OBSIDIORecalls & reported problems across all models

We found 2 models of OBSIDIO by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between Nov 20, 2023 and Feb 10, 2026 — classified as 2 deaths, 23 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (17 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

OBSIDIO recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 20, 2024Open, Classified

   An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. The most serious and the most common adverse health consequence, reasonably foreseeable to occur, is the need to perform major surgery such as bowel resection and/or diverting colostomy. Therefore, Boston Scientific does not recommend that the aliquot technique be used to deliver the Obsidio device for lower GI bleed embolization procedures.

   Z-1374-2024 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

Most reported OBSIDIO problems

OBSIDIO models

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

• OBSIDIO™ M0013972101010

  Device, Vascular, for Promoting Embolization
  1 recall26 reports
• OBSIDIO™ M0013972001010

  Device, Vascular, for Promoting Embolization
  1 recall2 deaths5 reports

Recent OBSIDIO adverse event reports

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

• MalfunctionFeb 10, 2026Material Separation

  IT WAS REPORTED THAT MATERIAL SEPARATION AND NON-TARGET EMBOLIZATION OCCURRED WITH NO SEQUELAE. OBSIDIO WAS SELECTED FOR MID PROXIMAL SPLENIC EMBOLIZATION OF A PSEUDOANEURYSM, IN COMBINATION WITH EMBOLD, INTERLOCK AND NON-BOSTON SCIENTIFIC COILS. TWO SYRINGES OF OBSIDIO WERE USED. THE PATIENT DID NOT HAVE NORMAL ANATOMY, AND A PREVIOUSLY REPLACED HEPATIC OFF THE SMA WHICH WAS BELIEVED TO BE FINE. NON-TARGET EMBOLIZATION WAS EXPERIENCED THROUGH A FEEDER TO THE DORSAL PANCREATIC VESSEL THAT HAD ENLARGED AND SOME OF THE OBSIDIO DID GO TO THE LIVER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT MADE A FULL RECOVERY. A 2.4 NON-BOSTON SCIENTIFIC MICROCATHETER WAS ALSO USED FOR THIS CASE.

  Patient problems: Embolism/Embolus

  MAUDE report 24308657 ↗
• MalfunctionJan 14, 2026Material Separation; Infusion or Flow Problem

  IT WAS REPORTED THAT MATERIAL SEPARATION OCCURRED. OBSIDIO WAS SELECTED FOR A RENAL EMBOLIZATION PROCEDURE. OBSIDIO WAS INJECTED INTO AN UPPER POLE RENAL BRANCH. THE PHYSICIAN BEGAN REFLUXING INTO THE 155CM TRUSELECT BERN MICROCATHETER. WITHIN APPROXIMATELY 20-30 SECONDS OF THE CATHETER BEING OCCLUSIVE, OBSIDIO REFLUXED, AND THE MICROCATHETER WAS PULLED BACK. WHILE PULLING BACK THE MICROCATHETER, APPROXIMATELY 1CM OF OBSIDIO WAS NOTICED ON THE DISTAL PORTION OF THE MICROCATHETER. AN ATTEMPT WAS MADE TO LET THE CATHETER SIT NEAR THE PROXIMAL PORTION OF THE OBSIDIO 'PACK' TO SEE IF THE BLOOD FLOW WOULD TAKE THE MATERIAL OFF THE CATHETER, WHICH DID NOT WORK. THE MICROCATHETER WAS QUICKLY PULLED OUT AND WHILE DOING SO, THE 1CM OF OBSIDIO WAS STILL ON THE CATHETER TIP EVENTUALLY SHEARED OFF AND WENT INTO A LOWER POLE RENAL BRANCH AND EVENTUALLY FRAGMENTED INTO PIECES, WHICH WENT INTO MULTIPLE BRANCHES WITHIN THE KIDNEY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT AND THE PATIENT IS EXPECTED TO FULLY RECOVER. IT WAS FURTHER REPORTED THAT THE VESSEL SIZE WAS UNDER 3MM. THE DELIVERY TECHNIQUE WAS STANDARD USING A .021 INNER DIAMETER TRUSELECT BERN MICROCATHETER. NO INTERVE

