OBSIDIO™ M0013972101010Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00191506043124), received between Nov 20, 2023 and Feb 10, 2026 — classified as 21 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (16 reports).

1 FDA recall record name this device's 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, 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 16, 2026.

Recalls naming this device

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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, 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 ↗
• 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 ↗
• 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 ↗
• InjuryDec 17, 2024Material Separation; Activation, Positioning or Separation Problem; Infusion or Flow Problem; Material Separation; Activation, Positioning or Separation Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT MATERIAL SEPARATION OCCURRED RESULTING IN EMBOLIZATION OF AN UNINTENDED LOCATION. OBSIDIO WAS SELECTED FOR SEVERAL BLEEDS AND KIDNEY EMBOLIZATION PROCEDURES. IT WAS NOTED THAT WHEN USING OBSIDIO IN SMALL 1 TO 2MM SIZED VESSELS, IT IS UNPREDICTABLE AND DOES NOT FORM AS IT SHOULD. PROPER INJECTION TECHNIQUES WERE APPLIED. THE SPEED OF THE INJECTIONS WAS AVERAGE. THE OBSIDIO FLOWED FORWARD AND FLEXED. FRAGMENTATION OF OBSIDIO OCCURRED RESULTING IN EMBOLIZATION OF AN UNINTENDED LOCATION. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Embolism/Embolus

  MAUDE report 20958609 ↗
• InjuryDec 17, 2024Material Separation; Activation, Positioning or Separation Problem; Infusion or Flow Problem; Material Separation; Activation, Positioning or Separation Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT MATERIAL SEPARATION OCCURRED RESULTING IN EMBOLIZATION OF AN UNINTENDED LOCATION. OBSIDIO WAS SELECTED FOR SEVERAL BLEEDS AND KIDNEY EMBOLIZATION PROCEDURES. IT WAS NOTED THAT WHEN USING OBSIDIO IN SMALL 1 TO 2MM SIZED VESSELS, IT IS UNPREDICTABLE AND DOES NOT FORM AS IT SHOULD. PROPER INJECTION TECHNIQUES WERE APPLIED. THE SPEED OF THE INJECTIONS WAS AVERAGE. THE OBSIDIO FLOWED FORWARD AND FLEXED. FRAGMENTATION OF OBSIDIO OCCURRED RESULTING IN EMBOLIZATION OF AN UNINTENDED LOCATION. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Embolism/Embolus

  MAUDE report 20958599 ↗
• InjuryDec 17, 2024Material Separation; Activation, Positioning or Separation Problem; Infusion or Flow Problem; Material Separation; Activation, Positioning or Separation Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT MATERIAL SEPARATION OCCURRED RESULTING IN EMBOLIZATION OF AN UNINTENDED LOCATION. OBSIDIO WAS SELECTED FOR SEVERAL BLEEDS AND KIDNEY EMBOLIZATION PROCEDURES. IT WAS NOTED THAT WHEN USING OBSIDIO IN SMALL 1 TO 2MM SIZED VESSELS, IT IS UNPREDICTABLE AND DOES NOT FORM AS IT SHOULD. PROPER INJECTION TECHNIQUES WERE APPLIED. THE SPEED OF THE INJECTIONS WAS AVERAGE. THE OBSIDIO FLOWED FORWARD AND FLEXED. FRAGMENTATION OF OBSIDIO OCCURRED RESULTING IN EMBOLIZATION OF AN UNINTENDED LOCATION. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Embolism/Embolus

  MAUDE report 20958598 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ISCHEMIA AND PERFORATION REQUIRING ADDITIONAL INTERVENTION. OBSIDIO WAS SELECTED FOR AN EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA). THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR RECTAL BLEEDING ONE DAY PRIOR TO THIS EVENT. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) OF THE ABDOMEN AND PELVIS DEMONSTRATED DIVERTICULOSIS OF THE DESCENDING AND SIGMOID COLON WITH ACTIVE BLEEDING IN THE DISTAL DESCENDING COLON. THE PATIENTS HEMOGLOBIN QUICKLY DOWN-TRENDED OVER THE PRECEDING 12 HOURS. THE PATIENT BECAME ACUTELY SYMPTOMATIC AFTER A BLOODY BOWEL MOVEMENT, WITH SYSTOLIC BLOOD PRESSURES IN THE 60S. THE DECISION WAS MADE TO PROCEED IMMEDIATELY TO ANGIOGRAPHY GIVEN THE PATIENTS APPARENT HEMODYNAMIC INSTABILITY AND ONGOING ACTIVE HEMORRHAGE ON (B)(6) 2024. THE PATIENT RESPONDED WELL TO INITIAL RESUSCITATION EFFORTS. ARTERIOGRAPHY VIA THE INFERIOR MESENTERIC ARTERY (IMA) WAS PERFORMED WHICH FAILED TO DEMONSTRATE ANGIOGRAPHIC EVIDENCE OF BLEEDING. A 2.4 FR PROGREAT MICROCATHETER WAS PLACED COAXIALLY INTO A 3RD AND SUBSEQUENTLY 4TH ORDER BRANCH OF THE IMA CORRESPONDING TO THE BLEEDING BRANCH ON THE CTA (BOTH BRANCHES MEASURED < 2MM IN DIAME

