EMBOTRAP ET309522Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10886704082866), received between Mar 29, 2022 and Aug 16, 2026 — classified as 3 deaths, 21 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• InjuryAug 16, 2026Adverse Event Without Identified Device or Use Problem

  The healthcare professional reported that during a mechanical thrombectomy procedure targeting an occlusion in the middle cerebral artery (MCA) at the M1-M2 bifurcation, the devices were used in accordance with their respective instructions for use (IFUs). It was reported that initially, a 132cm Cereglide 71 Intermediate Catheter (NIC71132U / lot# unknown) was used; however, distal embolism was observed. As a result, the procedure was continued using a combination of the Cereglide 71 intermediate catheter and a 144 cm Cereglide 42 Catheter (NIC42144C / lot# unknown). A 5mm x 22mm EmboTrap III Revascularization device (ET309522 / lot# unknown) was subsequently used to treat the residual thrombus. The thrombus was successfully retrieved, but post-operative imaging confirmed the presence of a hemorrhage. No additional intervention was performed. The patient is reported to be currently showing signs of recovery without additional intervention. It was not known whether a continuous flush was maintained during the procedure.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 50264946 ↗
• MalfunctionMay 15, 2026Material Separation

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS A MECHANICAL THROMBECTOMY OF MIDDLE CEREBRAL ARTERY, SEGMENT M1 TO TREAT ACUTE ISCHEMIC STROKE AN EMBOTRAP III 5 MM X 22 MM (PRODUCT CODE: ET309522, LOT NUMBER: ET309522) WAS USED. RECANALIZATION WAS ACHIEVED WITHOUT PROBLEMS DURING THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. HOWEVER, CONFIRMATION WHETHER THE USED STENT HAD ANY DAMAGE OR SCRATCHES WAS REQUESTED. THE PHYSICIAN REQUESTED INVESTIGATION OF THE STENT AFTER USE, ALTHOUGH THE PROCEDURE ITSELF WAS COMPLETED WITHOUT ANY PRODUCT-RELATED ISSUES. THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICES WERE OPTIMO 9FR GUIDING CATHETER, CHIKAI NEXUS GUIDEWIRE, PHENOM MICROCATHETER. ADDITIONAL EVENT INFORMATION RECEIVED ON (B)(6) 2026 INDICATED THAT THERE WAS NO IMPACT ON THE PATIENT; HOWEVER, DURING THE FINAL ANGIOGRAPHY AT THE END OF THE PROCEDURE, A SHADOW LIKE FINDING WAS OBSERVED. ALTHOUGH IT WAS NOT LARGE ENOUGH TO BE DEFINITIVELY IDENTIFIED AS A FOREIGN BODY, THE PHYSICIAN SUSPECTED THAT IT MIGHT REPRESENT A FRAGMENT FROM ONE OF THE DEVICES USED DURING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25187043 ↗
• DeathFeb 17, 2026Lack of Effect

  IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT AN EMBOTRAP III 5 MM X 22 MM (ET309522/ LOT # UNKNOWN), A GEOMETRIC CLOT EXTRACTOR 4.5 X (GCE4528/ 25J188AV), AND A CEREGLIDE57 INTERMEDIATE CATHETER (PRODUCT CODE/ LOT # UNKNOWN) WERE USED FOR A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, A TOTAL OF FIVE PASSES WERE PERFORMED BUT RECANALIZATION WAS NOT ACHIEVED, AND THE PROCEDURE WAS CANCELLED WITH TICI 0 (COMPLETE OCCLUSION). POSTOPERATIVE CT SHOWED A FAINT HEMORRHAGE, AND THE PATIENT WAS KEPT FOR INPATIENT OBSERVATION. APPROXIMATELY SEVEN DAYS AFTER THE PROCEDURE THE HEMORRHAGE EXPANDED; NEUROSURGERY PHYSICIAN PERFORMED EXTERNAL DECOMPRESSION THERAPY. THE PATIENT ULTIMATELY PASSED AWAY DUE TO SYMPTOMATIC INTRACRANIAL HEMORRHAGE. THE PHYSICIAN JUDGED THAT THERE WAS A CAUSAL RELATIONSHIP BETWEEN THE PATIENT¿S OUTCOME AND THE DEVICES USED. THE PHYSICIAN FURTHER COMMENTED THAT ¿ALTHOUGH THE POSTOPERATIVE BLEEDING WAS MINOR, THIS IS A RARE CASE THAT WORSENED AFTER SURGERY. THE REASON FOR THE DETERIORATION IS UNKNOWN. EMBOTRAP AND NIMBUS WERE EACH USED, BUT THERE WAS NO VESSEL STRAIGHTENING OR RESISTANCE DURING TRACTION. IT IS POSSIBLE THAT PERFORMING FIVE PASSES WITH STENT RETRIEVER

