EkoSonic® 6795-007Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00858593006318), received between Apr 11, 2017 and May 16, 2025 — classified as 15 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Break” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2025Output Problem; Output Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21APR2025. IT WAS REPORTED THAT ERROR MESSAGES OCCURRED. A 135X50CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR USE IN THE TREATMENT OF DEEP VEIN THROMBOSIS. WHEN IN THE INTERVENTIONAL RADIOLOGY (IR) SUITE, A DEVICE TEMPERATURE TOO HIGH ERROR MESSAGE OCCURRED, SO THE PT3B CONSOLE WAS SWAPPED OUT FOR ANOTHER ONE. THE PATIENT HAD JUST BEEN TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) WHEN IT WAS OBSERVED THAT THE PT3B WAS NOT RUNNING. WHEN STARTED, IT TOOK APPROXIMATELY FIVE MINUTES FOR THE SAME DEVICE TEMPERATURE TOO HIGH ERROR MESSAGE TO OCCUR AGAIN. TROUBLESHOOTING WAS UNSUCCESSFUL. THE DEVICE WAS POWERED DOWN FOR FIVE MINUTES, BUT UPON TURNING BACK ON AND STARTING THERAPY, AN ALL MSD GROUPS DISABLED ERROR MESSAGE APPEARED. TROUBLESHOOTING WAS AGAIN UNSUCCESSFUL, SO IT WAS DECIDED THAT THE PROCEDURE WOULD BE COMPLETED WITHOUT ULTRASOUND USING THE CATHETER AS A STANDARD DRIP INFUSION CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS REPORTED TO BE DOING WELL. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE ULTRASONIC CORE WAS SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038879 ↗
• MalfunctionJan 27, 2025Break; Break

  IT WAS REPORTED THAT THE ULTRASONIC CORE BROKE. A 135CM X 50CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR USE IN A RIGHT LOWER EXTREMITY ULTRASOUND-ACCELERATED THROMBOLYSIS PROCEDURE FOR DEEP VEIN THROMBOSIS (DVT). DURING THE PROCEDURE INSIDE THE BODY, WHILE ATTEMPTING TO REMOVE AND REPOSITION THE CATHETER INTO A BETTER LOCATION, THE ULTRASONIC CORE BROKE INTO TWO PIECES. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21242097 ↗
• InjuryJan 16, 2025Material Twisted/Bent; Output Problem; Material Twisted/Bent; Output Problem

  IT WAS REPORTED THAT UNPLANNED SEDATION OCCURRED. A 135CM X 50CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR USE IN A UNILATERAL CASE TO TREAT A PERIPHERAL ARTERIAL OCCLUSION (PAO) IN THE RIGHT LEG. AFTER 4HOURS AND 30 MINUTES OF THERAPY RUNTIME, THE EKOS HELPLINE WAS CALLED DUE TO AN E311 NO TRANSDUCER GROUPS ENABLED ALARM ON CHANNEL B. IT WAS ALSO REPORTED THAT THE PATIENT WOKE UP AGITATED, CONFUSED, AND UNCOOPERATIVE. THE PATIENT ATTEMPTED TO GET OUT OF BED AND WALK. THEREFORE, THE PATIENT WAS SEDATED. IN AN ATTEMPT TO TROUBLESHOOT THE ALARM, THE UNIT WAS RESET, AND CONNECTIONS WERE CHECKED. SWAPPING THE DEVICE TO CHANNEL A AND A HARD REBOOT WERE BOTH UNSUCCESSFUL. SINCE TROUBLESHOOTING WAS UNSUCCESSFUL, THE OPTIONS WERE TO RUN THE CATHETER AS A STANDARD DRIP CATHETER OR HAVE THE PHYSICIAN COME BACK TO EXCHANGE THE CATHETER. THE PATIENT WAS IN AN AGITATED SLUMBER. NO FURTHER COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE ULTRASONIC CORE WAS KINKED UPON INSERTION. THE PROCEDURE WAS COMPLETED USING THE CATHETER AS A STANDARD DRIP CATHETER. THE CLOT WAS RESOLVED, AND THE PATIENT WAS DISCHARGED.