  Patient problems: Embolism/Embolus

  MAUDE report 24075993 ↗
• MalfunctionDec 4, 2025Migration; Migration

  IT WAS REPORTED THAT MIGRATION OCCURRED. OBSIDIO WAS SELECTED FOR USE IN A SPLENIC EMBOLIZATION PROCEDURE. OBSIDIO WAS USED OFF LABEL FOR THE VESSEL SIZE AND TRAVELED OUTSIDE THE DESIRED AREA OCCLUDED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE DESIRED AMOUNT OF OBSIDIO THAT TRAVELED OUTSIDE THE PARAMETERS WAS INTENDED AND PURPOSEFUL AND THE PATIENT DID NOT EXPERIENCE ANY HARM.

  Patient problems: Embolism/Embolus

  MAUDE report 23722659 ↗
• InjuryNov 19, 2025Activation, Positioning or Separation Problem; Infusion or Flow Problem; Poor Visibility; Activation, Positioning or Separation Problem; Infusion or Flow Problem; Poor Visibility

  IT WAS REPORTED THAT INSUFFICIENT FORMATION OF THE OBSIDIO EMBOLIC OCCURRED, REQUIRING AN ADDITIONAL DEVICE. THIS OBSIDIO CONFORMABLE EMBOLIC WAS SELECTED FOR USE DURING A RETROPERITONEAL EMBOLIZATION PROCEDURE. THE TARGET VESSEL WAS LOCATED IN THE LOW, DISTAL LEFT SIDE OF RETROPERITONEUM AND THE VESSEL SIZE WAS 1-2MM PER THE PHYSICIAN. DURING THE PROCEDURE, THE PHYSICIAN WAS AT THE DISTAL VESSEL THEY WISHED TO EMBOLIZE AND USED A TRUSELECT 130CM MICROCATHETER. THE OBSIDIO CONFORMABLE EMBOLIC WAS ATTACHED TO THE MICROCATHETER USING WET-TO-WET TECHNIQUE. THE PHYSICIAN STARTED INJECTING AND AFTER FILLING THE DEAD SPACE OF THE MICROCATHETER, NO OBSIDIO WAS VISUALIZED UNDER FLUOROSCOPY. AT THIS POINT, THERE WAS ROUGHLY ESTIMATED APPROXIMATELY .3CCS OF OBSIDIO LEFT IN THE SYRINGE. IT WAS NOTED THAT THE FLOW OF OBSIDIO WAS SMOOTH WHEN INJECTED; HOWEVER, WHEN IT GOT TO THE END, IT WAS HARDER. IT WAS ATTEMPTED TO INJECT THE REMAINDER OF THE EMBOLIC, BUT IT WAS GETTING SIGNIFICANTLY HARDER TO INJECT. THE MICROCATHETER WAS REMOVED AND REPLACED WITH A NEW ONE TO DO A HAND CONTRAST RUN. ONCE PERFORMED, THERE SEEMED TO BE NO PRODUCT VISUALIZED ANYWHERE IN THE PATIENT. NO EMBOLIZATION HAD TAKEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23595794 ↗
• MalfunctionOct 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT MIGRATION OCCURRED. THE SUBJECT UNDERWENT THE INDEX PROCEDURE ON (B)(6) 2025. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY WITH A VESSEL DIAMETER OF LESS THAN EQUAL 3 MM. PRIOR TO THE EMBOLIZATION WITH OBSIDIO CONFORMABLE EMBOLIC, THE TARGET VESSEL WAS NOT EMBOLIZED WITH ANY OTHER EMBOLIC AGENTS. THE RENAL ARTERY (TARGET VESSEL) WAS EMBOLIZED USING A NON-BOSTON SCIENTIFIC MICRO CATHETER WITH 0.1 ML OF OBSIDIO CONFORMABLE EMBOLIC USING ALIQUOT TECHNIQUE. DURING THE PROCEDURE, THERE WAS NON-TARGET EMBOLIZATION FROM THE TARGET VESSEL (RENAL ARTERY) TO THE SEGMENTAL RENAL ARTERIES. THE TARGET VESSEL OCCLUDED WITHIN THE EXPECTED AREA AFTER EMBOLIZATION WITH OBSIDIO EMBOLIC VIA ANGIOGRAPHY OR DEMONSTRATION OF A CAST OF OBSIDIO OCCLUDING THE ARTERY ON FLUOROSCOPY OR OTHER IMAGE ACQUISITION. POST TREATMENT WITH OBSIDIO EMBOLIC, NO OTHER EMBOLIC AGENT WAS USED. ON (B)(6) 2025, DURING INDEX PROCEDURE, THE OBSIDIO MATERIAL REFLUXED OUT OF THE TARGET VESSEL (RENAL ARTERY) AND EMBOLIZED TO NON-TARGET SEGMENTAL RENAL ARTERIES. NON-TARGET MIGRATION WAS DUE TO REFLUX. THERE WAS NO PHYSICAL ISSUE OF OBSIDIO EMBOLIC, OR DIFFICULTY IN OBSIDIO ADMINISTRATION. THE DEVICE DEFIC