  Patient problems: Intracranial Hemorrhage

  MAUDE report 24364882 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA PERSONAL INTERACTION, THAT AN EMBOTRAP III 5 MM X 22 MM (ET309522/ LOT # UNKNOWN) WAS USED FOR A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION AT THE DISTAL M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE EMBOTRAP III DEVICE WAS USED TO TREAT A DISTAL M2 MIDDLE CEREBRAL ARTERY OCCLUSION. AN INITIAL ATTEMPT TO TREAT A MIDDLE CEREBRAL ARTERY (M1) OCCLUSION WAS MADE USING CEREGLIDE71 WITH THE ADAPT TECHNIQUE (A DIRECT ASPIRATION, FIRST PASS TECHNIQUE). ANGIOGRAPHY DEMONSTRATED OCCLUSIONS IN M2 PROXIMAL AND M2 DISTAL. THE THROMBUS IN M2 PROXIMAL WAS RETRIEVED USING NIMBUS. FOR THE THROMBUS IN M2 DISTAL, BECAUSE THE VESSEL DIAMETER WAS SMALL (APPROXIMATELY 1.3 MM), THE EMBOTRAP III WAS USED WITH ONLY ONE SEGMENT DEPLOYED; BLEEDING WAS OBSERVED AT THAT TIME. FINAL ANGIOGRAPHY WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN COMMENTED THAT THE EMBOTRAP IS INDICATED FOR VESSELS = 1.5 MM AND THAT USING IT IN A 1.3 MM VESSEL MIGHT HAVE CAUSED THE BLEEDING. THE PATIENT¿S CONDITION IS UNKNOWN. CONTINUOUS FLUSH WAS UNKNOWN. THE LESION WAS MIDDLE CEREBRAL ARTERY M2 DISTAL. ANOTHER CONCOMITANT DEVICES WERE TRAK MICROCATHETER (STRYKER) AND CEREGLIDE

  Patient problems: Intracranial Hemorrhage

  MAUDE report 23992285 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT A CEREBRAL INFARCTION, TARGETING AN OCCLUSION IN THE M1-M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA), THE DEVICES WERE USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFUS). THE FIRST PASS WAS MADE VIA A DIRECT FIRST PASS TECHNIQUE (ADAPT) USING THE 132CM CEREGLIDE 71 INTERMEDIATE CATHETER (NIC71132U / LOT# UNKNOWN), BUT DUE TO THE LARGE AMOUNT OF THROMBUS NOT ALL OF THE CLOT COULD BE RETRIEVED. FOR THE SECOND PASS, A 5MM X 22MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309522 / LOT# UNKNOWN) WAS USED. IT WAS REPORTED THAT AFTER THE EMBOTRAP III DEVICE WAS DEPLOYED, RECANALIZATION WAS ACHIEVED, BUT HEMORRHAGE WAS OBSERVED. HEMOSTASIS WAS ACHIEVED USING AN 8FR OPTIMO¿ BALLOON GUIDE CATHETER ((B)(6) MEDICAL) AND THE PROCEDURE WAS REPORTED TO BE COMPLETE. CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. THE PATIENT¿S CONDITION POST-PROCEDURE IS CURRENTLY UNKNOWN. ON 31-JUL-2025, LIMITED ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, IMAGES AND ANGIOGRAPHS ARE NOT AVAILABLE FOR REVIEW. THE HEMORRHAGE WAS TREATED VIA THE INFLATION OF THE OPTIMO BALLOON CATHETER. THE INFORMATI

  Patient problems: Intracranial Hemorrhage

  MAUDE report 22778293 ↗
• MalfunctionApr 21, 2025Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  AS REPORTED BY THE FIELD, DURING A MECHANICAL THROMBECTOMY, AN EMBOTRAP III 5 MM X 22 MM THROMBUS RETRIEVER (ET307522, 24K156AV) BECAME IMPEDED IN THE INTRODUCER AND COULD NOT BE PUSHED INTO THE MICROCATHETER (MC). THE PHYSICIAN ONLY RETRACTED THE STENT ALONE AND SWITCHED A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 02-APR-2025 INDICATED THAT THE INSERTION TOOL WAS SECURELY PLACED IN THE HUB OF THE MICROCATHETER PRIOR TO ATTEMPTING TO ADVANCE THE EMBOTRAP. ONE PASS HAD BEEN ATTEMPTED TO RETRIEVE THE CLOT. THERE WAS NO PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872674 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT AN EMBOTRAP III 5 MM X 22 MM (ET309522/ LOT # UNKNOWN) WAS USED FOR A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION AT THE RIGHT INTERNAL CAROTID ARTERY (ICA) AND M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). DURING THE PROCEDURE, THE EMBOTRAP III WAS USED FOR THE THIRD PASS, WHICH RESULTED IN RECANALIZATION AND AN MTICI SCORE OF 2A. HOWEVER, POST-PROCEDURE COMPUTED TOMOGRAPHY (CT) IMAGING SHOWED SUBARACHNOID HEMORRHAGE, ¿LIKELY DUE TO A PULL-OUT INJURY.¿ POST-PROCEDURE CHANGES IN THE PATIENT WERE REPORTED AS ¿NEUROLOGICAL SYMPTOMS AND APHASIA REMAINED, BUT PARALYSIS IMPROVED.¿ THE PROCEDURE TIME WAS TWO HOURS AND THIRTY MINUTES. ¿THE VASCULAR WAS SEVERELY TORTUOUS AND TANDEM OCCLUSION OF ICA AND M2, WHICH MADE THE PROCEDURE VERY DIFFICULT.¿ OTHER CONCOMITANT DEVICES WERE A PHENOM MICROCATHETER (MEDTRONIC) AND A 9FR OPTIMO BALLOON CATHETER (TOKAI). THE EVENT WAS REPORTED AS SUCH, ¿THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF RIGHT INTERNAL CAROTID ARTERY AND MIDDLE CEREBRAL ARTERY M2. THE RIGHT ICA WAS NOT DELINEATED DURING PREOPERATIVE EVALUATION, MECHANICAL THROMBECTOMY WAS PERFORMED WITHOUT T-PA ADMINISTRATION. A 9F

