EkoSonic® 6779-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00858593006134), received between Feb 22, 2017 and May 11, 2026 — classified as 4 deaths, 20 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (12 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 18, 2026.

Recalls naming this device

1. May 25, 2022Class IIOpen, Classified

   Product may be mislabeled.

   Z-1492-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2026Break; Electrical /Electronic Property Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A DEVICE BREAK OCCURRED AND ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE AN UNRETRIEVED DEVICE FRAGMENT. ON (B)(6) 2026, A 106X12CM EKOSONIC DEVICE WAS SELECTED FOR THE TREATMENT OF A UNILATERAL PULMONARY EMBOLISM (PE). DURING THERAPY INITIATION (RUNTIME 00:00), AN E322 ERROR WAS DETECTED ON CHANNEL A. THE DEVICE OPERATED WITH NORMAL SALINE COOLANT AT 35 ML/HR AND TISSUE PLASMINOGEN ACTIVATOR (TPA) AT 1 MG/HR (31.2 ML/HR). INSERTION WAS REPORTED AS UNCOMPLICATED, AND VASCULAR ANATOMY WAS NOT TORTUOUS. TROUBLESHOOTING STEPS WERE UNDERTAKEN, BUT THE ALARM PERSISTED. RESOLUTION WAS ACHIEVED BY REPLACING THE ULTRASONIC CORE WIRE AND PERFORMING A HARD REBOOT. FOLLOWING THESE INTERVENTIONS, THE SYSTEM RESUMED NORMAL FUNCTION WITHOUT FURTHER ALARMS. NO PATIENT COMPLICATIONS OCCURRED DURING THE EVENT, AND THE PATIENT REMAINED IN GOOD CONDITION POST-PROCEDURE. ON (B)(6) 2026, FOLLOW-UP IMAGING REVEALED AN UNIDENTIFIED OBJECT WITHIN THE PATIENT'S VASCULATURE. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR RETRIEVAL. SUBSEQUENT PHYSICIAN EVALUATION IDENTIFIED THE OBJECT AS AN UNRETRIEVED DEVICE FRAGMENT (UDF) FROM THE EKOSONIC DEVICE USED IN THE (B)(6) PROCEDURE. THE UD

  Patient problems: Foreign Body In Patient

  MAUDE report 25140021 ↗
• MalfunctionAug 19, 2025Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE EKOS CATHETER WAS LEAKING AT THE DEVICE HUB OR MANIFOLD. AN EKOSONIC DEVICE WAS SELECTED FOR USE TO TREAT A BILATERAL PULMONARY EMBOLISM. TWO EKOS DEVICES WERE PLACED LATE IN THE EVENING. THE FOLLOWING MORNING, STAFF OBSERVED THAT ONE OF THE EKOS CATHETERS WAS LEAKING. THE LEAK WAS NOT REPORTED AS BEING CLINICALLY SIGNIFICANT. THE LEAK DID NOT IMPACT THE ADMINISTRATION OF ULTRASOUND OR LYTIC, AND THROMBUS RESOLUTION WAS ACHIEVED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WAS A HOLE ON A PORTION OF THE INFUSION CATHETER THAT WOULD HAVE ENTERED THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22843838 ↗
• MalfunctionMay 14, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE. THIS 106X12CM EKOSONIC CATHETER WAS SELECTED FOR USE DURING A BILATERAL PULMONARY EMBOLISM THROMBOLYSIS PROCEDURE. AFTER THROMBOLYSIS WAS COMPLETE, THE EKOS CATHETERS WERE BEING REMOVED, AND THE FIRST CATHETER WAS REMOVED WITHOUT INCIDENT. THE SECOND CATHETER WAS VERY DIFFICULT TO MOVE AND WAS NOTED TO BE STUCK. THE PHYSICIAN INCREASED THE PULLING PRESSURE SLIGHTLY, BUT THE PATIENT BEGAN TO COMPLAIN OF CHEST PAIN AND A PULLING FEELING IN THE CHEST AREA. THE ULTRASOUND CORE WIRE WAS REMOVED AND THE EKOS INFUSION CATHETER WAS FLUSHED BEFORE TRYING TO PULL AND REMOVE THE CATHETER AGAIN. THE PHYSICIAN INCREASED THE PULLING FORCE, THE CATHETER WAS REMOVED, AND THERE WERE NO PHYSICAL DEFECTS OBSERVED WITH THE CATHETER. THE PATIENT WAS NOTED TO BE DOING FINE AND WAS LATER DISCHARGED FROM THE HOSPITAL.