  Patient problems: Embolism/Embolus; Pain

  MAUDE report 23369649 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ANEURYSM AND GASTROINTESTINAL (GI) BLEED OCCURRED, REQUIRING INTERVENTION AND HOSPITALIZATION. OBSIDIO CONFORMABLE EMBOLIC WAS SELECTED FOR USE FOR A GASTRODUODENAL ARTERY (GDA) EMBOLIZATION PROCEDURE. ONE WEEK POST PROCEDURE, ANEURYSM WAS OBSERVED. IT WAS ALSO NOTED THAT 30 DAYS POST PROCEDURE, THE PATIENT PRESENTED WITH A GASTROINTESTINAL (GI) BLEED AND IMAGING SHOWED A PROXIMAL GDA ANEURYSM WITH REVASCULARIZATION OF OBSIDIO. IT WAS REPORTED THAT THE PATIENT HAD A TUMOR GROWING NEXT TO THE GDA, AND IT WAS BELIEVED THAT THIS OCCURRED DUE TO THE TUMOR GROWTH PUSHING INTO THE GDFA AND OBSIDIO. EMBOLIC COILS WERE USED TO OCCLUDE THE ANEURYSM AND BLEED IN THE GDA. THE PATIENT WAS HOSPITALIZED AND FULLY RECOVERED.

  Patient problems: Aneurysm; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23348012 ↗
• InjuryJul 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DEVICE SEPARATION, ILEUM ISCHEMIA, AND PERFORATION OCCURRED. THE SUBJECT WAS ENROLLED IN A CLINICAL STUDY ON (B)(6) 2025 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN THE ILEAL ARTERY WITH A VESSEL DIAMETER OF LESS THAN OR EQUAL TO 3MM. IT WAS NOTED THAT TWO BRANCHES OFF THE SUPERIOR MESENTERIC ARTERY (SMA) WERE IDENTIFIED DURING THE PROCEDURE FOR TARGETING. THESE WERE DESCRIBED AS NOT VERY DISTAL TO THE LEVEL OF VASA RECTA, BUT LIKELY THIRD ORDER VESSELS. PRIOR TO EMBOLIZATION WITH OBSIDIO CONFORMABLE EMBOLIC, THE TARGET VESSEL WAS NOT EMBOLIZED WITH ANY OTHER EMBOLIC AGENTS. THE ILEAL ARTERY (TARGET VESSEL) WAS EMBOLIZED TWICE USING TERUMO PROGREAT MICRO CATHETER WITH 0.2 ML OF OBSIDIO CONFORMABLE EMBOLIC USING NON-ALIQUOT TECHNIQUE. THE TARGET VESSEL WAS OCCLUDED WITHIN THE EXPECTED AREA AFTER EMBOLIZATION WITH OBSIDIO EMBOLIC VIA ANGIOGRAPHY. POST TREATMENT WITH OBSIDIO EMBOLIC, NO OTHER EMBOLIC AGENT WAS USED. ON (B)(6) 2025, TWO DAYS POST INDEX PROCEDURE, THE SUBJECT WAS NOTED WITH TERMINAL ILEUM ISCHEMIA VIA COMPUTED TOMOGRAPHY (CT). THERE WERE ALSO FINDINGS OF PERFORATION AND PERITONITIS. ANOTHER SINGLE-PHASE CT

