BACK OF A SYRINGE PLUNGER, NOT A METAL ROD, AS PER USUAL PROTOCOL. THE PREPARED MIXTURE WAS LEFT ON THE SEPARATE EMBOLIC TABLE FOR APPROXIMATELY 45 MINUTES BEFORE ATTEMPTED DRAW-UP VIA NEW SYRINGE. WHEN THE TECHNOLOGIST ATTEMPTED TO DRAW THE MIXTURE INTO A SYRINGE, THE MIXTURE APPEARED CLO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053940 ↗
• MalfunctionNov 17, 2025Unexpected Color; Unexpected Color

  A HEALTHCARE PROFESSIONAL REPORTED THAT PRIOR TO GETTING ACCESS IN MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION, THE PHYSICIAN WENT TO MIX UP TRUFILL N-BCA-1 GRAM KIT (631500, MC4030) TRUFILL NBCA FOR THE PROCEDURE. WHILE HE WAS DRAWING UP THE NBCA FROM THE TUBE, HE NOTICED THAT THE COLOR AND CONSISTENCY WAS OFF FROM NORMAL. AT THIS POINT HE DISCARDED THE ORIGINAL PRODUCT AND OPENED A NEW KIT. THE EVENT DID NOT OCCUR DURING STERILE PROCESSING AND THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 10-NOV-2025 AND 13-NOV-2025 INDICATED THAT THE NBCA GLUE WAS DISCOLORED. THE USER NOTICED AS HE WAS DRAWING THE GLUE OUT OF THE TUBE INTO A SYRINGE. IT WAS NEVER MIXED WITH THE OTHER COMPONENTS. IT WAS CONFIRMED THAT THE LIPOIDAL WAS NOT IMPLICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23571984 ↗
• MalfunctionSep 2, 2025Chemical Problem; Chemical Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN WAS USING A 156CM HEADWAY® DUO MICROCATHETER (TERUMO NEURO) TO DELIVER THE TRUFILL¿ N-BCA 1-GRAM KIT LIQUID EMBOLIC SYSTEM (632500NA / M9571J). THE TECH AT THE TABLE NOTICED SIGNIFICANT REFLUX BACK ALONG THE LENGTH OF THE CATHETER AND POINTED IT OUT TO THE PHYSICIAN. HE SUGGESTED THAT SHE PULL BACK ON HER CATHETER TO MAKE SURE IT WAS STILL MOVING FREELY. PHYSICIAN SAID IT WAS FINE AND CONTINUED HER INJECTION. ONCE THE PHYSICIAN COMPLETED THE INJECTION, SHE TRIED TO REMOVE THE HEADWAY DUO MICROCATHETER, AND IT WAS STUCK. THE PHYSICIAN CONTINUED TO PULL, THE MICROCATHETER WAS REMOVED, BUT IT WAS NOTED THAT THE TIP OF THE MICROCATHETER HAD DETACHED AND WAS IN THE PATIENT. THE PORTION OF THE MICROCATHETER THAT REMAINED IN THE PATIENT WAS NOT INTRACRANIAL, SO NO ATTEMPT WAS MADE TO REMOVE IT SURGICALLY. THE REPORTER STATED THAT THE PHYSICIAN WAS ¿CERTAIN THAT THE [MICROCATHETER] WAS THE PROBLEM.¿ THE PATIENT IS REPORTED TO BE DOING ¿FINE.¿ THE PROCEDURE WAS COMPLETED WITHOUT ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939548 ↗
• MalfunctionAug 26, 2025Unexpected Color; Unexpected Color

