EMBOTRAP ET309537Recalls & reported problems

Summary

The FDA's MAUDE database contains 177 adverse event reports that list this exact device (DI 10886704084570), received between Sep 28, 2020 and Sep 9, 2026 — classified as 13 deaths, 115 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (24 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 177 reports, in the reporter's own words as published by the FDA.

• DeathSep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported, via a personal interaction, that an EMBOTRAP III 5 MM X 37 MM (ET309537/ 26A020AV) and a 132CM CEREGLIDE 71 CATHETER (NIC71132C/ 31867850) were used for a mechanical thrombectomy procedure to treat an occlusion at the M1 segment of the middle cerebral artery (MCA) for an acute ischemic stroke using combined technique. During the procedure, the thrombus was successfully retrieved and no malfunctions were reported. Although the thrombectomy was successful, it was discovered during a follow-up interview for the case that the patient had died. The physician commented that the event was not product-related, and that peripheral vessel rupture and hemorrhage occurred due to the hemodynamic load after reperfusion. Additionally, it was reported that the patient¿s advanced age and the large hemodynamic load from reperfusion likely contributed to vessel rupture.The event was initially reported as such, ¿The procedure was a mechanical thrombectomy of middle cerebral artery M1 to treat acute ischemic stroke with a combined technique using the Cereglide 71 and EmboTrap III 5x37. The devices were used according to IFU. Thrombectomy was performed following the standard procedural

  Patient problems: Intracranial Hemorrhage

  MAUDE report 50696981 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT AN EMBOTRAP III 5 MM X 37 MM (ET309537/ 25L363AV) WAS USED FOR A MECHANICAL THROMBECTOMY OF THE MIDDLE CEREBRAL ARTERY M2 (WITH TWO OCCLUSION SITES) TO TREAT CEREBRAL INFARCTION, WHICH WAS PERFORMED BY COMBINED TECHNIQUE. IT WAS REPORTED THAT THE PATIENT HAD SUFFERED A STROKE ¿SOME TIME AGO.¿ DURING THE PROCEDURE, SUCCESSFUL RECANALIZATION (TICI 3) WAS ACHIEVED WITH TWO PASSES; HOWEVER, A POSTOPERATIVE HEMORRHAGIC COMPLICATION WAS OBSERVED. THE PATIENT WAS LEFT WITH RESIDUAL NEUROLOGICAL DEFICITS. THE PHYSICIAN COMMENTED THAT IT WAS CONSIDERED UNLIKELY THAT THERE WAS A CAUSAL RELATIONSHIP WITH THE EMBOTRAP III DEVICE. POTENTIAL CAUSES OTHER THAN THE EMBOTRAP III WAS REPORTED AS ¿PROLONGED TIME FROM SYMPTOM ONSET AND THE PATIENT¿S ADVANCED AGE.¿ CONTINUOUS FLUSH WAS NOT DONE. OTHER DEVICES USED DURING THE PROCEDURE ARE UNKNOWN. THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF MIDDLE CEREBRAL ARTERY M2 OCCLUSION TO TREAT CEREBRAL INFARCTION, WHICH WAS PERFORMED BY COMBINED TECHNIQUE. THE DEVICES WERE USED ACCORDING TO IFU. THE TARGET WAS AN M2 OCCLUSION, WITH TWO OCCLUSION SITES IDENTIFIED. THE

  Patient problems: Intracranial Hemorrhage; Unspecified Nervous System Problem

  MAUDE report 24939558 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT AN EMBOTRAP III 5 MM X 37 MM (ET309537/25K286AV) WAS USED FOR A MECHANICAL THROMBECTOMY OF THE MIDDLE CEREBRAL ARTERY M1 OCCLUSION TO TREAT CEREBRAL INFARCTION, WHICH WAS PERFORMED BY COMBINED TECHNIQUE. DURING THE PROCEDURE, SUCCESSFUL RECANALIZATION (TICI 3) WAS ACHIEVED IN ONE PASS; HOWEVER, A POSTOPERATIVE HEMORRHAGIC COMPLICATION WAS OBSERVED. THE PATIENT WAS LEFT WITH RESIDUAL NEUROLOGICAL DEFICITS. NO FURTHER TREATMENT IS PLANNED. THE PHYSICIAN COMMENTED THAT ALTHOUGH IT IS UNCLEAR WHETHER THERE IS A CAUSAL RELATIONSHIP WITH EMBOTRAP III, A POSTOPERATIVE HEMORRHAGIC COMPLICATION WAS OBSERVED. POTENTIAL CAUSES OTHER THAN THE EMBOTRAP III WAS REPORTED AS "THE EFFECT OF TPA MAY BE CONSIDERED; HOWEVER, THIS REMAINS UNCERTAIN." CONTINUOUS FLUSH WAS NOT DONE. ANOTHER DEVICE USED DURING THE PROCEDURE WAS A CEREGLIDE71 INTERMEDIATE CATHETER. THE EVENT WAS INITIALLY REPORTED AS SUCH, "THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF MIDDLE CEREBRAL ARTERY M1 OCCLUSION TO TREAT CEREBRAL INFARCTION, WHICH WAS PERFORMED BY COMBINED TECHNIQUE. THE DEVICES WERE USED ACCORDING TO IFU. USING THE EMBOTRAP III WITH A COMBINED TECHNIQUE, SUCCESSF