  Patient problems: Chest Pain

  MAUDE report 22018241 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT EXPERIENCED RIGHT SIDED INGUINAL HEMATOMA WITH SCROTAL INVOLVEMENT REQUIRING PROLONGED HOSPITALIZATION AND MEDICATION. ON (B)(6) 2025, SUBJECT WAS RANDOMIZED TO THE STUDY. ANTICOAGULATION AND EKOS INDEX PROCEDURE WERE PERFORMED ON THE SAME DAY. TWO EKOS DEVICES WERE SUCCESSFULLY PLACED IN THE RIGHT PULMONARY ARTERY AND LEFT PULMONARY ARTERY. THERAPY WAS INITIATED VIA THE EKOS DEVICES AT A RATE OF 2MG/HR FOR A TOTAL DOSE OF 7 MG ACROSS BOTH CATHETERS ON SAME DAY. ON (B)(6) 2025, THE SUBJECT WAS NOTED TO HAVE INCREASING TENDERNESS AND HARD SWELLING AROUND RIGHT GROIN REGION WHERE THE VENOUS CATHETER SITE WAS ACCESSED. SUBJECT WAS ALSO NOTED TO HAVE INCREASED SWELLING AND PURPLE DISCOLORATION THAT WORSENED OVER A DAY. A CT OF ABDOMINAL AND PELVIS WAS PERFORMED WHICH REVEALED, SMALL FOCI OF ACTIVE BLEEDING IN THE SUBCUTANEOUS TISSUES OF THE RIGHT GROIN, ADJACENT RIGHT INGUINAL HEMATOMA EXTENDS INTO THE RIGHT SCROTUM AND TOWARDS THE RIGHT FLANK. BILATERAL CENTRAL AND SEGMENTAL PULMONARY EMBOLI WITH OVERALL DECREASED CLOT BURDEN WHEN COMPARED TO (B)(6) 2025. THE BLEED WAS DETERMINED TO BE VENOUS IN ORIGIN AND SHOULD RESPOND TO PRESSURE. APIXABAN WAS START

  Patient problems: Extravasation; Hematoma; Swelling/ Edema

  MAUDE report 21638098 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HI-PEITHO CLINICAL STUDY. IT WAS REPORTED THAT ISCHEMIC CEREBROVASCULAR ACCIDENT (CVA) OCCURRED, REQUIRING INTERVENTION. ON (B)(6) 2024, THE SUBJECT UNDERWENT TREATMENT WITH STUDY DEVICE: EKOSONIC ENDOVASCULAR DEVICE, 106X12CM. TWO EKOS CATHETERS WERE SUCCESSFULLY PLACED, ONE IN THE RIGHT LOWER LOBAR ARTERY AND ONE IN THE LEFT LOWER LOBAR ARTERY. THERAPY WAS INITIATED VIA THE EKOS DEVICE AT A RATE OF 2MG/HR FOR A TOTAL DOSE OF 7 MG ACROSS BOTH THE CATHETERS ON THE SAME DAY. ON (B)(6) 2024, THE SUBJECT WAS DIAGNOSED WITH ISCHEMIC CEREBROVASCULAR ACCIDENT (CVA). THE EVENT LED TO PROLONGATION OF HOSPITALIZATION AND INTRA-ARTERIAL THERAPY INTERVENTION.