  Patient problems: Abdominal Pain; Ischemia; Perforation; Unspecified Tissue Injury

  MAUDE report 19537356 ↗
• InjuryMay 24, 2024Material Separation; Activation, Positioning or Separation Problem; Material Separation; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT INSUFFICIENT FORMATION AND FRAGMENTATION OF OBSIDIO OCCURRED REQUIRING ADDITIONAL INTERVENTION. OBSIDIO WAS SELECTED FOR A TRANSCATHETER EMBOLIZATION PROCEDURE OF THE LEFT DEEP CIRCUMFLEX ILIAC ARTERY. THE PATIENT HAD A HISTORY OF A 10 CM RUPTURED LEFT COMMON ILIAC ARTERY ANEURYSM AND UNDERWENT OPEN REPAIR. PRIOR TO THE DATE OF THE CURRENT PROCEDURE (B)(6) 2024), THE PATIENT UNDERWENT RIGHT INTERNAL ILIAC ARTERY EMBOLIZATION AND PERCUTANEOUS EMBOLIZATION OF A SIGNIFICANT ENDOLEAK RELATED TO THE LEFT ILIAC ARTERY ANEURYSM. DUE TO A PERSISTENT TYPE II ENDOLEAK, THE PHYSICIAN PLANNED TRANSCATHETER EMBOLIZATION OF THE LEFT DEEP CIRCUMFLEX ILIAC ARTERY VIA A RIGHT COMMON FEMORAL ARTERY APPROACH. A MICROCATHETER WAS PLACED COAXIALLY GREATER THAN 10 CM INTO THE LEFT DEEP CIRCUMFLEX ILIAC ARTERY. THE VESSEL SIZE WAS APPROXIMATELY 2.5MM. ARTERIOGRAPHY REVEALED COMMUNICATION BETWEEN THE ENDOLEAK CAVITY AND THE LEFT ILIAC VEIN. FOLLOWING ARTERIOGRAPHY, EMBOLIZATION WAS PERFORMED WITH ONE SYRINGE OF OBSIDIO USING STANDARD TECHNIQUE. FLUOROSCOPY REVEALED NO OBSIDIO IN THE TARGET VESSEL. SUBSEQUENT EMBOLIZATION WAS PERFORMED USING 2 X 3MM COILS. COMPUTERIZED TOMOGRAPHY (CT)

  Patient problems: Embolism/Embolus

  MAUDE report 19393618 ↗
• MalfunctionMay 24, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT MATERIAL SEPARATION OCCURRED. OBSIDIO WAS SELECTED FOR USE IN THE SPLENIC ARTERY. DURING THE PROCEDURE, OBSIDIO WAS DELIVERED USING THE STANDARD TECHNIQUE. OBSIDIO BEGAN TO FILL THE NEST OF THE 8X40 NON-BOSTON SCIENTIFIC COIL AND PROCEEDED TO FILL THE VESSEL PROXIMAL TO THE COIL. THE NEXT MORNING, A COMPUTERIZED TOMOGRAPHY (CT) SCAN IDENTIFIED FRAGMENTS OF OBSIDIO THAT TRAVELED BEYOND THE COIL AND DISTAL INTO THE SPLEEN. NO ADDITIONAL ACTIONS WERE REQUIRED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: Embolism/Embolus

  MAUDE report 19393454 ↗
• InjuryFeb 28, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT EMBOLISM OCCURRED. OBSIDIO WAS SELECTED FOR USE IN A LEFT GASTRIC EMBOLIZATION PROCEDURE. THE VESSEL SIZE WAS 3MM OR LESS. APPROXIMATELY .3ML OF THE OBSIDIO MATERIAL WAS INJECTED USING A 2.8 FRENCH HIGH FLO MICROCATHETER. APPROXIMATELY .05ML OF THE OBSIDIO MATERIAL WENT DISTAL AS INTENDED. OCCLUSION WAS REACHED VERY QUICKLY. ON THE SAME DAY, OBSIDIO WAS NOTED TO HAVE GONE TO THE STOMACH. NECROSIS OCCURRED AND THE PATIENT WAS SENT TO THE OPERATING ROOM (OR) TO RESECT A SMALL PORTION OF THE STOMACH THAT HAD THE NECROSIS. THE PATIENT FULLY RECOVERED. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A HISTORY OF REFRACTORY UPPER GASTROINTESTINAL BLEEDING OVER AT LEAST 8 MONTHS. THE PATIENT WAS IN AND OUT OF THE HOSPITAL FOR THESE EVENTS AND UNDERWENT MULTIPLE PRIOR ENDOSCOPY PROCEDURES WITH CLIPPINGS AND EMPIRIC GASTRODUODENAL ARTERY EMBOLIZATION WITH COILS. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL WITH PERSISTENT BLEEDING. ENDOSCOPY WAS PERFORMED AND DEMONSTRATED ULCERATIONS THROUGHOUT THE GASTRIC FUNDUS. THE PATIENT UNDERWENT ANGIOGRAPHY WHICH DID NOT DEMONSTRATE ACTIVE BLEEDING OR OTHER ANGIOGRAPHIC EVIDENCE OF A SOURCE OF BLEEDING. THE GASTRODUODENAL ARTERY WAS