  Patient problems: Intracranial Hemorrhage

  MAUDE report 20011474 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT AN EMBOTRAP III 5 MM X 22 MM (ET309522/LOT # UNKNOWN) WAS USED FOR A MECHANICAL THROMBECTOMY TO TREAT AN OCCLUSION AT THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). DURING THE PROCEDURE, THE USER REPORTED BLEEDING WAS FOUND AFTER DEVICE WAS DEPLOYED AND PULLED PROXIMALLY. THE EVENT WAS REPORTED AS SUCH, ¿THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF MIDDLE CEREBRAL ARTERY M2 FOR CEREBRAL INFARCTION. DURING THROMBUS RETRIEVAL, AS THE EMBOTRAP III WAS DEPLOYED AT PERIPHERAL AND PULLED PROXIMALLY, BLEEDING WAS FOUND. POST-PROCEDURE CHANGES IN THE PATIENT: UNKNOWN. CONTINUOUS FLUSH WAS DONE. THE LESION WAS MIDDLE CEREBRAL ARTERY M2. OTHER CONCOMITANT DEVICE IS CAT6 INTERMEDIATE CATHETER (PENUMBRA).¿ NO FURTHER INFORMATION WAS MADE AVAILABLE AT THE TIME OF THIS REVIEW.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 19259498 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT AN EMBOTRAP III 5 MM X 22 MM (ET309522/ 23H184AV) WAS USED FOR A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION AT THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) IN A PATIENT EXPERIENCING AN ACUTE ISCHEMIC STROKE. DURING THE PROCEDURE, THE USER REPORTED THE THROMBUS COULD NOT BE RETRIEVED AND ¿BLEEDING¿ WAS FOUND. THE EVENT WAS REPORTED AS SUCH, ¿THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF MIDDLE CEREBRAL ARTERY M1 FOR ACUTE ISCHEMIC STROKE. AFTER PLACING MICROCATHETER, DEPLOYED THE EMBOTRAP III AT THE LESION. PERFORMED SEVERAL PASS BUT THE THROMBUS COULD NOT BE RETRIEVED. THEN FOUND THE BLEEDING. THE PHYSICIAN COMMENTED THAT COULD NOT DETERMINE IF THERE WAS A CAUSAL RELATIONSHIP BETWEEN THE BLEEDING AND THE DEVICE.¿ THE IMPACT TO THE PATIENT WAS UNKNOWN. CONTINUOUS FLUSH WAS DONE. THE LESION WAS MIDDLE CEREBRAL ARTERY M1. OTHER CONCOMITANT DEVICES WERE UNKNOWN. NO FURTHER INFORMATION WAS MADE AVAILABLE AT THE TIME OF THIS REVIEW.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 18941543 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE EXCELLENT STUDY, THE 66-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF ATRIAL FIBRILLATION AND HYPERLIPIDEMIA, PRESENTED WITH A WITNESSED STROKE ON (B)(6) 2023 AT 21:30 HOUR. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2023 AT 22:53 HOUR, WHERE MAGNETIC RESONANCE IMAGING (MRI) IMAGING CONFIRMED AN ISCHEMIC STROKE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS CARDIOEMBOLIC. THE PATIENT¿S BASELINE NIH STROKE SCALE (NIHSS) SCORE WAS 12 AND A MODIFIED RANKIN SCALE (MRS) SCORE WAS 0 ¿ NO SYMPTOMS. THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY ON (B)(6) 2023 USING A 5MM X 22MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309522 / 23D144AV) THAT TARGETED AN OCCLUSION IN THE LEFT M3 OF THE MIDDLE CEREBRAL ARTERY (MCA). THE PRE-PASS MODIFIED TREATMENT IN CEREBRAL INFARCTION (MTICI) SCORE WAS 0. THE FIRST PASS WAS MADE WITH THE EMBOTRAP III VIA A TREVO TRAK 21 MICROCATHETER (STRYKER) RESULTED IN AN MTICI SCORE OF 2C WITH CLOT RETRIEVAL. IT WAS NOT KNOWN IF THERE WAS ANY INTRA-OPERATIVE DEVICE DEFICIENCY WITH STUDY DEVICE DURING THE PROCEDURE. THE PATIENT¿S 24-HOUR POST-PROC