  IT WAS REPORTED THAT THE PHYSICIAN AND THE LAB STAFF ARE EXPERIENCED WHEN IT COMES TO THE MIXING AND USAGE OF THE TRUFILL NBCA. DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE THAT WAS USING A TRUFILL® N-BCA LIQUID EMBOLIC SYSTEM-1 GRAM KIT (631500 / M85H78), AFTER MIXING THE NBCA AND ETHIODIZED OIL, THE PHYSICIAN AND LAB NOTICED A MILKY CONSISTENCY. THIS WAS AN INDICATION THAT THE MIXTURE HAD COME INTO CONTACT WITH AN IONIC SUBSTANCE, LIKE BLOOD, SALINE OR CONTRAST MEDIA. IT WAS REPORTED THAT THE TECH ¿FEELS SURE THAT DID NOT HAPPEN.¿ THEY DISCARDED THE FIRST KIT / MIXTURE AND USED ANOTHER TRUFILL NBCA KIT WITHOUT ANY ISSUE. THE MIXTURE WITH THE REPORTED ISSUE WAS NEVER USED; THE CASE WAS COMPLETED WITH A NEW TRUFILL KIT. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT OR ANY DELAY. ON 22-AUG-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THERE WERE NO DISCREPANCIES OR ABNORMALITIES NOTED WITH ANY OF THE COMPONENTS PRIOR TO USE OR DURING MIXING. IT IS NOT KNOWN IF THE LOT NUMBER OF THE NBCA KIT USED TO COMPLETE THE PROCEDURE IS FROM THE SAME LOT NUMBER: (M85H78). THE REPORTED ISSUE DID NOT RESULT IN ANY PROCEDURE DELAY. ON 26-AUG-2025, ADDITIONAL INFORMATION WAS RECEIVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22900881 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE MEMBRANE STUDY, A 77-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY OF CARDIAC ARRHYTHMIA, HEADACHES, CONTROLLED HYPERTENSION, UNDERWENT EVACUATION OF A CHRONIC SUBDURAL HEMATOMA (SDH) VIA TWO BURR HOLES PLACEMENT FOR A LEFT FRONTAL SUBDURAL HEMATOMA WITH PARIETAL INVOLVEMENT ON (B)(6) 2023. THE PATIENT WAS RANDOMIZED INTO THE SURGICAL AND MMA EMBOLIZATION COHORT OF THE STUDY. THE PATIENT¿S BASELINE MARKWALDER GRADING SCALE (MGS) SCORE WAS 0 AND THE MODIFIED RANKIN SCALE (MRS) SCORE WAS 1. THE SDH THICKNESS WAS 10.5MM. ON (B)(6) 2023, THE PATIENT UNDERWENT MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION VIA RIGHT FEMORAL ACCESS. THE TRUFILL® N-BCA LIQUID EMBOLIC SYSTEM-1 GRAM KIT (631500 / M39Z36) (3:1 OIL: N-BCA RATIO) WAS DELIVERED WITHOUT REACHING MIDLINE VIA AN ECHELON 10 (MEDTRONIC). THE ANTERIOR BRANCH OF THE MMA WAS EMBOLIZED. NON-TARGET VESSEL EMBOLIZATION DID NOT OCCUR. IN THE OPINION OF THE TREATING PHYSICIAN, THE EMBOLIZATION WAS SUCCESSFUL. THE PATIENT WAS DISCHARGED ON (B)(6) 2023. THE MINI-MENTAL STATE EXAM (MMSE), MARKWALDER GRADING SCALE (MGS), AND MODIFIED RANKIN SCALE (MRS) ASSESSMENTS WERE NOT PERFORMED. ON (B)(6) 2023, THE PATIENT EXPERIE

  Patient problems: Convulsion/Seizure

  MAUDE report 21913314 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE MEMBRANE STUDY, A 52-YEAR-OLD MALE (SUBJECT (B)(6)) WITH A MEDICAL HISTORY OF HEADACHES AND PREVIOUS HEAD INJURY WITHIN THE PAST 12 MONTHS, UNDERWENT MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION OF A RIGHT PARIETAL SUBDURAL HEMATOMA (SDH) WITH FRONTAL INVOLVEMENT WITH TWO BURR HOLE PLACEMENT ON (B)(6) 2022. THE PATIENT WAS RANDOMIZED INTO THE SURGICAL AND MMA EMBOLIZATION COHORT OF THE STUDY. THE PATIENT¿S BASELINE MARKWALDER GRADING SCALE (MGS) SCORE WAS 1 AND THE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. THE SDH THICKNESS WAS 9.7MM. THE MMA EMBOLIZATION STUDY PROCEDURE WAS PERFORMED ON (B)(6) 2022 VIA RIGHT FEMORAL ACCESS. TRUFILL N-BCA-1 GRAM KIT (631500 / JM3688) (2.2:1 OIL: N-BCA RATIO) WAS DELIVERED BEYOND MIDLINE VIA AN ECHELON 10 MICROCATHETER (MEDTRONIC) AND A MARATHON MICROCATHETER (MEDTRONIC). THE ANTERIOR AND POSTERIOR BRANCHES OF THE MMA WERE EMBOLIZED. IN THE OPINION OF THE TREATING PHYSICIAN, THE EMBOLIZATION WAS SUCCESSFUL. THE PATIENT WAS DISCHARGED HOME FOR SELF-CARE ON (B)(6) 2022 WITH A MINI-MENTAL STATE EXAM (MMSE) SCORE OF 30, A MARKWALDER GRADING SCALE (MGS) SCORE OF 1, AND A MODIFIED RANKIN SCALE (MRS) SCORE OF 2. ON (B)(6) 2022, 16 DAYS AFT