  Patient problems: Embolism/Embolus; Ischemia; Necrosis; Pain; Unspecified Tissue Injury

  MAUDE report 18799209 ↗
• InjuryFeb 19, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT NON TARGET EMBOLIZATION OCCURRED. OBSIDIO WAS SELECTED FOR USE IN AN OVARIAN EMBOLIZATION PROCEDURE. THE SIZE OF THE LEFT GONADAL VEIN WAS APPROXIMATELY 6-7MM IN DIAMETER. ONE 6X20 EMBOLD COIL AND TWO 8X20 EMBOLD COILS WERE IMPLANTED. THE CATHETER CONTAINING THE OBSIDIO MATERIAL WAS PLACED APPROXIMATELY 1 CM PROXIMAL TO THE EMBOLD COILS AND 2.5CC OF OBSIDIO WAS SUCCESSFULLY IMPLANTED. IT WAS NOTED THAT 2.0CC OF OBSIDIO WAS DELIVERED USING A NON-ALIQUOT TECHNIQUE AND .5CC OF OBSIDIO WAS DELIVERED USING THE ALIQUOT TECHNIQUE. UPON REVIEW AFTER CASE FOLLOW-UP, NON TARGET EMBOLIZATION WAS OBSERVED AT THE PROXIMAL BIFURCATION, 2-3CM BELOW THE LEFT RENAL VEIN. THE PATIENT STATUS WAS STABLE POST PROCEDURE.

  Patient problems: Embolism/Embolus

  MAUDE report 18735699 ↗
• InjuryJan 29, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT PATIENT COMPLICATIONS OCCURRED REQUIRING ADDITIONAL INTERVENTION. OBSIDIO WAS USED FOR A RECTAL ARTERY EMBOLIZATION OF ACUTE RECTAL BLEEDING. THE PATIENT WAS ADMITTED WITH AN ACUTE MASSIVE LOWER GASTROINTESTINAL (GI) BLEED THAT MEASURED -2MM. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) REVEALED AN ACTIVE RECTAL ARTERY BRANCH BLEEDING WITH CONTRAST EXTRAVASATION FROM THE RIGHT SIDE OF THE RECTUM. AN ANGIOGRAM REVEALED A SIMILAR FINDING, AND THE PATIENT UNDERWENT SELECTIVE RECTAL ARTERY BRANCH EMBOLIZATION WITH OBSIDIO. A 2.4 FR NON-BOSTON SCIENTIFIC MICROCATHETER WAS USED WITH 0.1 ML OF OBSIDIO USING THE ALIQUOT TECHNIQUE. THE PHYSICIAN WAS PLEASED WITH THE DELIVERY OF OBSIDIO WITH CESSATION OF BLEEDING. THE PATIENT HAD DECREASE IN HEMOGLOBIN AND MINIMAL RECTAL BLEEDING AND UNDERWENT A COMPUTED TOMOGRAPHY (CT) 2 DAYS AFTER THE INITIAL EMBOLIZATION PROCEDURE. THE CT REVEALED A RENT IN THE RECTAL WALL AT THE SITE OF THE INITIAL BLEEDING AND EMBOLIZATION. OBSIDIO WAS NOTED TO BE 2CM MORE DISTAL IN THE ARTERY AND RECTAL WALL COMPARED WITH THE POST PROCEDURE ANGIOGRAM/FLUOROSCOPIC IMAGES, WHICH LED TO ISCHEMIA. THE PATIENT UNDERWENT A COLONOSCOPY WHICH DEMONSTRATED FOCAL P

  Patient problems: Bowel Perforation; Embolism/Embolus; Fecal Incontinence; Ischemia; Pain