  Patient problems: Intracranial Hemorrhage; Ischemia Stroke

  MAUDE report 18259862 ↗
• InjuryOct 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE EXCELLENT STUDY, THE 74-YEAR-OLD MALE PATIENT WITH A HISTORY OF HYPERTENSION AND PREVIOUS SMOKING (QUIT DATE ON (B)(6) 2023) PRESENTED WITH A WITNESSED STROKE ON (B)(6) 2023 AT 05:30 HOUR. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON THE SAME DAY AT 07:53 HOUR. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿OTHER ETIOLOGIES- TROUSSEAU SYNDROME.¿ THE PATIENT¿S BASELINE NIH STROKE SCALE (NIHSS) WAS 10 AND MODIFIED RANKIN SCALE SCORE (MRS) SCORE WAS ¿0- NO SYMPTOMS.¿ THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY ON (B)(6) 2023 USING A 5MM X 22MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309522/ 23B021AV) VIA A TREVO TRAK 21 MICROCATHETER (STRYKER) TARGETED AN OCCLUSION IN THE LEFT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE PRE-PASS MODIFIED TREATMENT IN CEREBRAL INFARCTION (MTICI) SCORE WAS 0. THE EMBOTRAP III DEVICE MADE ONLY ONE (1) PASS; THE FIRST PASS WITH INCUBATION TIME UNDER ONE (1) MINUTE RESULTED IN AN MTICI SCORE OF 0, WITH CLOT RETRIEVAL IN THE STENT RETRIEVER. THE SECOND PASS WAS DONE VIA DIRECT ASPIRATION DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions; Stroke/CVA

  MAUDE report 17991253 ↗
• MalfunctionOct 23, 2023Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED BY THE FIELD, AN EMBOTRAP III 5 MM X 22 MM REVASCULARIZATION DEVICE WAS REMOVED FROM THE PACKAGING AND OBSERVED KINKED. THERE WAS NO PATIENT INJURY AS REPORTED AS THE DEVICE WAS NO CLINICALLY USED. THERE WAS NO DAMAGE OBSERVED ON THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17986144 ↗
• DeathOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE EXCELLENT STUDY, THE 81-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF ISCHEMIC STROKE ((B)(6) 2023), HYPERCOAGULABLE STATE, AND HYPERTENSION PRESENTED WITH AN UNWITNESSED NON-WAKE UP STROKE. THE PATIENT WAS REPORTEDLY LAST SEEN WELL ON (B)(6) 2023 AT 21:00 HOUR. SYMPTOMS WERE FIRST OBSERVED ON (B)(6) 2023, TIME UNKNOWN. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2023 AT 18:22 HOUR. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿UNDETERMINED ETIOLOGIES.¿ THE PATIENT¿S BASELINE NIH STROKE SCALE (NIHSS) SCORE WAS 20 AND A MODIFIED RANKIN SCALE (MRS) SCORE OF 2-SLIGHT DISABILITY; UNABLE TO CARRY OUT ALL PREVIOUS ACTIVITIES, BUT ABLE TO LOOK AFTER OWN AFFAIRS WITHOUT ASSISTANCE.¿ ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING A 5MM X 22MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309522 / 22J165AV) TO TARGET AN OCCLUSION IN THE LEFT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE PRE-PASS MODIFIED TREATMENT IN CEREBRAL INFARCTION (MTICI) SCORE WAS 0. THE FIRST AND ONLY PASS RESULTED IN AN MTICI SCORE OF 2C