  Patient problems: Intracranial Hemorrhage; Unspecified Nervous System Problem

  MAUDE report 24939345 ↗
• MalfunctionApr 2, 2026Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS A MECHANICAL THROMBECTOMY OF MIDDLE CEREBRAL ARTERY IN TREATING MAJOR ARTERY OCCLUSION (ACUTE ISCHEMIC STROKE). THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). AFTER CROSSING THE LESION WITH A PHENOM 21 MICROCATHETER, THE EMBOTRAP III 5 MM X 37 MM (PRODUCT CODE: ET309537, LOT NUMBER: 25J206AV) WAS INSERTED, BUT RESISTANCE WAS ENCOUNTERED AND IT COULD NOT BE DELIVERED. THE EMBOTRAP III WAS THEN REPLACED WITH ANOTHER NEW EMBOTRAP III OF THE SAME PRODUCT CODE, AND IT WAS SUCCESSFULLY DELIVERED THROUGH THE SAME PHENOM 21. SUBSEQUENTLY, RECANALIZATION WAS ACHIEVED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. ADDITIONAL EVENT INFORMATION RECEIVED INDICATED THAT A CONTINUOUS FLUSH WAS MAINTAINED. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THERE WERE NO NOTABLE VESSEL CHARACTERISTICS. THERE WAS NO VISIBLE DAMAGE TO THE DEVICE. BASED ON THE PRODUCT ANALY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767592 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE ON (B)(6) 2026, THE 132CM CEREGLIDE 71 CATHETER (NIC71132C / 31457320) AND TWO (2) 5MM X 37MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309537) FROM THE SAME LOT NUMBER (25B080AV) WERE USED. A VESSEL DISSECTION OCCURRED AT THE SITE WHERE THE 132CM CEREGLIDE 71 CATHETER AND THE EMBOTRAP III DEVICE WERE USED. THE PHYSICIAN OPINED THAT THERE IS A RELATIONSHIP BETWEEN THE DEVICES AND THE ADVERSE EVENT. THE PHYSICIAN MENTIONED THAT ¿THE POSSIBILITY THAT THE SELECTED SIZE OF THE EMBOTRAP III MAY HAVE BEEN TOO LARGE.¿ AT THE TIME OF THE COMPLAINT INITIATION, THE PATIENT¿S CLINICAL COURSE AND POST-PROCEDURE STATUS WAS REPORTED AS UNKNOWN. ON 08-MAR-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THE PATIENT¿S ORIGINAL PRESENTING SYMPTOMS WAS ¿ACUTE ISCHEMIC STROKE.¿ IT IS NOT KNOWN IF CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 24547473 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE ON (B)(6) 2026, THE 132CM CEREGLIDE 71 CATHETER (NIC71132C / 31457320) AND TWO (2) 5MM X 37MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309537) FROM THE SAME LOT NUMBER (25B080AV) WERE USED. A VESSEL DISSECTION OCCURRED AT THE SITE WHERE THE 132CM CEREGLIDE 71 CATHETER AND THE EMBOTRAP III DEVICE WERE USED. THE PHYSICIAN OPINED THAT THERE IS A RELATIONSHIP BETWEEN THE DEVICES AND THE ADVERSE EVENT. THE PHYSICIAN MENTIONED THAT ¿THE POSSIBILITY THAT THE SELECTED SIZE OF THE EMBOTRAP III MAY HAVE BEEN TOO LARGE.¿ AT THE TIME OF THE COMPLAINT INITIATION, THE PATIENT¿S CLINICAL COURSE AND POST-PROCEDURE STATUS WAS REPORTED AS UNKNOWN. ON 08-MAR-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THE PATIENT¿S ORIGINAL PRESENTING SYMPTOMS WAS ¿ACUTE ISCHEMIC STROKE.¿ IT IS NOT KNOWN IF CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 24547467 ↗
• MalfunctionFeb 18, 2026Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF THE MIDDLE CEREBRAL ARTERY IN TREATING CEREBRAL INFARCTION. THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). AFTER ADVANCING THE EMBOTRAP III 5 MM X 37 MM (PRODUCT CODE: ET309537, LOT NUMBER: 23B146AV), CROSSED THE LESION USING A CEREGLIDE 71 CATHETER AND A PHENOM 21 MICROCATHETER (MC). THEN ATTEMPTED TO INSERT THE EMBOTRAP III INTO THE MICROCATHETER BUT FELT RESISTANCE AROUND THE HUB AND WERE UNABLE TO ADVANCE IT. THE EMBOTRAP III WAS REPLACED WITH A TIGERTRIEVER THROMBECTOMY DEVICE AND USED THE SAME MICROCATHETER. HOWEVER, IT COULD NOT BE INSERTED, SO THE PROCEDURE WAS CONTINUED. THROMBUS WAS RETRIEVED IN ONE PASS, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO POST-PROCEDURE CHANGES IN THE PATIENT. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICES WERE EMBOGUARD GUIDING CATHETER, PHENOM MICROCATHETER. ADDITIONAL EVENT INFORMATION RECEIVED ON 03-FEB-2026 INDICATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THERE WAS NO CONSPICUOUS CALCIFICATION OR BEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378763 ↗
• MalfunctionJan 21, 2026Failure to Advance; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY TO TREAT AN ACUTE ISCHEMIC STROKE (AIS) EVENT, DEVICES WERE USED IN ACCORDANCE WITH THEIR INSTRUCTIONS FOR USE (IFUS). DURING THE INSERTION OF THE 5MM X 37MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309537 / 25J055AV), RESISTANCE WAS FELT AT THE HUB OF THE CONCOMITANT HEADWAY® MICROCATHETER (TERUMO NEURO). CONTINUOUS FLUSH WAS MAINTAINED. UPON REMOVAL, THE STENT BODY WAS FOUND TO BE DEFORMED. THE EMBOTRAP III DEVICE WAS REPLACED, ¿WHICH COULD BE USED WITH THE SAME MICROCATHETER WITHOUT ANY PROBLEMS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.¿ THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ON 18-JAN-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE REPLACEMENT STENT WAS ANOTHER 5MM X 37MM EMBOTRAP III (ET309537).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24137905 ↗
• MalfunctionDec 3, 2025Difficult to Remove; Lack of Effect; Difficult to Remove; Lack of Effect