  Patient problems: Ischemia Stroke

  MAUDE report 21126401 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ISCHEMIC CEREBROVASCULAR ACCIDENT (CVA) OCCURRED, REQUIRING INTERVENTION. ON (B)(6) 2024, THE SUBJECT UNDERWENT TREATMENT WITH STUDY DEVICE: EKOSONIC ENDOVASCULAR DEVICE, 106X12CM. TWO EKOS CATHETERS WERE SUCCESSFULLY PLACED, ONE IN THE RIGHT LOWER LOBAR ARTERY AND ONE IN THE LEFT LOWER LOBAR ARTERY. THERAPY WAS INITIATED VIA THE EKOS DEVICE AT A RATE OF 2MG/HR FOR A TOTAL DOSE OF 7 MG ACROSS BOTH THE CATHETERS ON THE SAME DAY. ON 17-DEC-2024, THE SUBJECT WAS DIAGNOSED WITH ISCHEMIC CEREBROVASCULAR ACCIDENT (CVA). THE EVENT LED TO PROLONGATION OF HOSPITALIZATION AND INTRA-ARTERIAL THERAPY INTERVENTION.IT WAS FURTHER REPORTED THAT ON (B)(6) 2024, THE EKOS CATHETERS WERE SUCCESSFULLY PLACED IN THE RIGHT FEMORAL VEIN, RIGHT LOWER LOBAR ARTERY AND LEFT LOWER LOBAR ARTERY. IN THE CONTEXT OF THE STUDY, THE PATIENT RECEIVED TREATMENT WITH EKOS AND ANTICOAGULATION USING HEPARIN. ON 17-DEC-2024, THE SUBJECT DEVELOPED ACUTE WORSENING OF NEUROLOGICAL FUNCTION, FOR WHICH CEREBRAL COMPUTED TOMOGRAPHY (CT) WAS PERFORMED. THIS SHOWED A M1 CLOT IN THE LEFT MIDDLE CEREBRAL ARTERY AREA. THERE WERE ALSO SIGNS OF OCCLUSION AND CLOTS IN THE LEFT COMMON CAROTID (LCC) AND INTERNAL CA