  Patient problems: Abdominal Pain; Bowel Perforation; Hemorrhage/Blood Loss/Bleeding; Ischemia; Nausea; Peritonitis; Tachycardia

  MAUDE report 22543480 ↗
• InjuryJul 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DEVICE SEPARATION, ILEUM ISCHEMIA, AND PERFORATION OCCURRED. THE SUBJECT WAS ENROLLED IN A CLINICAL STUDY ON (B)(6) 2025 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN THE ILEAL ARTERY WITH A VESSEL DIAMETER OF LESS THAN OR EQUAL TO 3MM. IT WAS NOTED THAT TWO BRANCHES OFF THE SUPERIOR MESENTERIC ARTERY (SMA) WERE IDENTIFIED DURING THE PROCEDURE FOR TARGETING. THESE WERE DESCRIBED AS NOT VERY DISTAL TO THE LEVEL OF VASA RECTA, BUT LIKELY THIRD ORDER VESSELS. PRIOR TO EMBOLIZATION WITH OBSIDIO CONFORMABLE EMBOLIC, THE TARGET VESSEL WAS NOT EMBOLIZED WITH ANY OTHER EMBOLIC AGENTS. THE ILEAL ARTERY (TARGET VESSEL) WAS EMBOLIZED TWICE USING TERUMO PROGREAT MICRO CATHETER WITH 0.2 ML OF OBSIDIO CONFORMABLE EMBOLIC USING NON-ALIQUOT TECHNIQUE. THE TARGET VESSEL WAS OCCLUDED WITHIN THE EXPECTED AREA AFTER EMBOLIZATION WITH OBSIDIO EMBOLIC VIA ANGIOGRAPHY. POST TREATMENT WITH OBSIDIO EMBOLIC, NO OTHER EMBOLIC AGENT WAS USED. ON (B)(6) 2025, TWO DAYS POST INDEX PROCEDURE, THE SUBJECT WAS NOTED WITH TERMINAL ILEUM ISCHEMIA VIA COMPUTED TOMOGRAPHY (CT). THERE WERE ALSO FINDINGS OF PERFORATION AND PERITONITIS. ANOTHER SINGLE-PHASE CT

  Patient problems: Abdominal Pain; Bowel Perforation; Hemorrhage/Blood Loss/Bleeding; Ischemia; Nausea; Peritonitis; Tachycardia