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE TARGETING THE M1 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) WITH STRONG VESSEL DEVIATION, A TOTAL OF 7 PASSES WERE MADE. THEY ARE DOCUMENTED AS FOLLOWS: THE FIRST PASS WAS VIA AN ADAPT (DIRECT ASPIRATION FIRST PASS TECHNIQUE) USING A 0.060-INCH ACCESS CATHETER. ¿MUCH RESISTANCE WAS NOT FELT, BUT THE PHYSICIAN WAS HESITANT TO INSERT THE CATHETER [INTO THE] M2, SO ASPIRATION WAS MADE AFTER COMPLETELY REMOVING THE MICROCATHETER.¿ THREE PASSES WERE MADE VIA THE COMBINED TECHNIQUE WITH THE 0.060-INCH ACCESS CATHETER AND THE 5MM X 37MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309537 / LOT# UNKNOWN). STRONG RESISTANCE WAS FELT. THE FIFTH PASS WAS VIA THE COMBINED TECHNIQUE USING A 0.046-INCH ACCESS CATHETER AND THE 5MM X 37MM EMBOTRAP III REVASCULARIZATION DEVICE. STRONG RESISTANCE WAS FELT. THE SIXTH PASS, THE EMBOTRAP III WAS PULLED BACK WITH THROMBI INTO THE ACCESS CATHETER. ¿AT THIS TIME, DEPLOYED THE EMBOTRAP III SHORTER AND ATTEMPTED TO OVERCOME THE RESISTANCE AND THE VESSEL DEVIATION, BUT COULD NOT ACHIEVE RECANALIZATION.¿ ON THE SEVENTH PASS, THE ¿EMBOTRAP III WAS PULLED BACK WITH THROMBI I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709846 ↗
• MalfunctionNov 21, 2025Difficult to Remove; Difficult to Remove

  A HEALTHCARE PROFESSION REPORTED THAT THIS WAS A MECHANICAL THROMBECTOMY OF A MIDDLE CEREBRAL ARTERY, SEGMENT M1 DISTAL OCCLUSION FOR CEREBRAL INFARCTION. THE ASPIRATION CATHETER (UNKNOWN COMPETITOR'S PRODUCT) COULD ONLY BE ADVANCED TO THE IC TOP, AND THE EMBOTRAP III 5 MM X 37 MM (ET309537, 23E097AV) WAS INSERTED AND DEPLOYED FROM M2. WHEN THE EMBOTRAP III DELIVERY WIRE WAS PULLED, IT COULD BE PULLED WITHOUT RESISTANCE FIRST, BUT WHEN THE DISTAL BASKET REACHED AT M1, STRONG RESISTANCE WAS FELT AND COULD NOT PULL FURTHER. THE TRAK21 MICROCATHETER (MC) WAS ADVANCED OVER THE EMBOTRAP III AND ATTEMPTED TO RE-SHEATH, BUT THE MC COULD NO LONGER BE ADVANCED BEYOND THE M1 MIDDLE. INSTEAD, WHEN THE ASPIRATION CATHETER WAS ADVANCED DISTALLY AGAIN, THE RESISTANCE WAS RESOLVED AND COULD BE REMOVED. THE THROMBUS WAS RETRIEVED, AND RECANALIZATION WAS OBTAINED. NO BLEEDING WAS FOUND. THE VESSEL WAS SEVERELY TORTUOUS. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT NOR BLEEDING. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS DONE. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-DEC-2023 AND 26-DEC-2023 INDICATED THAT RESISTANCE WAS ENCOUNTERED AT THE DISTAL BASKET WHEN REACHED THE M1 SEGMENT. THE DEVICE WAS STU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622470 ↗
• MalfunctionOct 31, 2025Failure to Advance; Failure to Advance