  Patient problems: Ischemia Stroke

  MAUDE report 21126352 ↗
• MalfunctionOct 3, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THERE WAS A DRUG OCCLUSION. AN EKOSONIC ENDOVASCULAR DEVICE, 106X12CM WAS SELECTED FOR USE IN A BILATERAL THROMBOLYSIS PROCEDURE TO TREAT A PULMONARY EMBOLISM. THE EKOS DEVICE WAS PLACED IN THE LEFT PULMONARY ARTERY. DURING THE PROCEDURE, THERE WAS AN OCCLUSION IN THE DRUG LUMEN OF THE EKOS INFUSION CATHETER. AS A RESULT, EKOS THERAPY WAS DISCONTINUED WITH THIS DEVICE. THERE WAS NO REPORTED IMPACT TO THE PATIENT, AND THE PATIENT WAS REPORTED TO BE UNHARMED AS A RESULT OF THE DEVICE DEFICIENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20360347 ↗
• MalfunctionSep 5, 2024Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT THERE WAS A DRUG LEAK. A 106X12CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR USE IN A BILATERAL PULMONARY EMBOLISM CASE. AFTER 11 OF THE 12 HOURS OF ORDERED THERAPY TIME, IT WAS OBSERVED THAT THE DRUG LUER HAD BLOOD BACKING UP INTO IT, AND THERE WAS SMALL HOLE IN THE LUER LEAKING TPA. THE PHYSICIAN DECIDED TO PULL THE CATHETER. THE PATIENT DID WELL. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20145661 ↗
• InjuryMay 22, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT AN ERROR CODE WAS OBSERVED, RESULTING IN THE REPLACEMENT OF THE CATHETER. THIS 106X12CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR USE IN A BILATERAL PERIPHERAL ARTERIAL OBSTRUCTION PROCEDURE. AN E311 ERROR OCCURRED ON CHANNEL B DURING TREATMENT IN THE INTENSIVE CARE UNIT. THE PATIENT WAS BROUGHT BACK TO THE CATHETERIZATION LABORATORY TO REPLACE BOTH IMPLANTED CATHETERS. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19377260 ↗
• MalfunctionDec 22, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THERE WAS A DRUG DELIVERY ISSUE. A 106X12CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR USE IN A PROCEDURE TO TREAT A PULMONARY EMBOLISM. DURING PREPARATION, IT WAS FOUND THE TPA PART OF THE CATHETER WAS NOT WORKING. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18388918 ↗
• MalfunctionDec 7, 2023Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01 DEC 2023. THE RETURNED DEVICE EVALUATION REVEALED THERE WAS A FRACTURE. IT WAS REPORTED THAT THIS CATHETER WOULD NOT CROSS/TRACK. THIS 106X12CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR USE IN A PULMONARY EMBOLISM PROCEDURE. DURING THE PROCEDURE, THE CATHETER WOULD NOT CROSS OR TRACK. THE PROCEDURE WAS COMPLETED WITH A NEW CATHETER AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18287994 ↗
• MalfunctionOct 2, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE LYTIC THERAPY WOULD NOT INFUSE. DURING A BILATERAL EKOS CASE, TWO EKOS+ DEVICES WERE INSERTED INTO THE PATIENT. WHEN THE EKOS+ KIT 106CM 12 CM WAS HOOKED UP TO INFUSE LYTIC, THE DRUG WOULD NOT INFUSE. THE DRUG LINE WAS ASPIRATED IN AN ATTEMPT TO TROUBLESHOOT THE ISSUE. THE EKOS+ DEVICE WAS REPLACED WITH AN EKOSONIC ENDOVASCULAR DEVICE, 106X12CM TO TROUBLESHOOT THE ISSUE, BUT THE NEW EKOSONIC DEVICE WOULD NOT INFUSE LYTIC. ONCE AGAIN, THE DRUG LINE WAS ASPIRATED IN AN ATTEMPT TO TROUBLESHOOT THE ISSUE. AS A RESULT OF THE DEVICE MALFUNCTION, THE PHYSICIAN ELECTED TO REMOVE THE EKOSONIC ENDOVASCULAR DEVICE, AND THE PATIENT WAS TRANSFERRED TO THE ICU WITH ONLY ONE EKOS+ DEVICE IN PLACE. IT WAS UNKNOWN WHETHER THE PATIENT RECEIVED THE CORRECT DOSE OF LYTIC THERAPY. HOWEVER, THERE WAS NO REPORTED UNDESIRABLE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17856955 ↗
• InjuryAug 31, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPERTENSION. AN EKOSONIC ENDOVASCULAR DEVICE, 106X12CM WAS SELECTED FOR USE IN A BILATERAL PULMONARY EMBOLISM CASE. THERE WAS AN E322 ALARM ON CHANNEL B OF THE CONTROL UNIT. CHANNEL A WAS WORKING, AND ALL MEDICATIONS WERE INFUSING WITHOUT ISSUE. CHANNEL B WAS RESTARTED, AND THE ISSUE WAS RESOLVED. HOWEVER, THE PATIENT WAS REPORTED TO BE HYPERTENSIVE, AND IT WAS UNDETERMINED WHETHER THE HYPERTENSION WAS A RESULT OF THE EKOS DEVICE OR PROCEDURE. THE REMAINDER OF EKOS THERAPY WAS COMPLETED WITHOUT FURTHER ISSUE.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 17662222 ↗
• InjuryJul 31, 2023Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  HI-PEITHO CLINICAL STUDY. IT WAS REPORTED THAT THE SUBJECT EXPERIENCED MODERATE BLEEDING AND HEMATOMA AS A RESULT OF THE INDEX PROCEDURE. ON (B)(6) 2023, THE SUBJECT UNDERWENT TREATMENT WITH STUDY DEVICE USING ULTRASOUND GUIDANCE. TWO EKOS CATHETERS WERE SUCCESSFULLY PLACED IN BOTH THE RIGHT LOWER LOBAR ARTERY AND THE LEFT LOWER LOBAR ARTERY. THERAPY WAS INITIATED VIA THE EKOS DEVICES AT A RATE OF 2 MG/HR FOR A TOTAL DOSE OF 1 MG ACROSS BOTH CATHETERS ON SAME DAY. ON (B)(6) 2023, THE SUBJECT INITIATED TREATMENT OF ENOXAPARIN 8000 IU ONCE A DAY VIA SUBCUTANEOUS ROUTE. ON THE SAME DAY, THE SUBJECT WAS NOTED WITH BLEEDING FROM INTRODUCER SHEATH SITE DURING ADMINISTRATION OF TISSUE PLASMINOGEN ACTIVATOR (TPA) AND ULTRASOUND. IN RESPONSE, UNFRACTIONATED HEPARIN WAS STOPPED, AND SUBJECT WAS ADJUSTED ONTO THERAPEUTIC DOSE OF ENOXAPARIN. THE SEVERITY OF EVENT WAS CONSIDERED TO BE MODERATE. TPA AND ULTRASOUND WERE STOPPED AT 20:35 AND THE CATHETER WAS REMOVED. COMPRESSION OF INJECTION SITE AND SIZE OF HEMATOMA WAS DOCUMENTED. ON (B)(6) 2023, THE OUTCOME OF THE EVENT WAS CONSIDERED RESOLVED. IT WAS FURTHER REPORTED THAT DURING THE INDEX PROCEDURE, BOTH THE CATHETERS WERE SUCCESSFULLY PLACED