  MAUDE report 22543356 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ABSCESS OCCURRED REQUIRING INTERVENTION. THE SUBJECT UNDERWENT INDEX PROCEDURE ON (B)(6) 2025 AND WAS ENROLLED INTO THE STUDY ON (B)(6) 2025. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY WITH A VESSEL DIAMETER OF 4 MM. THE ANEURYSM WAS NOT BLEEDING. THE LOCATION WAS DISTAL NEAR THE HILUM AND NOT AMENABLE FOR TREATMENT WITH STENT GRAFT. IT HAD TWO INFLOWS MEASURING APPROXIMATELY 4 MM EACH WHICH WERE TARGETED. ACCESS WAS TORTUOUS. PRIOR TO THE EMBOLIZATION WITH OBSIDIO CONFORMABLE EMBOLIC, ONE VESSEL WAS EMBOLIZED WITH THREE NON-BOSTON SCIENTIFIC RETRACTABLE COILS TO BACKSTOP THE EMBOLIZATION IN THE DISTAL PORTION OF TARGET LOCATION. IN THE OTHER VESSEL ONLY OBSIDIO WAS USED AS FLOW WAS FAIRLY STAGNANT. ALIQUOT TECHNIQUE WAS USED FOR BOTH. A TOTAL OF APPROXIMATELY 0.5 ML (HALF OF ONE SYRINGE) OF OBSIDIO WAS USED, IT WAS ESTIMATED ABOUT 0.2 ML IN THE BRANCH WITH COILS AND 0.3 ML IN THE OTHER BRANCH USING A NON-BOSTON SCIENTIFIC MICROCATHETER. IT WAS NOTED THAT SHORT GASTRICS DID NOT FILL IN SUPPLY FOLLOWING EMBOLIZATION AND ONLY ONE SMALL BRANCH WAS LEFT TO SUPPLY THE SPLEEN. POST TREATMENT WITH OBSIDIO EMBOLIC, NO OTHER EMBOLIC AGENT WAS USED. PATIENT W

  Patient problems: Abscess

  MAUDE report 22020562 ↗
• DeathMar 26, 2025Migration; Migration

  IT WAS REPORTED VIA JOURNAL ARTICLE, THAT MIGRATION OCCURRED RESULTING IN PATIENT COMPLICATIONS AND DEATH. OBSIDIO WAS SELECTED FOR AN EMBOLIZATION PROCEDURE OF THE POSTERIOR SUPERIOR PANCREATICODUODENAL ARTERY (PSPDA). THE PATIENT WAS ADMITTED FOR HYPOXEMIC RESPIRATORY FAILURE AND SWEETS SYNDROME, AND THE HOSPITAL COURSE WAS COMPLICATED BY MELENA. THE PATIENTS HEMOGLOBIN DECLINED OVERNIGHT FROM 7.1 TO 5.8 G/DL WITH RECURRENT MELENA AND HEMATEMESIS REQUIRING A BLOOD TRANSFUSION. A COMPUTERIZED TOMOGRAPHY (CT) ANGIOGRAM DEMONSTRATED ACTIVE EXTRAVASATION INTO THE DUODENUM. ANGIOGRAPHY OF THE PSPDA WITH A 2.8 FRENCH NON-BOSTON SCIENTIFIC MICROCATHETER DEMONSTRATED A PSEUDOANEURYSM OF A SMALL BRANCH WHERE SUPER SELECTIVE CATHETERIZATION WAS IMPOSSIBLE. EMBOLIZATION OF THE PSPDA USING OBSIDIO WAS PERFORMED, WITH THE GOAL OF OCCLUDING BRANCHES BEYOND THE REACH OF THE MICROCATHETER. THE ALIQUOT TECHNIQUE WAS UTILIZED TO PRESERVE THE MICROCATHETER FOR LATER USE. WHILE APPLYING A SLOW INJECTION FORCE, 0.2 ML ALIQUOTS OF OBSIDIO WAS FLUSHED WITH A 3 ML SYRINGE AND IOHEXOL, WHICH WAS SURMISED TO BETTER RESEMBLE THE VISCOSITY OF OBSIDIO COMPARED TO NORMAL SALINE. THE EMBOLIC WAS ADMINISTERED U

  Patient problems: Abdominal Pain; Embolism/Embolus; Ischemia; Multiple Organ Dysfunction Syndrome; Necrosis; Pancreatitis; Sepsis

  MAUDE report 21696264 ↗
• InjuryMar 21, 2025Material Separation; Migration; Material Separation; Migration