  ON 31-AUG-2025, THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE THERE WAS ISSUE WITH THE USE OF AN EMBOTRAP DEVICE. ADDITIONAL INFORMATION IS PENDING. ON 04-SEP-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS A MECHANICAL THROMBECTOMY PROCEDURE TARGETING AN OCCLUSION IN THE DISTAL M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). A 125CM CEREGLIDE 71 INTERMEDIATE CATHETER WAS USED AS ASPIRATION CATHETER WITH AN ENVI¿-SR (NEUROVASC TECHNOLOGIES) AND A SOLITAIRE¿ REVASCULARIZATION DEVICE (MEDTRONIC) WERE USED. AFTER SEVERAL PASSES, THE THROMBUS COULD NOT BE REMOVED AND THE 5MM X 37MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309537 / 25D152AV) WAS USED. WHEN THE EMBOTRAP III DEVICE WAS INSERTED INTO THE CONCOMITANT PHENOM ¿ 21 CATHETER (MEDTRONIC), THE EMBOTRAP III BECAME STUCK AND COULD NOT BE DELIVERED, RENDERING IT UNUSABLE. THE PROCEDURE WAS ABORTED WITH TICI SCORE OF 1. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. PRELIMINARY PHOTOS OF THE DEVICE WERE ADDED TO THE COMPLAINT ON 07-SEP-2025. ON 08-SEP-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION CONFIRMED THE TARGET WAS AN OCCLUSION IN THE DISTAL M1

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439757 ↗
• InjuryAug 13, 2025Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA PERSONAL INTERACTION, THAT AN EMBOTRAP III 5 MM X 37 MM (ET309537/ 25D258AV) WAS USED FOR A MECHANICAL THROMBECTOMY PROCEDURE OF BASILAR ARTERY BY COMBINED TECHNIQUE. THE PROCEDURE WAS INITIATED FOLLOWING THE PREPARATION OF THE EMBOTRAP III DEVICE. DURING THE PROCEDURE, THE PATIENT EXPERIENCED CARDIOPULMONARY ARREST, CAUSED BY DISSECTION OR STENOSIS. THE STENOTIC SEGMENT WAS SUBSEQUENTLY DILATED USING A SOLITAIRE DEVICE (MEDTRONIC). THE PATIENT¿S CONDITION REMAINED THE SAME AS IT DID PRIOR TO THE PROCEDURE. THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿1. OVERVIEW OF THE PROCEDURE. THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF BASILAR ARTERY BY COMBINED TECHNIQUE. 2. DETAILS OF THE PROCEDURE: THE DEVICES WERE USED ACCORDING TO IFU. AFTER PREPARING THE EMBOTRAP III, THE PROCEDURE WAS INITIATED. CARDIOPULMONARY ARREST OCCURRED CAUSED BY DISSECTION OR STENOSIS. THE STENOTIC AREA WAS EXPANDED USING SOLITAIRE. THE PROCEDURE WAS COMPLETED. 3. POST-PROCEDURE CHANGES IN THE PATIENT. THE PATIENT CONDITION WAS NOT CHANGED FROM BEFORE THE PROCEDURE. CONTINUOUS FLUSH WAS UNKNOWN. THE LESION WAS BASILAR ARTERY. OTHER CONCOMITANT DEVICE WAS PHENOM MICROCATHETER.¿ ADDITIONAL IN

  Patient problems: Cardiac Arrest; Vascular Dissection

  MAUDE report 22796261 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE EXCELLENT STUDY (B)(4), AN 84-YEAR-OLD FEMALE (SUBJECT: (B)(6) WITH A MEDICAL HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), HYPERLIPIDEMIA, AND HYPERTENSION, PRESENTED WITH A WITNESSED STROKE ON (B)(6) 2023 AT 15:45. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON THE SAME DAY AT 17:43, WHERE CT IMAGING CONFIRMED AN ISCHEMIC STROKE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿CARDIOEMBOLIC.¿ THE PATIENT¿S BASELINE NIHSS SCORE WAS 12 AND THE MODIFIED RANKIN SCALE MRS SCORE WAS ¿0-NO SYMPTOMS.¿ ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING AN EMBOTRAP III (ET307537/ LOT#: UNKNOWN) FOR OCCLUSIONS AT THE LEFT CAROTID T AND M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE PRE-PASS MTICI SCORE WAS 0. THE 1ST PASS RESULTED IN A MTICI SCORE OF 3 WITH CLOT RETRIEVAL IN THE ¿ASPIRATION - IC, LS OR BGC.¿ NO FURTHER PASSES WERE MADE. DURING THE PROCEDURE, A GUIDEWIRE WAS USED, BUT THE BRAND WAS NOT SPECIFIED. IN ADDITION, A 0.021 REBAR MICROCATHETER AND A 0.07 SOFIA PLUS INTERMEDIATE CATHETER WERE ALSO USED. THERE WERE N