  Patient problems: Chest Pain; Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17426318 ↗
• InjuryJul 31, 2023Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  HI-PEITHO CLINICAL STUDY: IT WAS REPORTED THAT THE SUBJECT EXPERIENCED MODERATE BLEEDING AND HEMATOMA AS A RESULT OF THE INDEX PROCEDURE. ON (B)(6) 2023, THE SUBJECT UNDERWENT TREATMENT WITH STUDY DEVICE USING ULTRASOUND GUIDANCE. TWO EKOS CATHETERS WERE SUCCESSFULLY PLACED IN BOTH THE RIGHT LOWER LOBAR ARTERY AND THE LEFT LOWER LOBAR ARTERY. THERAPY WAS INITIATED VIA THE EKOS DEVICES AT A RATE OF 2 MG/HR FOR A TOTAL DOSE OF 1 MG ACROSS BOTH CATHETERS ON SAME DAY. ON (B)(6) 2023, THE SUBJECT INITIATED TREATMENT OF ENOXAPARIN 8000 IU ONCE A DAY VIA SUBCUTANEOUS ROUTE. ON THE SAME DAY, THE SUBJECT WAS NOTED WITH BLEEDING FROM INTRODUCER SHEATH SITE DURING ADMINISTRATION OF TISSUE PLASMINOGEN ACTIVATOR (TPA) AND ULTRASOUND. IN RESPONSE, UNFRACTIONATED HEPARIN WAS STOPPED, AND SUBJECT WAS ADJUSTED ONTO THERAPEUTIC DOSE OF ENOXAPARIN. THE SEVERITY OF EVENT WAS CONSIDERED TO BE MODERATE. TPA AND ULTRASOUND WERE STOPPED AT 20:35 AND THE CATHETER WAS REMOVED. COMPRESSION OF INJECTION SITE AND SIZE OF HEMATOMA WAS DOCUMENTED. ON 03-JUL-2023, THE OUTCOME OF THE EVENT WAS CONSIDERED RESOLVED. IT WAS FURTHER REPORTED THAT DURING THE INDEX PROCEDURE, BOTH THE CATHETERS WERE SUCCESSFULLY PLACED

  Patient problems: Chest Pain; Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17426317 ↗
• InjuryApr 19, 2023Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT THERE WAS A LEAK IN THE DRUG LUMEN, AND THERAPY WAS DISCONTINUED PREMATURELY AS A RESULT. THE PATIENT WAS SENT TO A NEIGHBORING HOSPITAL FOR FURTHER TREATMENT. AN EKOSONIC ENDOVASCULAR DEVICE, 106X12CM WAS SELECTED FOR USE. FOLLOWING CATHETER PLACEMENT, THE PATIENT WAS IN THE PROCESS OF TREATMENT IN THE ICU. AFTER 12 HOURS OF A SCHEDULED 24-HOUR LYTIC TREATMENT, THERE WAS A LEAK OBSERVED IN THE DRUG LUMEN OUTSIDE OF THE PATIENT. IT WAS REPORTED THAT THE DRUG PORT ON THE OUTSIDE OF THE CATHETER HAD DETACHED. DUE TO THIS MALFUNCTION, THERAPY WAS DISCONTINUED PREMATURELY, AND THE PATIENT DID NOT RECEIVE THE INTENDED AMOUNT OF LYTIC. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR FURTHER TREATMENT. NO FURTHER PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16768609 ↗
• InjuryFeb 22, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED TO THE CATHETERIZATION LAB TO REPLACE THE CATHETER. AN EKOS ENDOVASCULAR DEVICE, 106X12CM WAS SELECTED FOR UNILATERAL USE. THE CATHETER WAS PLACED IN THE PULMONARY ARTERY, AT WHICH POINT LYSIS, COOLANT, AND ULTRASOUND WERE INITIATED. THE PATIENT WAS MOVED TO THE ICU FOR CONTINUED THERAPY. AFTER APPROXIMATELY 45 MINUTES, AN ERROR E311 WAS OBSERVED ON THE CONTROL UNIT (CU). TROUBLESHOOTING STEPS INCLUDED FLUSHING THE CATHETER, EXCHANGING THE CATHETER INTERFACE CABLE (CIC), AND CONNECTING THE CIC TO A DIFFERENT CU CHANNEL, NONE OF WHICH RESOLVED THE ERROR MESSAGE. CATHETER CONNECTIONS WERE CONFIRMED TO BE DRY WITH NO BENT PINS. AS TROUBLESHOOTING WAS UNSUCCESSFUL, THE PATIENT RETURNED TO THE CATHETERIZATION LAB AND THE EKOS ENDOVASCULAR DEVICE WAS REPLACED. FOLLOWING CATHETER REPLACEMENT, THE ERROR E311 WAS STILL OBSERVED ON THE CU. THERAPY WAS COMPLETED BY USING THE SECOND EKOS ENDOVASCULAR DEVICE AS A STANDARD INFUSION CATHETER WITHOUT THE USE OF ULTRASOUND. THE PROCEDURE OUTCOME WAS GOOD WITHOUT THE USE OF ULTRASOUND. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16424709 ↗
• MalfunctionJan 27, 2023Obstruction of Flow; Obstruction of Flow