  Patient problems: Ischemia Stroke

  MAUDE report 17897535 ↗
• MalfunctionOct 6, 2023Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE TARGETING AN OCCLUSION IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) IN AN ELDERLY PATIENT WITH TORTUOUS VESSELS, A 5MM X 22MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309522 / 21J113AV) WAS USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS USED VIA THE COMBINED TECHNIQUE. WITH THE PATIENT¿S VESSEL BEING TORTUOUS, IT WAS REPORTED THAT DELIVERY OF DEVICES TO THE TARGET OCCLUSION WAS DIFFICULT. AFTER THE GUIDEWIRE (UNSPECIFIED BRAND) CROSSED THE THROMBOSED LESION, THE EMBOTRAP III DEVICE WAS INSERTED INTO A PHENOM¿ 21 MICROCATHETER (MEDTRONIC). THE EMBOTRAP III DEVICE GOT STUCK INSIDE THE MICROCATHETER AT ABOUT THE LAST 1/3 SECTION. THE EMBOTRAP III DEVICE WAS REMOVED AND FLUSHED WITH WATER AND ANOTHER UNSUCCESSFUL ATTEMPT WAS MADE. THE MICROCATHETER WAS REPLACED WITH ANOTHER PHENOM¿ 21 MICROCATHETER, AND THE EMBOTRAP III DEVICE ENCOUNTERED THE SAME ISSUE IN THE SIMILAR AREA OF THE REPLACEMENT MICROCATHETER. THE EMBOTRAP III DEVICE WAS REMOVED AND REPLACED WITH A 2MM X 5MM TRON STENT RETRIEVER (BIOMEDICAL SOLUTIONS, INC.), WHICH COULD BE INSERTED WITHOUT ISSUE. ONE PASS W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17892476 ↗
• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT A EMBOTRAP III 5 MM X 37 MM (ET309537/LOT # UNKNOWN) WAS USED DURING A MECHANICAL THROMBECTOMY PROCEDURE FOR AN OCCLUSION AT THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE PROCEDURE WAS DONE BY ¿COMBINED TECHNIQUE USING ASPIRATION CATHETER AND THE EMBOTRAP¿, WHICH RESULTED IN ¿TICI3 AND FULL RECANALIZATION¿. HOWEVER, ¿BLEEDING WAS FOUND IN THE PERIPHERY AREA¿. POST-PROCEDURE CHANGES IN THE PATIENT WERE REPORTED AS ¿PATIENTS DID NOT APPEAR TO BE SIGNIFICANTLY AFFECTED¿. THERE WERE NO REPORTS OF DEVICE DEFICIENCIES RELATED TO THE EMBOTRAP III DEVICE. THE PHYSICIAN COMMENTED THAT THE TIP OF THE EMBOTRAP MAY HAVE ENTERED THE THIN BRANCH AND CAUSED THE BLEEDING. THE EVENT WAS REPORTED AS SUCH: ¿THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF M2 OCCLUSION BY A COMBINED TECHNIQUE USING ASPIRATION CATHETER AND THE EMBOTRAP. THE EMBOTRAP WAS USED ACCORDING TO IFU. THE EMBOTRAP WAS APPROACHED TO THE TARGET REGION BY USING A GUIDEWIRE AND A MICROCATHETER FOR M2 OCCLUSION. THE EMBOTRAP WAS DEPLOYED AT DISTAL OF THE TARGET THROMBUS WHEN THE STENT JUST PASSED THE THROMBUS. TICI3 AND FULL RECANALIZATION WERE ACHIEVED. HOWEVER, BLEEDING WAS

  Patient problems: Intracranial Hemorrhage

  MAUDE report 17851769 ↗
• InjurySep 25, 2023Lack of Effect; Lack of Effect

  THE EVENT WAS REPORTED VIA THE EXCELLENT STUDY, THE 47-YEAR OLD MALE PATIENT WITH A HISTORY OF ATRIAL FIBRILLATION PRESENTED WITH AN UNWITNESSED WAKE-UP STROKE. THE LAST TIME HE WAS SEEN WELL WAS ON (B)(6) 2023 AT 22:00 HOUR. SYMPTOMS WERE FIRST OBSERVED ON (B)(6) 2023 AT 10:30 HOUR. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON THE SAME DAY AT 10:56 HOUR. 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 17 AND A MODIFIED RANKIN SCALE (MRS) SCORE OF 0 ¿ NO SYMPTOMS. THE PATIENT UNDERWENT A MECHANICAL THROMBECTOMY PROCEDURE ON (B)(6) 2023. THE STUDY DEVICE USED WAS A 5MM X 22MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309522 / 23D028AV); AN EMBOVAC LARGE BORE CATHETER (IC71132CA / 31041010) WAS ALSO USED. THE PRE-PASS MODIFIED TREATMENT IN CEREBRAL INFARCTION (MTICI) SCORE WAS 0. THE FIRST THREE (3) PASSES WERE MADE USING THE EMBOTRAP III DEVICE AND THE EMBOVAC LARGE BORE CATHETER. THE PASS SEQUENCE IS AS FOLLOWS: THE FIRST PASS WAS MADE VIA A HEADWAY® 21 MICROCATHETER (MICROVENTION) WITH THE EMBOVAC TARGETING THE RIGHT A1 SEGM

  Patient problems: Ischemia Stroke

  MAUDE report 17808346 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT UNDERWENT A MECHANICAL THROMBECTOMY PROCEDURE THAT TARGETED AN OCCLUSION AT THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). DURING THE PROCEDURE, A 5MM X 22MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309522 / LOT# UNKNOWN) WAS USED VIA THE SOLUMBRA TECHNIQUE. SEVERAL HOURS AFTER THE PROCEDURE, A HEMORRHAGE WAS RECOGNIZED. IT IS NOT KNOWN IF THE PATIENT EXPERIENCED ANY SYMPTOMS OR IF THE HEMORRHAGE REQUIRED ADDITIONAL MEDICAL AND/OR SURGICAL INTERVENTION. ON 01-SEP-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE LOT NUMBER OF THE EMBOTRAP III DEVICE USED IS NOT KNOWN. THE PROCEDURE DATE WAS (B)(6) 2023. IN RESPONSE TO THE QUESTION OF CLOT CHARACTERISTICS, INCLUDING LENGTH AND DENSITY, A PHOTO WAS INCLUDED THAT DEPICTED THE STENT COMPONENT OF THE EMBOTRAP III BEING HELD IN A GLOVED HAND WITH A CLOT. NO DIMENSIONS OR ANY DESCRIPTION WAS INCLUDED. THE TYPE OF BLEED (INTRAPARENCHYMAL OR SUBARACHNOID) WAS NOT KNOWN. IT WAS NOT KNOWN IF THERE WAS ANY VESSEL TRAUMA / INJURY THAT MAY HAVE RESULTED IN THE REPORTED BLEED. INFORMATION RELATED TO AVAILABILITY OF ANONYMIZED PROCEDURE IMAGES / ANGIOGRAPHS, PRE