  IT WAS REPORTED THAT MATERIAL MIGRATION AND SEPARATION OCCURRED RESULTING IN NON TARGET EMBOLIZATION. OBSIDIO WAS SELECTED FOR USE IN A TYPE 2 ENDOLEAK EMBOLIZATION PROCEDURE. THE 4CM ENDOLEAK SAC WAS ACCESSED UNDER COMPUTED TOMOGRAPHY (CT) GUIDANCE USING TWO ACCUSTICK CANNULAS. THE PATIENT WAS BROUGHT TO THE FLUOROSCOPY ROOM AND CONTRAST WAS INJECTED THROUGH A 2.8 NON-BOSTON SCIENTIFIC MICROCATHETER. CONTRAST APPEARED TO STAIN THE SACK BUT DID NOT LEAVE THE ANEURYSMAL SAC. THE MICROCATHETER WAS THEN FLUSHED WITH NORMAL SALINE AND OBSIDIO WAS CONNECTED AND INJECTED INTO THE ANEURYSMAL SAC. THE ENTIRE FIRST SYRINGE WAS INJECTED WITHOUT ISSUE. VISUALIZATION WAS GOOD AND OBSIDIO WAS SEEN FILLING THE SAC. THE SECOND SYRINGE WAS CONNECTED TO THE MICROCATHETER AND OBSIDIO WAS INJECTED TO THE SACK. OBSIDIO WAS INJECTED USING STANDARD DELIVERY. ABOUT HALFWAY THROUGH THE INJECTION, OBSIDIO STARTED TO FILL THE INFERIOR MESENTERIC ARTERY WHICH WAS APPROXIMATELY 3 TO 3 1/2 MILLIMETERS IN DIAMETER. A LARGE COLUMN OF OBSIDIO FILLED THE INFERIOR MESENTERIC ARTERY (IMA) BUT NEVER STOPPED MOVING AND CONTINUED TO FLOW DISTALLY, EVENTUALLY SPLITTING INTO SMALLER PIECES AND EMBEDDING THEMSELVES WITHIN

  Patient problems: Embolism/Embolus

  MAUDE report 21662135 ↗
• InjuryFeb 20, 2025Material Separation; Adverse Event Without Identified Device or Use Problem; Material Separation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MATERIAL SEPARATION OCCURRED RESULTING IN SEQUELA OF THE NON-TARGET EMBOLIZATION. OBSIDIO WAS SELECTED FOR AN EMBOLIZATION PROCEDURE TO TREAT A DISTAL GASTRODUODENAL ARTERY (GDA) BLEED. DURING THE PROCEDURE, 0.2ML OF OBSIDIO WAS DELIVERED USING THE STANDARD DELIVERY TECHNIQUE. AFTER INJECTING A SIGNIFICANT CAST OF OBSIDIO INTO THE GDA MEASURING 2.5MM, A LARGE PIECE OF THE CAST MATERIAL DISLODGED AND EMBOLIZED MORE THAN ONE NON-TARGET DISTAL LIVER VESSELS. A FOLLOW UP COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED. SEQUELA OF THE NON-TARGET EMBOLIZATION TO THE HEPATIC ARTERIES OCCURRED. OBSIDIO CONFORMABLE EMBOLIC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO INTERVENTIONS AND NO PATIENT COMPLICATIONS.