  (B)(4) HI-PEITHO CLINICAL STUDY. IT WAS REPORTED THAT THERE WAS A LINE OCCLUSION DURING THE PROCEDURE. ON (B)(6) 2023, THE PATIENT WAS ENROLLED IN THE CLINICAL STUDY, AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. EKOSONIC ENDOVASCULAR DEVICES WERE USED IN CONJUNCTION WITH AN EKOS CONTROL SYSTEM 4.0. THE CATHETERS WERE USED WITHOUT THE USE OF ULTRASOUND. ONE EKOSONIC ENDOVASCULAR DEVICE WAS SUCCESSFULLY PLACED IN THE RIGHT PULMONARY ARTERY AND ONE EKOSONIC ENDOVASCULAR DEVICE WAS SUCCESSFULLY PLACED IN THE LEFT PULMONARY ARTERY. THERAPY WAS INITIATED AT A RATE OF 1 MG/HR FOR A TOTAL DOSE OF 2 MG ACROSS BOTH CATHETERS. THERE WAS A LINE OCCLUSION, AND THE PHYSICIAN WAS UNABLE TO DELIVER BOLUS. THE CATHETER WAS EXCHANGED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16259434 ↗
• MalfunctionDec 19, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE DRUG PORT WAS OCCLUDED. A 106X12CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR USE IN A PROCEDURE TO TREAT A PULMONARY EMBOLISM. AFTER A THERAPY RUN TIME OF 12 HOURS, THE EKOS CATHETER WAS BLOCKED TO SALINE IN THE COOLANT PORT. THE PHYSICIAN TRIED REMOVING THE CATHETER FROM THE PA FIVE TIMES AND WASHED IT, BUT THE CATHETER WAS STILL BLOCKED, AND SALINE FAILED TO ENTER INTO THE COOLANT PORT OF THE CATHETER. THE DRUG PORT WAS ALSO OCCLUDED, SO THE DEVICE WAS REMOVED. THE PROCEDURE CONTINUED WITH ONLY ONE CATHETER IN THE LEFT SIDE OF THE PA. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16005179 ↗
• MalfunctionNov 18, 2022Device Alarm System; Difficult to Remove; Device Alarm System; Difficult to Remove