  MAUDE report 18602410 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLICATIONS OCCURRED REQUIRING HOSPITALIZATION AND PATIENT EXPIRED. OBSIDIO WAS SELECTED FOR A HEMORRHOIDAL ARTERY EMBOLIZATION OF THE BILATERAL SUPERIOR AND MIDDLE RECTAL ARTERIES IN ALL 4 BRANCHES. THE SIZE OF THE VESSELS WERE LESS THAN 2MM. THE PHYSICIAN DESCRIBED VARIABLE FEEL OF DELIVERING OBSIDIO IN EACH OF THE ARTERIES USING THE ALIQUOT TECHNIQUE. THE PHYSICIAN REPORTED A TOTAL OBSIDIO VOLUME FOR ENTIRE PROCEDURE OF AROUND 0.25 ML. THE PHYSICIAN DID NOT NOTICE ANY EVIDENCE OF FRAGMENTATION ON FLUOROSCOPY. THE PATIENT WAS DISCHARGED HOME POST PROCEDURE. THE PATIENT WAS READMITTED TO THE HOSPITAL DUE TO URINARY RETENTION. LEUKOCYTOSIS WAS NOTED WHICH FELT SECONDARY TO THE EXPECTED POST-EMBOLIZATION SYNDROME. THE PATIENT HAD NO SIGNIFICANT RECTAL PAIN. A PROCTOSCOPY WAS PERFORMED AT APPROXIMATELY 3 WEEKS INTO THE ADMISSION. THE PATIENT WAS FOUND TO HAVE APPROXIMATELY 25 CM LONG OF CIRCUMFERENTIAL NECROSIS OF RECTUM CONSISTENT WITH ISCHEMIC CHANGES. PAIN AT THIS POINT WAS IMPROVED AND THE PATIENT WAS TOLERATING A FULL DIET. RESCOPING WAS PERFORMED 4-5 DAYS LATER AND ISCHEMIC CHANGES APPEARED IMPROVED AND THE PATIENT WAS DISCHARGED HOME. ONE WEEK LA

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bowel Perforation; Ischemia; Necrosis; Pain; Urinary Retention

  MAUDE report 18487080 ↗
• InjuryJan 10, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A VISUALIZATION ISSUE OCCURRED RESULTING IN A NON-TARGET EMBOLISM. OBSIDIO WAS SELECTED FOR USE TO TREAT A GASTROINTESTINAL (GI) BLEED IN THE SUPERIOR MESENTERIC ARTERY (SMA). THE VESSEL SIZE WAS .06MM. DURING THE PROCEDURE, A TOTAL OF 0.15ML OF OBSIDIO WAS INJECTED THROUGH THE .021 TRUSELECT MICROCATHETER, USING THE ALIQUOT METHOD. THE PHYSICIAN WAS UNABLE TO SEE THE OBSIDIO EXIT THE CATHETER, RESULTING IN A SERIES OF SMALL VESSELS BEING EMBOLIZED INSTEAD OF THE TARGETED SINGLE SMALL VESSEL. THE PATIENT EXPERIENCED SOME MINOR PAIN A FEW DAYS POST PROCEDURE, WITH POSSIBLE MINOR NECROSIS. THIS CONDITION RESOLVED RELATIVELY QUICKLY, AND THE PATIENT FULLY RECOVERED AFTER A HOSPITAL STAY.

  Patient problems: Embolism/Embolus; Necrosis; Pain

  MAUDE report 18487076 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED COMPLICATIONS AND WAS HOSPITALIZED. OBSIDIO WAS SELECTED FOR HEMORRHOIDAL ARTERY EMBOLIZATION OF THE BILATERAL SUPERIOR AND MIDDLE RECTAL ARTERIES IN ALL 4-5 BRANCHES. THE SIZE OF THE VESSELS WERE LESS THAN 3MM. THE PHYSICIAN DESCRIBED VARIABLE FEEL OF DELIVERING OBSIDIO IN EACH OF THE ARTERIES USING THE ALIQUOT TECHNIQUE. THE PATIENT EXPERIENCED A MODERATE AMOUNT OF PAIN ONE DAY POST PROCEDURE. TWO DAYS POST PROCEDURE, THE PATIENT EXPERIENCED IMPROVED PAIN AND THE PATIENT RETURNED TO WORK. FOUR WEEKS POST PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH INCREASED RECTAL PAIN AND MINIMAL BLEEDING. THE PATIENT DEVELOPED RECTAL ISCHEMIA IN THE SAME LOCATION THE OBSIDIO WAS PLACED. THE PATIENT UNDERWENT PROCTOSCOPY WHICH REVEALED FOCAL ULCERATION IN THE RECTUM WITHOUT PERFORATION. OBSIDIO WAS ALSO OBSERVED PROXIMAL TO THE TARGET LESION. ENDOSCOPIC CLIPPING WAS PERFORMED. THE PATIENT STATUS IS STABLE. THE PATIENT WAS DISCHARGED THE NEXT DAY AND HAS RECOVERED.

  Patient problems: Embolism/Embolus; Ischemia; Pain; Ulcer

  MAUDE report 18487071 ↗