  Patient problems: Convulsion/Seizure; Headache

  MAUDE report 21912926 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE MEMBRANE STUDY, A 79-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY OF HYPERTENSION (CONTROLLED), SEIZURES, PREVIOUS SMOKER, CORONARY ARTERY DISEASE (CAD), AND VALVE DISEASE/DYSFUNCTION, UNDERWENT EVACUATION OF A CHRONIC SUBDURAL HEMATOMA (SDH) VIA ONE BURR HOLE AND EXTERNAL VENTRICULAR DRAINS (EVD) PLACEMENT FOR A LEFT FRONTAL SUBDURAL HEMATOMA ON (B)(6) 2022. THE PATIENT WAS RANDOMIZED INTO THE SURGICAL AND MMA EMBOLIZATION COHORT OF THE STUDY. THE PATIENT¿S BASELINE MARKWALDER GRADING SCALE (MGS) SCORE WAS 1 AND THE MODIFIED RANKIN SCALE (MRS) SCORE WAS 2. THE SDH THICKNESS WAS 25.0MM. ON (B)(6) 2022, THE PATIENT UNDERWENT MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION VIA RIGHT RADIAL ACCESS. THE TRUFILL® N-BCA LIQUID EMBOLIC SYSTEM-1 GRAM KIT (631500 / JM5177) (4:1 OIL: N-BCA RATIO) WAS DELIVERED WITHOUT REACHING MIDLINE VIA A HEADWAY DUO MICROCATHETER (MICROVENTION). THE ANTERIOR BRANCH OF THE MMA WAS EMBOLIZED. NON-TARGET VESSEL EMBOLIZATION DID NOT OCCUR, AND THE N-BCA WAS INJECTED INTO THE BLOOD VESSEL BEYOND THE TIP OF THE MICROCATHETER. IN THE OPINION OF THE TREATING PHYSICIAN, THE EMBOLIZATION WAS SUCCESSFUL. THE PATIENT WAS DISCHARGED ON (B)(6)

  Patient problems: Pulmonary Embolism

  MAUDE report 21912906 ↗
• MalfunctionAug 6, 2024Chemical Problem; Chemical Problem

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, THE GLUE OF A TRUFILL N-BCA-1 GRAM KIT (631500, M25F70) BECAME OCCLUDED INSIDE THE CATHETER. SURGERY WAS DELAYED DUE TO THE EVENT. THE UNSPECIFIED MICROCATHETER WAS REMOVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19917996 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE MEMBRANE STUDY, A 72-YEAR-OLD MALE SUBJECT WITH A HISTORY OF CONGESTIVE HEART FAILURE, CORONARY ARTERY DISEASE (CAD), HEADACHES, HEAD INJURY WITHIN THE PAST 12 MONTHS, CONTROLLED HYPERTENSION (10 YEARS), PREVIOUS SMOKER, TRANSIENT ISCHEMIC ATTACK (TIA), VALVE DISEASE/DYSFUNCTION WAS RANDOMIZED INTO THE NON-SURGICAL AND MMA EMBOLIZATION COHORT OF THE STUDY. THE PATIENT¿S BASELINE MARKWALDER GRADING SCALE (MGS) SCORE WAS 1 AND THE MODIFIED RANKIN SCALE (MRS) SCORE WAS 2. ON (B)(6) 2023, THE PATIENT UNDERWENT MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION OF A RIGHT FRONTAL SUBDURAL HEMATOMA (SDH) WITH PARIETAL INVOLVEMENT. THE PROCEDURE WAS VIA RIGHT FEMORAL ACCESS. THE TRUFILL® N-BCA LIQUID EMBOLIC SYSTEM-1 GRAM KIT (631500 / M16Z21) (5:1 OIL: N-BCA RATIO) WAS DELIVERED TO MIDLINE VIA A HEADWAY DUO MICROCATHETER (MICROVENTION). THE ANTERIOR AND POSTERIOR BRANCHES OF THE MMA WERE EMBOLIZED. IN THE OPINION OF THE TREATING PHYSICIAN, THE EMBOLIZATION WAS SUCCESSFUL. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2023 WITH A MINI-MENTAL STATE EXAM (MMSE) SCORE OF 28, A MARKWALDER GRADING SCALE (MGS) SCORE OF 1, AND A MODIFIED RANKIN SCALE (MRS) SCORE O