  IT WAS REPORTED THAT THERE WAS REMOVAL DIFFICULTY. A 106X12CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR THE INDEX PROCEDURE. THE DEVICE WAS INSERTED AND HAD AIR BUBBLES IN THE DRUG LINE THAT HAD TO BE ASPIRATED, SO THE CATHETER WAS NOT ABLE TO BE FORWARD FLUSHED. ABOUT 30 MINUTES INTO THE THERAPY, WHILE THE PATIENT WAS BEING TRANSFERRED, AN OCCLUSION ALARM SOUNDED. AT THAT POINT, THE PATIENT WAS RETURNED TO THE TABLE TO PULL OUT THE INFUSION CATHETER TO REPLACE IT WITH A NEW ONE. AS THE PHYSICIAN WAS REMOVING THE CATHETER, HOWEVER, THE CATHETER KEPT "CATCHING" ON SOMETHING. THERE WAS A STRUGGLE TO REMOVE THE CATHETER. THE PHYSICIAN HAD TO PINCH THE WIRE WITH A HEMOSTAT TO HOLD IT IN PLACE WHILE PULLING THE INFUSION CATHETER BACK. THE CATHETER WAS ABLE TO BE REMOVED AND A NEW CATHETER PASSED OVER THE WIRE SMOOTHLY. THERE WERE NO FURTHER COMPLICATIONS. THE PATIENT WAS DOING WELL AND ULTIMATELY RECEIVED THE CORRECT DOSE OF LYTIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15825103 ↗
• InjuryNov 9, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE PATIENT HAD TO RETURN TO THE CATH LAB FOR CATHETER REPLACEMENT. TWO EKOSONIC ENDOVASCULAR DEVICES, 106X12CM WERE SELECTED FOR USE IN A CATHETER DIRECTED THROMBOLYSIS PROCEDURE TO TREAT A BILATERAL PULMONARY EMBOLISM ORIGINATING FROM A DEEP VEIN THROMBOSIS. THE 2 EKOS CATHETERS WERE PLACED WITH 8MG OF ACTLYASE ADMINISTERED ON EACH CATHETER OVER 24HRS. AFTER THE CATHETERS WERE PLACED, THE PATIENT WAS MOVED TO THE ICU. THE CU4.0 AND CIC WERE CONNECTED IN THE ICU. THE DEVICE KEPT GIVING AN E311 ERROR AFTER IT WAS CONNECTED TO THE 2 EKOS CATHETERS, 16 MINUTES AFTER ADMINISTERING TREATMENT ON THE FIRST SIDE THEN GAVE THE SAME ERROR ON OTHER SIDE ABOUT AN HOUR LATER. PRESSURES ON ALL INFUSION PUMPS WAS 900MG. INFUSION RATE OF DRUG PORT WAS 8.3ML/H THEN COOLANT AND SHEATH WERE INFUSING AT 41.66ML/H. THE CONTROL UNIT WAS SWAPPED FOR A NEW ONE, BUT IT STILL GAVE THE SAME ERROR. THE CICS WERE SWAPPED AROUND, AND NEW ONES WERE USED ON BOTH THE OLD AND NEW MACHINE, BUT THE SAME ERROR OCCURRED. THE ULTRASONIC CORE WAS EXCHANGED ON ONE OF THE CATHETERS IN THE ICU, BUT THE SAME ERROR OCCURRED. ULTIMATELY, THE PATIENT WAS BROUGHT BACK TO THE THEATRE TO EXCHANGE THE 5FR CATH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15763757 ↗
• InjuryJul 29, 2022Device Alarm System; Obstruction of Flow; Device Alarm System; Obstruction of Flow

  IT WAS REPORTED THAT A DOWN STREAM DRUG OCCLUSION OCCURRED REQUIRING ADDITIONAL INTERVENTION. TWO 106CM X12CM EKOSONIC ENDOVASCULAR CATHETERS WERE SELECTED FOR TREATMENT OF A PULMONARY EMBOLISM. THE PATIENT WAS BROUGHT FROM THE INTERVENTIONAL RADIOLOGY (IR) LAB TO THE INTENSIVE CARE UNIT (ICU) WITH THE CATHETERS PLACED BUT WITHOUT TPA INFUSING. WHEN THE CATHETERS CLOTTED THE PATIENT WAS TAKEN BACK TO THE IR LAB. ONE OF THE CATHETERS WAS REPLACED. THE SECOND CATHETER WAS REPOSITIONED AND THE PATIENT WAS RETURNED TO THE ICU. UPON THE PATIENT'S RETURN TO THE ICU, THERAPY WAS RESTARTED AND RUNNING WHEN AN ALARM INDICATING A DOWNSTREAM OCCLUSION ON BOTH DRUG LINES WAS RECEIVED. THE CATHETER WAS CHECKED FOR KINKS, CLOSED STOPCOCKS AND CLOSED ROLLER CLAMPS; THERE WERE NONE. INFUSION RATE AND PUMP PRESSURE WERE WITHIN THE RECOMMENDED RANGE. THE CATHETERS WERE CHECKED FOR COILS OR SUTURES; THERE WERE NONE. THE NURSE ATTEMPTED TO FLUSH THE CATHETERS BUT WAS UNSUCCESSFUL. THE CATHETER WAS PULLED BACK 1MM AND FLUSHING WAS REATTEMPTED BUT THE LINE WAS UNABLE TO BE FLUSHED DUE TO CLOTTING. THE PATIENT WAS WORSENING POSSIBLY DUE TO DELAY IN TREATMENT CAUSED BY THE CLOTTING OF THE CATHETERS. THE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15135616 ↗
• InjuryJul 29, 2022Device Alarm System; Obstruction of Flow; Device Alarm System; Obstruction of Flow