  Patient problems: Intracranial Hemorrhage

  MAUDE report 17687398 ↗
• DeathAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE EXCELLENT STUDY (B)(6), A 93-YEAR-OLD FEMALE (SUBJECT (B)(6)) WITH A HISTORY OF ATRIAL FIBRILLATION AND HYPERTENSION PRESENTED WITH AN UNWITNESSED WAKE UP STROKE. THE LAST TIME SEEN WELL WAS (B)(6) 2023 AT 06:40. SYMPTOMS WERE FIRST OBSERVED ON (B)(6) 2023 AT 06:45. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2023 AT 09:10, WHERE CT IMAGING CONFIRMED AN ISCHEMIC STROKE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADMINISTERED. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿CARDIOEMBOLIC¿. THE PATIENT¿S BASELINE NIHSS SCORE WAS 7 AND MODIFIED RANKIN SCALE SCORE (MRS) SCORE WAS 4- -MODERATELY SEVERE DISABILITY. UNABLE TO WALK WITHOUT ASSISTANCE AND UNABLE TO ATTEND TO OWN BODILY NEEDS WITHOUT ASSISTANCE. ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY FOR AN OCCLUSION AT THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING AN EMBOTRAP III 5 MM X 22 MM (ET309522/23B021AV). THE PRE-PASS MTICI SCORE WAS 0. THE 1ST PASS RESULTED IN A MTICI SCORE OF 3, WITH CLOT RETRIEVAL. DURING THE PROCEDURE, A GUIDEWIRE WAS USED, BUT THE BRAND WAS NOT SPECIFIED. A 0.021 TREVO MICROCATHETER, A 0.060 CAT INTERMEDIATE CATHETER,

  Patient problems: Obstruction/Occlusion; Stroke/CVA

  MAUDE report 17595755 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE EVENT OCCURRED DURING A MECHANICAL THROMBECTOMY PROCEDURE TARGETING AN OCCLUSION IN THE PROXIMAL M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A 5MM X 22MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309522 / LOT#: UNKNOWN). IT WAS REPORTED THAT ¿THE EMBOTRAP III WAS INSERTED INTO THE M2 DISTAL AND DEPLOYED. CONTINUOUS FLUSH WAS MAINTAINED. THE VASCULAR SHAPE WAS CONFIRMED TO BE STRAIGHT AND THERE WAS NO RESISTANCE, SO THE THROMBUS WAS RETRIEVED SLOWLY. IMMEDIATELY AFTER, IMAGING SHOWED NO PROBLEM.¿ THEN ¿A CLOT MOVED TO THE A2 AND [WAS] RETRIEVED. AFTER THAT, THE IMAGING SHOWED BLEEDING FROM [THE] M2 [SEGMENT].¿ IT WAS REPORTED THAT POST-PROCEDURE, PARALYSIS REMAINED, BUT THE PATIENT CONDITION WAS NOT WORSENED BY THE BLEED. THE PATIENT CONDITION REPORTEDLY WAS UNCHANGED FROM THE TIME THE PATIENT WAS BROUGHT TO THE HOSPITAL. THE PHYSICIAN COMMENTED THAT ¿THE SEVERITY [OF THE BLEED] WAS MINOR TO MODERATE, AS THE PATIENT CONDITION REMAINED UNCHANGED. IN ADDITION, THE PATIENT¿S VESSELS WERE ORIGINALLY FRAGILE. SINCE HEPARIN WAS ADDED AFTER THROMBUS RETRIEVAL BY THE EMBOTRAP III DEVICE, THIS ALSO MIGHT HAVE [BEEN] AFFECTED.¿ THE PHYSICI

  Patient problems: Intracranial Hemorrhage; Paralysis; Thromboembolism

  MAUDE report 17379404 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE FOR AN ACUTE CEREBRAL INFARCTION WITH THE OCCLUSION AT THE DISTAL M1 (M1D) SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA), BECAUSE THE RIGHT AND LEFT FEMORAL ARTERIES AND THE RIGHT BRACHIAL ARTERY WERE DIFFICULT TO PUNCTURE, A COMMON CAROTID ARTERY (CCA) WAS PUNCTURED AS THE ACCESS POINT FOR THE APPROACH. A 9FR BRANCHOR BALLOON GUIDE CATHETER (ASAHI-INTECC) WAS INSERTED INTO THE INTERNAL CAROTID ARTERY (ICA), THEN THE MICROCATHETER, A PHENOM¿ 21 MICROCATHETER (MEDTRONIC) AND ASPIRATION CATHETER, A 5F SOFIA¿ FLOW PLUS ASPIRATION CATHETER (MICROVENTION) WERE INSERTED INTO THE M1 SEGMENT OF THE MCA. THE FIRST PASS WAS MADE; ASPIRATE A THROMBUS USING THE ASPIRATION CATHETER AND A SMALL AMOUNT OF THROMBUS WAS RETRIEVED. ON THE SECOND PASS, THE THROMBUS WAS COLLECTED USING THE COMBINED METHOD WITH A 5MM X 22MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309522 / 22J017AV) AND THE ASPIRATION CATHETER. AN M2 OCCLUSION WAS FOUND. ON THE THIRD PASS, THROMBUS WAS COLLECTED VIA THE COMBINED METHOD WITH THE EMBOTRAP III AND ASPIRATION CATHETER. A RUPTURE WAS FOUND AT THE PROXIMAL M2 SEGMENT AND COIL EMBOLIZATIO