  Patient problems: Obstruction/Occlusion

  MAUDE report 22777651 ↗
• MalfunctionAug 11, 2025Entrapment of Device; Entrapment of Device

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS A MECHANICAL THROMBECTOMY OF THE MIDDLE CEREBRAL ARTERY WITH SEGMENT M2 OCCLUSION WAS INITIATED. CAROTID ARTERY STENTING OF COMMON CAROTID ARTERY WAS ALSO PERFORMED CONCOMITANTLY. WHEN THE ASPIRATION CATHETER WAS INSERTED, IT WAS UNABLE TO PASS BEYOND THE PROTAGE STENT DEPLOYED IN THE COMMON CAROTID ARTERY. THEN, AN EMBOTRAP III 5 MM X 37 MM (ET309537, 24F016AV) WAS DELIVERED TO THE M2 OCCLUSION SITE AND DEPLOYED. AFTER RETRIEVING THE THROMBUS AND WITHDRAWING IT WITH THE EMBOTRAP III, THE EMBOTRAP III STENT BECAME CAUGHT ON THE PROTAGE IN THE COMMON CAROTID ARTERY AND COULD NOT BE REMOVED. A 6FR INNER CATHETER WAS INSERTED TO RETRIEVE THE EMBOTRAP III STENT. THE EMBOTRAP III WAS PULLED FROM THE PATIENT¿S BODY, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS UNKNOWN. OTHER CONCOMITANT DEVICES WERE OPTIMO 8FR GUIDING CATHETER AND A PHENOM MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770380 ↗
• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE EXCELLENT STUDY (B)(6), A 42-YEAR-OLD MALE (SUBJECT(B)(6)) WITH A MEDICAL HISTORY OF HYPERTENSION, AND ACTIVE SMOKER, PRESENTED WITH A WITNESSED STROKE ON (B)(6) 2023, AT 11:40. THE PATIENT WAS THEN PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2023, AT 13:23, WHERE CT IMAGING CONFIRMED AN ISCHEMIC STROKE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADMINISTERED AT THE TIME OF STROKE PRESENTATION, AT 14:09. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿LARGE-ARTERY DISEASE (INTRACRANIAL ATHEROSCLEROSIS).¿ THE PATIENT¿S BASELINE NIHSS SCORE WAS 16 AND MODIFIED RANKIN SCALE (MRS) SCORE OF ¿0- NO SYMPTOMS.¿ ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING AN EMBOTRAP III 5 MM X 37 MM (ET309537/ 23B074AV) AND A 132CM EMBOVAC LARGE BORE 71 CATHETER (IC71132UG/ 30805056) FOR OCCLUSION SITE AT THE M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA). THERE WAS UNDERLYING ICAD (INTRACRANIAL ATHEROSCLEROTIC DISEASE) AT THE OCCLUSION SITES. THE PRE-PASS MTICI SCORE WAS 0. THE FIRST PASS WAS MADE USING EMBOTRAP DEVICE WHICH RESULTED IN A MTICI SCORE OF 2C, WITH CLOT RETRIEVAL IN THE STENT-RETRIEVER. DURING THE PROCEDURE A GUIDEWIRE WAS U