  Patient problems: Convulsion/Seizure

  MAUDE report 19576281 ↗
• MalfunctionJun 18, 2024Chemical Problem; Chemical Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION TARGETING THE MIDDLE MENINGEAL ARTERY, THE PHYSICIAN WAS USING THE TRUFILL N-BCA 1 GRAM KIT (631500 / M64G35). THE PHYSICIAN INJECTED A RATIO OF FOUR-TO-ONE ETHIODIZED OIL TO GLUE AND WHEN HE REMOVED THE MICROCATHETER, THE GLUE DID NOT POLYMERIZE AND IT DRIFTED DISTALLY TO A NON-TARGET AREA. THE PHYSICIAN DID ANOTHER INJECTION WITH THIS SAME MIXTURE OF GLUE AND EXPERIENCED THE SAME RESULT. HE THEN OPENED ANOTHER BOX OF TRUFILL N-BCA AND MIXED THE SAME RATION OF OIL-TO-GLUE; THIS TIME, THE GLUE POLYMERIZED APPROPRIATELY. THE PHYSICIAN STATED THAT THERE WAS ¿SOMETHING WRONG WITH THE FIRST KIT OF GLUE AND HE WOULD LIKE IT REPLACED.¿ THERE WAS NO REPORT OF ANY PATIENT HARM. ON 17-JUN-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PATIENT IS AN 8-YEAR-OLD MALE WHO WAS TREATED DUE TO A SPONTANEOUS SUB-DURAL BLEED. THERE WERE NO DISCREPANCIES NOR ABNORMALITIES NOTED WITH ANY OF THE COMPONENTS PRIOR TO USE OR DURING MIXING. THE MICROCATHETER USED WAS AN ECHELON¿ 14 MICROCATHETER (MEDTRONIC). THE PHYSICIAN USED A NEW ECHELON 14 MICROCATHETER FOR EVERY INJECTION. THE REPLACEMENT BOX WAS FROM LO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563682 ↗
• MalfunctionMar 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, RELATING TO 1 NBCA, TA, OIL, & ACCESSORIES (632500NA, UNKNOWN LOT), THE 1CC SYRINGE IN PARTICULAR BOTH FOR INJECTION AND MIXING, "THE PLUNGER IS WEAK AND IT'S NOT A TIGHT FIT SO THE TRUFILL CASE LEAK OUT THE BACK OF THE SYRINGE". NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977626 ↗
• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE MEMBRANE STUDY, AN 82-YEAR-OLD FEMALE (SUBJECT (B)(6)) WITH A MEDICAL HISTORY OF CORONARY ARTERY DISEASE AND HYPERTENSION (CONTROLLED), UNDERWENT MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION OF A LEFT FRONTAL SUBDURAL HEMATOMA (SDH) WITH TEMPORAL AND PARIETAL INVOLVEMENT ON (B)(6) 2023. THE PATIENT WAS RANDOMIZED INTO THE NON-SURGICAL AND MMA EMBOLIZATION COHORT OF THE STUDY. THE PATIENT¿S BASELINE MARKWALDER GRADING SCALE (MGS) SCORE WAS 0 AND THE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. THE SDH THICKNESS WAS 11. THE MMA EMBOLIZATION STUDY PROCEDURE WAS PERFORMED ON (B)(6) 2023 VIA RIGHT FEMORAL ACCESS. TRUFILL N-BCA-1 GRAM KIT (631500/M4378T) (4:1 OIL: N-BCA RATIO) WAS DELIVERED TO MIDLINE VIA A HEADWAY DUO (MICROVENTION). THE ANTERIOR AND POSTERIOR BRANCHES OF THE MMA WERE EMBOLIZED. IN THE OPINION OF THE TREATING PHYSICIAN, THE EMBOLIZATION WAS SUCCESSFUL. THE EVENT OF ¿INCREASED CONFUSION,¿ WHICH STARTED ON 10-NOV-2023, WAS ASSESSED BY THE PI AS A SERIOUS, SEVERE ADVERSE EVENT, AND AS NOT RELATED TO THE STUDY DEVICE, POSSIBLY RELATED TO THE MMA EMBOLIZATION PROCEDURE, NOT RELATED TO THE MEDICATION USED TO TREAT THE SUBDURAL HEMATOMA (SDH), AND POSSIBLY RELATE

  Patient problems: Confusion/ Disorientation; Convulsion/Seizure; Stroke/CVA

  MAUDE report 18239745 ↗

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