  IT WAS REPORTED THAT A DOWN STREAM DRUG OCCLUSION OCCURRED REQUIRING ADDITIONAL INTERVENTION. TWO 106CM X12CM EKOSONIC ENDOVASCULAR CATHETERS WERE SELECTED FOR TREATMENT OF A PULMONARY EMBOLISM. THE PATIENT WAS BROUGHT FROM THE INTERVENTIONAL RADIOLOGY (IR) LAB TO THE INTENSIVE CARE UNIT (ICU) WITH THE CATHETERS PLACED BUT WITHOUT TPA INFUSING. WHEN THE CATHETERS CLOTTED THE PATIENT WAS TAKEN BACK TO THE IR LAB. ONE OF THE CATHETERS WAS REPLACED. THE SECOND CATHETER WAS REPOSITIONED AND THE PATIENT WAS RETURNED TO THE ICU. UPON THE PATIENT'S RETURN TO THE ICU, THERAPY WAS RESTARTED AND RUNNING WHEN AN ALARM INDICATING A DOWNSTREAM OCCLUSION ON BOTH DRUG LINES WAS RECEIVED. THE CATHETER WAS CHECKED FOR KINKS, CLOSED STOPCOCKS AND CLOSED ROLLER CLAMPS; THERE WERE NONE. INFUSION RATE AND PUMP PRESSURE WERE WITHIN THE RECOMMENDED RANGE. THE CATHETERS WERE CHECKED FOR COILS OR SUTURES; THERE WERE NONE. THE NURSE ATTEMPTED TO FLUSH THE CATHETERS BUT WAS UNSUCCESSFUL. THE CATHETER WAS PULLED BACK 1MM AND FLUSHING WAS REATTEMPTED BUT THE LINE WAS UNABLE TO BE FLUSHED DUE TO CLOTTING. THE PATIENT WAS WORSENING POSSIBLY DUE TO DELAY IN TREATMENT CAUSED BY THE CLOTTING OF THE CATHETERS. THE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15135613 ↗
• MalfunctionJun 17, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THERE WAS A LABELING ISSUE. A 106X12CM EKOSONIC ENDOVASCULAR DEVICE (EKOS) WAS SELECTED FOR USE IN A PULMONARY EMBOLISM (PE) PROCEDURE. WHEN THE PHYSICIAN TRIED TO PLACE THE ULTRASONIC CORE WIRE IN THE PATIENT, IT WAS REALIZED THAT SOMETHING WAS WRONG. THE DEVICE WAS REMOVED FROM THE PATIENT AND WAS MEASURED. THE ULTRASONIC CORE WIRE MEASURED 135CM. THE DEVICE WAS EXCHANGED AND FOUND THE SECOND BOX HAD THE SAME ISSUE. THE DEVICE WAS THEN EXCHANGED AGAIN, AND TREATMENT PROCEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14733405 ↗
• MalfunctionJun 17, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THERE WAS A LABELING ISSUE A 106X12CM EKOSONIC ENDOVASCULAR DEVICE (EKOS) WAS SELECTED FOR USE IN A PULMONARY EMBOLISM (PE) PROCEDURE. WHEN THE PHYSICIAN TRIED TO PLACE THE ULTRASONIC CORE WIRE IN THE PATIENT, IT WAS REALIZED THAT SOMETHING WAS WRONG. THE DEVICE WAS REMOVED FROM THE PATIENT AND WAS MEASURED. THE ULTRASONIC CORE WIRE MEASURED 135CM. THE DEVICE WAS EXCHANGED AND FOUND THE SECOND BOX HAD THE SAME ISSUE. THE DEVICE WAS THEN EXCHANGED AGAIN, AND TREATMENT PROCEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14733238 ↗