  Patient problems: Obstruction/Occlusion

  MAUDE report 22458438 ↗
• MalfunctionJun 17, 2025Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING A MECHANICAL THROMBECTOMY, THE DELIVERY WIRE DISTAL PART OF AN EMBOTRAP III 5 MM X 37 MM (ET307537, 24L105AV) WAS KINKED BEFORE THE DELIVERY WIRE WENT INTO THE SHEATH. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22230920 ↗
• MalfunctionJun 13, 2025Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE TARGETING AN OCCLUSION IN THE MIDDLE CEREBRAL ARTERY (MCA) IN A PATIENT WITH A CEREBRAL INFARCTION, THE DEVICES WERE ALL USED IN ACCORDANCE WITH THEIR RESPECTIVE INSTRUCTIONS FOR USE (IFUS). WHEN THE 5MM X 37MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309537 / 24H006AV) WAS INSERTED INTO THE CONCOMITANT TREVO TRAK® 21 MICROCATHETER (STRYKER) AFTER THE LESION WAS CROSSED, A STRONG RESISTANCE WAS FELT UN THE MICROCATHETER. CONTINUOUS FLUSH WAS REPORTEDLY MAINTAINED. THE PHYSICIAN REMOVED THE DEVICES FROM THE PATIENT¿S ANATOMY. UPON CHECKING THE EMBOTRAP AND THE MICROCATHETER, THERE WERE NO VISIBLE DAMAGES NOTED, AND THE CAUSE OF THE ISSUE COULD NOT BE IDENTIFIED. THE EMBOTRAP AND THE MICROCATHETER WERE REPLACED AND THE REPLACEMENT DEVICES WERE USED WITHOUT ANY ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 10-JUN-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE REPORTED ISSUE OCCURRED ON THE DEVICE¿S FIRST PASS. ON 12-JUN-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE REPLACEMENT WAS ANOTHER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204075 ↗
• InjuryJun 10, 2025Adverse 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 37 MM (ET309537/ 25A211AV) WAS USED FOR A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION AT THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. THE PROCEDURE WAS PERFORMED BY COMBINED TECHNIQUE WITH USING THE EMBOTRAP III AND REACT CATHETER (MEDTRONIC). RECANALIZATION WAS ACHIEVED AND THE PROCEDURE WAS COMPLETED. HOWEVER, A MASSIVE HEMORRHAGE WAS CONFIRMED AFTER THE PROCEDURE AND TREATMENT FOR THE CEREBRAL HEMORRHAGE WAS PERFORMED. THE PHYSICIAN COMMENTED THAT HE WAS ABLE TO RETRIEVE THE THROMBUS WITHOUT FEELING ANY RETRIEVAL RESISTANCE DURING THE PROCEDURE. THE CAUSE, INCLUDING ANY RELATION TO THE PRODUCT, IS UNKNOWN. POST-PROCEDURE CHANGES IN THE PATIENT WERE REPORTED AS, ¿THE PATIENT IS ON A POOR PROGNOSIS. THE PATIENT HAS BEEN HOSPITALIZED.¿ CONTINUOUS FLUSH WAS UNKNOWN. ANOTHER CONCOMITANT DEVICE WAS A PHENOM MICROCATHETER (MEDTRONIC). THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF MIDDLE CEREBRAL ARTERY M1 TO TREAT CEREBRAL INFARCTION. THE DEVICES WERE USED ACCORDING TO IFU. THE PROCEDURE WAS PERFORMED BY COMBINED TECHNIQUE WITH USING THE EMBOTRAP III AND REA

  Patient problems: Intracranial Hemorrhage; Perforation of Vessels; Vasoconstriction

  MAUDE report 22176934 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE EXCELLENT STUDY (B)(6), A PATIENT OF UNKNOWN AGE, SEX, AND MEDICAL HISTORY (SUBJECT (B)(6) PRESENTED WITH AN UNKNOWN STROKE TYPE ON AN UNKNOWN DATE. AT THE TIME OF THIS REVIEW, NO INFORMATION OTHER THAN THE ADVERSE EVENT, HAS BEEN ENTERED INTO THE CLINICAL DATABASE, THE CRF. ON (B)(6) 2023, THE PATIENT EXPERIENCED THE ADVERSE EVENT OF ¿INTRACRANIAL HEMORRHAGE,¿ WHICH BECAME KNOWN TO THE SITE ON THE SAME DAY AND TO THE SPONSOR ON (B)(6) 2023. THE PRINCIPAL INVESTIGATOR (PI) ASSESSED THE EVENT AS A SERIOUS, SEVERE ADVERSE EVENT RESULTING IN SERIOUS DETERIORATION OF HEALTH AND PERMANENT IMPAIRMENT, AND AS NOT RELATED TO THE STUDY DEVICE, NOT RELATED TO THE LARGE BORE CATHETER, AND NOT RELATED TO THE PRIMARY SURGICAL PROCEDURE. THIS EVENT REQUIRED A SURGICAL INTERVENTION, ¿REMOVAL OF HEMATOMA.¿ THE OUTCOME IS RECORDED AS ¿RECOVERED/RESOLVED,¿ WITH AN END DATE OF (B)(6) 2023. NO FURTHER INFORMATION WAS MADE AVAILABLE AT THE TIME OF THIS REVIEW. ADDITIONAL INFORMATION WAS RECEIVED ON 08-MAY-2025. SUMMARY: A CLINICAL EVENT COMMITTEE (CEC) ADJUDICATION FOR THE ADVERSE EVENT OF ¿INTRACRANIAL HEMORRHAGE (LT PUTAMINAL HEMORRHAGE)¿ WAS RECEIVED. THE CEC ADJUDICATED EVENT TE