  Patient problems: Perforation of Vessels

  MAUDE report 17329441 ↗
• InjuryJul 5, 2023Break; Break

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE WITH THE TARGET OCCLUSION IN THE MIDDLE CEREBRAL ARTERY (MCA). A FEMORAL ARTERY APPROACH WAS MADE. ANGIOGRAPHY CATHETER AND 35 WIRE WAS INSERTED IN THE 9FR OPTIMO¿ BALLOON GUIDE CATHETER (TOKAI MEDICAL) TO THE INTERNAL CAROTID ARTERY (ICA). THE INNER CATHETER WAS REMOVED AND THE SOFIA¿ 6F INTERMEDIATE CATHETER (MICROVENTION) AND PHENOM¿ 27 MICROCATHETER (MEDTRONIC) WAS ADVANCED TO THE MCA. AFTER ANGIOGRAPHY, THE COMPLAINT DEVICE, A 5MM X 22MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309522 / 22J017AV) WAS INSERTED INTO THE PHENOM MICROCATHETER AND DEPLOYED AT THE M2 SEGMENT. RECANALIZATION WAS NOT ACHIEVED AFTER THE FIRST PASS. ASPIRATION CATHETER WAS CHANGED TO A AXS VECTA 46 INTERMEDIATE CATHETER (STRYKER) ON THE SECOND PASS AND THE THROMBUS WAS RETRIEVED BY THE COMBINED TECHNIQUE WITH THE EMBOTRAP III DEVICE. IT WAS REPORTED THAT ¿THE OCCLUDED LESION BECAME M3 AND THE PROCEDURE WAS COMPLETED.¿ POST-OPERATIVE CONE-BEAM COMPUTED TOMOGRAPHY (CT) SCAN SHOWED ARTIFACTS AND THE PHYSICIAN COMMENTED THAT ¿THE EMBOTRAP III MIGHT BE DAMAGED.¿ THE PHYSICIAN REQUESTED ANALYSIS OF THE EMBOTRAP III DEVICE THA

  Patient problems: Obstruction/Occlusion

  MAUDE report 17263028 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT ON (B)(6) 2023, A PATIENT WITH A HISTORY OF ATRIAL FIBRILLATION UNDERWENT A MECHANICAL THROMBECTOMY PROCEDURE FOR AN ACUTE ISCHEMIC STROKE (AIS) WITH THE TARGET OCCLUSION IN THE MIDDLE CEREBRAL ARTERY (MCA). THE PHYSICIAN USES THE EMBOTRAP FREQUENTLY ON A DAILY BASIS, ¿SO NO PROBLEM WITH ITS USE OR TECHNIQUE.¿ THE MECHANICAL THROMBECTOMY PROCEDURE WAS TARGETING AN M2 OCCLUSION USING A 5MM X 22MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309522 / LOT# UNKNOWN) VIA A PHENOM MICROCATHETER (MEDTRONIC). THE THROMBUS WAS SUCCESSFULLY RETRIEVED, BUT POST-OPERATIVE COMPUTED TOMOGRAPHY (CT) IMAGES SHOWED MINOR BLEEDING. THE ASYMPTOMATIC INTRACRANIAL HEMORRHAGE OCCURRED AND NO SPECIAL INTERVENTION WAS REQUIRED. THE PATIENT WAS ASYMPTOMATIC AND WAS PLACED UNDER OBSERVATION. THE PATIENT WAS THEN REPORTED TO BE DISCHARGED FROM THE HOSPITAL ¿ON A LATER DATE, AFTER GOOD IMPROVEMENT WAS OBSERVED.¿ CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. THE PHYSICIAN COMMENTED THAT ¿THERE IS CAUSAL RELATIONSHIP BETWEEN THE ISSUE AND THE PRODUCT. ONE OF THE REASONS FOR THE ISSUE WAS THOUGHT THAT THE EMBOTRAP WAS USED AT THE TORTUOUS M2 LESION. ALSO, ENDOTHELIAL