  Patient problems: Embolism/Embolus; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21424962 ↗
• InjuryFeb 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT MIGRATION OCCURRED RESULTING IN NON TARGET EMBOLIZATION REQUIRING ADDITIONAL INTERVENTION. OBSIDIO WAS SELECTED FOR AN EMBOLIZATION PROCEDURE. THE SUBJECT UNDERWENT THE INDEX PROCEDURE ON (B)(6) 2024. THE TARGET LESION WAS LOCATED IN THE GASTRODUODENAL ARTERY WITH A VESSEL DIAMETER OF 4 MM. THE GASTRODUODENAL ARTERY WAS EMBOLIZED USING A NON-BOSTON SCIENTIFIC MICROCATHETER WITH 1 ML OF OBSIDIO CONFORMABLE EMBOLIC USING STANDARD DELIVERY (NON-ALIQUOT) TECHNIQUE. DURING THE PROCEDURE, A SMALL AMOUNT OF OBSIDIO IN THE PROXIMAL GASTRODUODENAL ARTERY MIGRATED IN A RETROGRADE FASHION TO THE HEPATIC ARTERY AND THEN MIGRATED TO SMALL DISTAL HEPATIC ARTERIAL BRANCHES. THERE WAS NO CHANGE IN LIVER PERFUSION OBSERVED DUE TO NON-TARGET EMBOLIZATION TO THE HEPATIC ARTERIES. POST EMBOLIZATION WITH OBSIDIO, PENUMBRA COIL WAS USED IN THE PROXIMAL GASTRODUODENAL ARTERY TO COMPLETE THE EMBOLIZATION. THE TARGET VESSEL WAS OCCLUDED WITHIN THE EXPECTED AREA AFTER EMBOLIZATION WITH OBSIDIO EMBOLIC VIA ANGIOGRAPHY. ON (B)(6) 2025, THE SUBJECT WAS DISCHARGED. IT WAS FURTHER REPORTED THAT PRIOR AND POST EMBOLIZATION WITH OBSIDIO COMFORMABLE EMBOLIC, THE TARGET VESSEL WAS EMBOLIZED USIN

  Patient problems: Embolism/Embolus

  MAUDE report 21365457 ↗
• InjuryFeb 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DISLODGEMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. OBSIDIO WAS SELECTED FOR AN EMBOLIZATION PROCEDURE. THE OBSIDIO WAS DELIVERED THROUGH A COIL PACK FROM A PREVIOUS CASE THAT HAD RECANALIZED. THE STANDARD DELIVERY OF OBSIDIO WENT SMOOTHLY. DURING AN ATTEMPT TO REMOVE THE MICROCATHETER, BY PULLING IT BACK THROUGH THE COIL PACK POST EMBOLIZATION, THE MICROCATHETER MAY HAVE BEEN KINKED CAUSING A PORTION OF THE OBSIDIO MATERIAL TO BECOME LOOSE FROM THE MICROCATHETER AND GO DISTAL AS THE MICROCATHETER WAS PULLED OUT AT THE ARTERIAL BRANCH. THE DISLODGED EMBOLIC MATERIAL WENT DISTAL CAUSING PERFUSION OF VESSELS THAT SUPPLY THE HAND/FINGERS. THE PHYSICIANS ATTEMPTED TO SUCK OUT THE SHEERED MATERIAL, USING ASPIRATION, WHICH CAUSED IT TO GO EVEN MORE DISTAL AND FURTHER SHEER. IMMEDIATELY FOLLOWING THE EMBOLIZATION PROCEDURE, THE PATIENT EXPERIENCED PAIN AND DISCOMFORT. AN UNKNOWN INTERVENTION WAS USED TO TREAT THE PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT HAS SINCE RECOVERED AND WAS DISCHARGED.

  Patient problems: Discomfort; Embolism/Embolus; Numbness; Pain

  MAUDE report 21322195 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ABSCESS OCCURRED. OBSIDIO WAS USED IN AN EMBOLIZATION PROCEDURE TO TREAT A BLEED IN THE RETROPERITONEAL SPACE. THE STANDARD DELIVERY METHOD WAS USED TO DELIVER THE OBSIDIO TO THE TARGET LOCATION. AN INFECTION WAS NOTED IN A VESSEL IN THE RETROPERITONEAL SPACE, RESULTING IN AN ABSCESS.

  Patient problems: Abscess

  MAUDE report 21313744 ↗

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