  Patient problems: Intracranial Hemorrhage

  MAUDE report 22108356 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA A HEALTH AUTHORITY, THAT AN EMBOGUARD 87, 95 CM (BG8795U/ 9482253) AND AN EMBOTRAP III 5 MM X 37 MM (ET309537/ 25A111AV), WERE USED FOR A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION AT THE PROXIMAL M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) FOR AN ACUTE ISCHEMIC STROKE. DURING THE PROCEDURE, THE USER REPORTED A KINK/BEND OF THE EMBOGUARD CATHETER (BODY/SHAFT) WHILE IN PATIENT. ADDITIONALLY, A DISTAL EMBOLIZATION OF ORIGINAL THROMBUS TO THE M2 SEGMENT OF THE MCA OCCURRED WHILE USING AN APRO ASPIRATION CATHETER (MEDTRONIC) AND THE EMBOTRAP STENT-RETRIEVER. THE THROMBOEMBOLISM WAS RETRIEVED USING THE EMBOTRAP DEVICE AND A RED62 ASPIRATION CATHETER (PENUMBRA). FINAL ANGIOGRAPHY CONFIRMED COMPLETE RECANALIZATION, AND THE PROCEDURE WAS COMPLETED. NO NEGATIVE IMPACT TO THE PATIENT WAS REPORTED. IT WAS NOTED THE VESSELS (INCLUDING ABDOMEN) WERE SEVERELY TORTUOUS. ¿THE PHYSICIAN COMMENTED THAT WHEN THE EMBOGUARD WAS FIRST ADVANCED, THERE WERE NO ISSUES. HOWEVER, DUE TO PROBLEMS WITH ANOTHER DEVICE (PRESUMABLY APRO), THE EMBOGUARD BECAME NECESSARY TO BE REINSERTED. IT IS BELIEVED THAT A KINK OCCURRED WHEN THE EMBOGUARD WAS TEMPORARILY WITHDRAWN. THE PHYSI

  Patient problems: Thromboembolism

  MAUDE report 22073682 ↗
• MalfunctionApr 28, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT AN EMBOTRAP III 5 MM X 37 MM (ET309537/ 23K200AV) WAS USED FOR A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION FROM THE INTERNAL CAROTID ARTERY (ICA) TO THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) FOR AN ACUTE ISCHEMIC STROKE. DURING THE PROCEDURE, THE USER EXPERIENCED WITHDRAWAL DIFFICULTY INTO THE MICROCATHETER (INABILITY). AS A RESULT, THE PHYSICIAN WITHDREW THE EMBOTRAP III INTO THE CAT6 INTERMEDIATE CATHETER (PENUMBRA). THE WHOLE SYSTEM WAS REMOVED FROM THE PATIENT'S BODY AS A SINGLE UNIT. THE PHYSICIAN OPTED TO CANCEL THE PROCEDURE WITHOUT REMOVING THE THROMBUS SINCE THE VESSEL WAS EXTREMELY TORTUOUS, AND THE THROMBUS WAS VERY HARD; HE CONSIDERED FORCIBLY RETRIEVING A VERY HARD THROMBUS WOULD POSE A HIGH RISK FOR BLEEDING COMPLICATIONS. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICES WERE TRAK MICROCATHETER (STRYKER) AND A CAT6 INTERMEDIATE CATHETER. THE EVENT WAS REPORTED AS SUCH, ¿THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF INTERNAL CAROTID ARTERY - MIDDLE CEREBRAL ARTERY M1 OCCLUSION TO TREAT ACUTE CEREBRAL INFARCTION. THE DEVICE WAS USED ACCORDING TO I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918474 ↗
• InjuryApr 21, 2025Lack of Effect; Lack of Effect

  IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT AN EMBOTRAP III 5 MM X 37 MM (ET309537/ 24H197AV) WAS USED FOR A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION AT THE DISTAL M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING COMBINED TECHNIQUE. DURING THE PROCEDURE, THE EMBOTRAP III WAS USED FOR THREE PASSES, HOWEVER, RESIDUAL THROMBUS REMAINED. THE EMBOTRAP III DEVICE WAS EXCHANGED WITH A TREVO STENT-RETRIEVER (STRYKER) FOR THE FOURTH PASS AND THE CLOT WAS RETRIEVED. HOWEVER, A DISSECTION WAS OBSERVED AT INTERNAL CAROTID SEGMENT; THE EXACT TIMING OF THE EVENT WAS UNKNOWN. IT IS UNKNOWN OF A MEDICAL/SURGICAL TREATMENT WAS PERFORMED FOR THE DISSECTION. THE PATIENT¿S CURRENT STATUS IS ALSO UNKNOWN. THE PHYSICIAN ASSESSED THAT THERE WAS A CAUSAL RELATIONSHIP BETWEEN THIS EVENT AND THE PRODUCT. THE PHYSICIAN FURTHER COMMENTED HE COULD NOT UNDERSTAND WHY THE DISSECTION OCCURRED. IT IS NOTED THAT IT TENDS TO OCCUR IN RELATIVELY YOUNG FEMALE PATIENTS WITH FLEXIBLE VESSELS, WHICH MAY BE ONE POTENTIAL CAUSE. ALSO, HE BELIEVES HIGH NUMBER OF PASSES IS A POTENTIAL CAUSE OF THIS EVENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICES ARE OPTIMO BALLOON CATHETER (TOKAI MEDICA