  Patient problems: Intracranial Hemorrhage

  MAUDE report 17213768 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT ON (B)(6) 2023, A PATIENT WITH A HISTORY OF ATRIAL FIBRILLATION UNDERWENT A MECHANICAL THROMBECTOMY PROCEDURE FOR AN ACUTE ISCHEMIC STROKE (AIS) WITH THE TARGET OCCLUSION IN THE MIDDLE CEREBRAL ARTERY (MCA). THE PHYSICIAN USES THE EMBOTRAP FREQUENTLY ON A DAILY BASIS, ¿SO NO PROBLEM WITH ITS USE OR TECHNIQUE.¿ THE MECHANICAL THROMBECTOMY PROCEDURE WAS TARGETING AN M2 OCCLUSION USING A 5MM X 22MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309522 / LOT#: UNKNOWN) VIA A TRAK MICROCATHETER (STRYKER). THE THROMBUS WAS SUCCESSFULLY RETRIEVED AND RECANALIZATION WAS ACHIEVED, BUT POST-OPERATIVE COMPUTED TOMOGRAPHY (CT) IMAGES SHOWED MINOR BLEEDING. THE ASYMPTOMATIC INTRACRANIAL HEMORRHAGE OCCURRED AND NO SPECIAL INTERVENTION WAS REQUIRED. THE PATIENT WAS ASYMPTOMATIC AND WAS PLACED UNDER OBSERVATION. THE PATIENT WAS THEN REPORTED TO BE DISCHARGED FROM THE HOSPITAL ¿ON A LATER DATE, AFTER GOOD IMPROVEMENT WAS OBSERVED.¿ CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. THE PHYSICIAN COMMENTED THAT ¿THERE IS CAUSAL RELATIONSHIP BETWEEN THE ISSUE AND THE PRODUCT. THE MULTIPLE PASSES AT THE LESION SITE MIGHT HAVE INFLUENCED THE ISSUE. ALSO, ENDOTHELI

  Patient problems: Intracranial Hemorrhage

  MAUDE report 17213747 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT ON (B)(6) 2023, A PATIENT WITH A HISTORY OF ATRIAL FIBRILLATION UNDERWENT A MECHANICAL THROMBECTOMY PROCEDURE FOR AN ACUTE ISCHEMIC STROKE (AIS). DURING THE PROCEDURE, A 5MM X 22MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309522 / LOT# UNKNOWN) WAS USED FOR AN M2 OCCLUSION. THE EMBOTRAP III DEVICE WAS PREPPED AND USED AS USUAL WITHOUT ANY PROBLEMS. IT WAS DELIVERED VIA A PHENOM MICROCATHETER (MEDTRONIC) TO THE M2 OCCLUSION AND ¿PULLED WITH THE THROMBUS.¿ THE VESSEL / VASCULAR TORTUOSITY SURROUNDING THE M2 LESION ¿WAS STRONG AND TORTUOUS AND THE PATIENT SEEM TO HAVE HAD SOME PAIN DURING THE PROCEDURE.¿ IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED, BUT POST-OPERATIVE COMPUTED TOMOGRAPHY (CT) IMAGES SHOWED MINOR BLEEDING. THE ASYMPTOMATIC INTRACRANIAL HEMORRHAGE OCCURRED AND NO SPECIAL INTERVENTION WAS REQUIRED. THE PATIENT WAS ASYMPTOMATIC AND WAS PLACED UNDER OBSERVATION. THE PATIENT WAS THEN REPORTED TO BE DISCHARGED FROM THE HOSPITAL ¿ON A LATER DATE, AFTER GOOD IMPROVEMENT WAS OBSERVED.¿ CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. THE PHYSICIAN COMMENTED THAT ¿THERE IS CAUSAL RELATIONSHIP BETWEEN THE ISSUE AND T

  Patient problems: Intracranial Hemorrhage; Pain

  MAUDE report 17213734 ↗
• MalfunctionMay 30, 2023Retraction Problem; Material Twisted/Bent; Retraction Problem; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE TO TREAT AN ISCHEMIC STROKE IN A 92-YEAR-OLD FEMALE PATIENT, THE 5MM X 22MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309522 / 22L202AV) WAS DELIVERED TO THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) VIA A PROWLER EX MICROCATHETER (MC2165S2U / 30989723). IT WAS REPORTED BY A STAFF MEMBER THAT THE PHYSICIAN FELT RESISTANCE WHEN REMOVING THE EMBOTRAP III DEVICE. THE EMBOTRAP III DEVICE AND THE PROWLER EX MICROCATHETER WERE REMOVED FROM THE VESSEL. AFTER REMOVAL, DAMAGE TO THE DISTAL END OF THE PROWLER EX MICROCATHETER WAS NOTICED. THERE WAS ALSO DAMAGE TO THE DISTAL END OF THE EMBOTRAP III DEVICE. ¿IT APPEARED THAT THE DISTAL END OF THE EMBOTRAP FOLDED BACK ON ITSELF.¿ OTHER DEVICES WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO FRAGMENTS GENERATED FROM THE DEVICES. THE PROCEDURE WAS NOT DELAYED DUE TO THE REPORTED EVENT. THERE WAS NO NEGATIVE PATIENT IMPACT. THE PROWLER EX MICROCATHETER IS NOT AVAILABLE FOR RETURN. ON 26-MAY-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE CLOT CHARACTERISTICS AND VESSEL TORTUOSITY ARE NOT KNOWN. ONE PASS WAS MADE WITH THE EMBOTRAP III AND T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17027914 ↗