  Patient problems: Vascular Dissection

  MAUDE report 21872852 ↗
• InjuryMar 4, 2025Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE TARGETING AN OCCLUSION IN THE INFERIOR M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) TO TREAT TROUSSEAU SYNDROME, AFTER FOUR (4) PASSES WERE MADE USING A 3MM X 20MM SOLITAIRE¿ REVASCULARIZATION DEVICE (MEDTRONIC), A 5MM X 37MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309537 / LOT# UNKNOWN) WAS USED. IT THEN REPORTED THAT DURING TRACTION OF THE EMBOTRAP III DEVICE, HEMORRHAGE OCCURRED. IT IS NOT KNOWN IF CONTINUOUS FLUSH WAS MAINTAINED. ADDITIONAL DETAILS RELATED TO THE REPORTED EVENT ARE TO BE CONFIRMED. ON 25-FEB-2025, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT NO IMAGES / ANGIOGRAPHS ARE AVAILABLE FOR REVIEW. ALL ADDITIONAL INFORMATION REQUESTED WILL BE MADE AVAILABLE WHEN THEY ARE OBTAINED.

  Patient problems: Intracranial Hemorrhage; Perforation of Vessels

  MAUDE report 21520993 ↗
• InjuryFeb 19, 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 TARGETING AN OCCLUSION IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY, ALL DEVICES WERE USED IN ACCORDANCE WITH THEIR RESPECTIVE INSTRUCTIONS FOR USE (IFUS) WITH CONTINUOUS FLUSH MAINTAINED DURING THE PROCEDURE. THE 5MM X 37MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309537 / 24G083AV), AN AXS VECTA 46 INTERMEDIATE CATHETER (STRYKER), 8F OPTIMO GUIDING CATHETER (TOKAI MEDICAL PRODUCTS), AND A PHENOM¿ MICROCATHETER (MEDTRONIC) WERE USED. IT WAS REPORTED THAT ALTHOUGH THE DIAMETER OF THE M2 SEGMENT WAS NOT MEASURED, THE VESSEL WAS STRAIGHT AND THE AXS VECTA 46 INTERMEDIATE CATHETER COULD BE ADVANCED, THEREFORE THE THROMBECTOMY PROCEDURE WAS PERFORMED USING THE CAPTIVE TECHNIQUE. THERE WAS NO RESISTANCE DURING THE WITHDRAWAL OF THE EMBOTRAP III DEVICE, BUT IT WAS CONFIRMED THAT THE VESSEL ¿APPEARED TO BE STRAIGHTENED.¿ VESSEL RECANALIZATION WAS ACHIEVED AFTER THE FIRST PASS, BUT BLEEDING WAS CONFIRMED VIA ANGIOGRAPHY. AFTER THE THROMBECTOMY, THE PATIENT UNDERWENT A CRANIOTOMY TO REMOVE THE HEMATOMA. THE PROGNOSIS FOR THE PATIENT WAS DEEMED TO BE GOOD. ON 17-FEB-2025, ADDITIONAL INFORMATION WAS RECEIV

  Patient problems: Intracranial Hemorrhage; Perforation of Vessels

  MAUDE report 21413870 ↗
• MalfunctionFeb 3, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT AN EMBOTRAP III 5 MM X 37 MM (ET309537/ 24H006AV) WAS USED FOR A THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION FROM THE DISTAL M1 TO M2 SEGMENTS OF THE MIDDLE CEREBRAL ARTERY (MCA). DURING THE PROCEDURE, THE USER REPORTED WITHDRAWAL DIFFICULTY OF THE EMBOTRAP DEVICE INTO THE MICROCATHETER -UNABLE TO. ULTIMATELY, RED62 ASPIRATION CATHETER (PENUMBRA) WAS ADVANCED TO THE M2 SEGMENT, AND THE THROMBUS WAS RETRIEVED BY COMBINED TECHNIQUE. M2 INFERIOR WAS CONFIRMED TO BE RECANALIZED BY THE FINAL ANGIOGRAPHY, BUT M2 SUPERIOR WAS STILL OCCLUDED AND THROMBECTOMY WAS NOT PERFORMED ON THE SUPERIOR AND THE PROCEDURE WAS TERMINATED. THREE DAYS AFTER THE PROCEDURE, A SUBARACHNOID HEMORRHAGE (SAH) OCCURRED. THE PHYSICIAN FURTHER COMMENTED, ¿SAH WAS NOT CAUSED BY THE DEVICE.¿ IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS MAINTAINED. OTHER CONCOMITANT DEVICES ARE UNKNOWN. THE EVENT WAS REPORTED AS SUCH, ¿THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF MIDDLE CEREBRAL ARTERY M1D TO M2. AFTER GUIDEWIRE AND MICROCATHETER WERE PLACED INTO M2 INFERIOR, THE EMBOTRAP III WAS DEPLOYED AT M2D. M1D HAD SEVERE TORTUOUS LIKE RUNNING DOWNWARD. WHEN A RED62 WAS PLACED AT

  Patient problems: Pain

  MAUDE report 21295007 ↗