  Patient problems: Confusion/ Disorientation

  MAUDE report 21173328 ↗
• MalfunctionJan 14, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS AN E311 ERROR DURING THE INITIAL PROCEDURE. AN EKOSONIC ENDOVASCULAR DEVICE, 135X50CM WAS SELECTED FOR USE IN A UNILATERAL THROMBECTOMY PROCEDURE. THE EKOS DEVICE WAS PREPPED AND DEPLOYED IN THE USUAL FASHION WITHOUT DIFFICULTY. THE CATHETER WAS PLACED AND HOOKED UP TO ALL INFUSING FLUIDS. UPON CONNECTION OF THE EKOS DEVICE TO THE EKOS CU 4.0 CONSOLE, THERE WAS AN E311 ERROR ON THE CONSOLE. MULTIPLE TROUBLESHOOTING ATTEMPTS WERE MADE, BUT THE ERROR PERSISTED. THE EKOS DEVICE WAS PLUGGED INTO A PT3B, WHICH EXPERIENCED AN ERROR AS WELL. THE EKOS DEVICE WAS EXCHANGED, AND THE ISSUE WAS RESOLVED. THERE WERE NO REPORTED PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE ULTRASONIC CORE (USC) WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21150041 ↗
• InjuryDec 11, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT THE PATIENT HAD TO RETURN TO THE CATH LAB FOR DEVICE EXCHANGE. AN EKOSONIC ENDOVASCULAR DEVICE, 135X50CM WAS SELECTED FOR USE. DURING THERAPY IN THE ICU, THERE WAS AN "ALL MSD GROUPS DISABLED" ALARM ON THE PT3B. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ALARM. THE PATIENT WAS RETURNED TO THE CATH LAB AND THE EKOS DEVICE WAS EXCHANGED. THE ERROR WAS RESOLVED AND EKOS THERAPY CONTINUED. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20907535 ↗
• MalfunctionOct 3, 2024Break; Difficult to Remove; Failure to Advance; Material Twisted/Bent; Break; Difficult to Remove; Failure to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT THE ULTRASONIC CORE BROKE. A 135X50CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR USE IN A THROMBOLYSIS PROCEDURE TO TREAT AN OCCLUDED SUPERFICIAL FEMORAL ARTERY (SFA). DURING PREPARATION, THE CATHETER WAS VIGOROUSLY FLUSHED, AND THE ULTRASONIC CORE WAS INSERTED INTO THE CATHETER, BUT IT BECAME STUCK. ADVANCING THE ULTRASONIC CORE WORE THROUGH THE CATHETER; IT BECAME KINKED. IT WAS VERY HARD TO PUSH, AND THEN VERY HARD TO PULL OUT. UPON PULLING THE ULTRASONIC CORE BACK, IT BROKE IN TWO. THE ULTRASONIC CORE WAS STICKING OUT OF THE CATHETER AND WAS GRASPED WITH A HEMOSTAT AND PULLED COMPLETELY AND FULLY OUT OF THE CATHETER. THE CATHETER WAS FULLY INTACT AND WAS SUCCESSFULLY REMOVED FROM PATIENT. THE PROCEDURE WAS COMPLETED WITH A GOOD OUTCOME USING A NON-BOSTON SCIENTIFIC INFUSION CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20360063 ↗
• MalfunctionSep 23, 2024Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 13SEP2024. THE RETURNED DEVICE EVALUATION REVEALED THE INFUSION CATHETER TUBING WAS SEVERED. IT WAS REPORTED THAT THE DEVICE LEAKED LIQUID DURING FLUSHING. DURING THE INITIAL PROCEDURE IN THE CATHETERIZATION LABORATORY, THIS 135X50CM EKOSONIC ENDOVASCULAR DEVICE WAS SUCCESSFULLY SET UP, THEN LEAKING WAS OBSERVED DURING FLUSHING. IT WAS UNKNOWN IF THE LIQUID WAS DRUG OR COOLANT. THE PROCEDURE WAS COMPLETED WITH ANOTHER EKOS DEVICE AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20283028 ↗
• InjurySep 20, 2024Break; Break

  IT WAS REPORTED THAT THE ULTRASONIC CORE (USC) FRACTURED WITHIN THE PATIENT, AND ADDITIONAL INTERVENTION WAS REQUIRED TO RETRIEVE THE DEVICE FRAGMENT. AN EKOSONIC ENDOVASCULAR DEVICE, 135X50CM WAS SELECTED FOR USE IN THE ARTERIAL THROMBOLYSIS PROCEDURE. DURING THE INITIAL PROCEDURE, THE INFUSION CATHETER (IC) WAS INSERTED WITHOUT ISSUE. WHEN THE USC WAS INSERTED INTO THE IC, THE TIP OF THE USC FRACTURED WITHIN THE IC. THE USC WAS REMOVED, AND THE FRACTURED TIP WAS REMOVED USING A PAIR OF MOSQUITO FORCEPS. THE USC WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20267324 ↗
• MalfunctionAug 20, 2024Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23JUL2024. A 135X50CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR USE. IT WAS OBSERVED THAT THE COOLANT LUER WAS CRACKED AND LEAKING. A SECOND CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE DRUG LUER WAS ALSO CRACKED AND LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20006374 ↗
• MalfunctionJul 9, 2024Material Integrity Problem; Output Problem; Material Integrity Problem; Output Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 28-JUN-2024. THE RETURNED DEVICE EVALUATION REVEALED A SEVERED ULTRASONIC CORE. IT WAS REPORTED THAT THIS 135X50CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR USE IN A BILATERAL DEEP VEIN THROMBOSIS PROCEDURE. AFTER PLACEMENT OF THE CATHETER, IT WAS NOTED THAT THE CATHETER WAS FORCEFULLY PUSHED INTO THE THROMBUS. THEN A RED W AND WHITE P ALARM WERE OBSERVED. THE CATHETER WAS LEFT IN PLACE AND THE PROCEDURE WAS COMPLETED USING THE CATHETER AS A STANDARD INFUSION CATHETER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19705684 ↗
• InjuryJul 9, 2024Leak/Splash; Material Integrity Problem; Leak/Splash; Material Integrity Problem

  IT WAS REPORTED THAT THERE WAS A DRUG LEAK, REQUIRING CATHETER REPLACEMENT. A 135X50CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED TO TREAT A SUPERFICIAL FEMORAL ARTERY THROMBUS POST-IMPELLA REMOVAL. THE CATHETER WAS PLACED AROUND NOON, AND LATER THAT EVENING, THE NURSE REPORTED THAT THE LEG WAS COMPLETELY COLORLESS AND HAD NO DISTAL PULSES. THEY WERE PALPABLE BEFORE PLACING THE EKOSONIC ENDOVASCULAR DEVICE. THE PATIENT WAS TAKEN BACK TO THE LAB, WHERE THEY FOUND THE DRUG LUMEN HAD A PINHOLE THAT HAD BEEN LEAKING THE ENTIRE TREATMENT TIME. THE PATIENT NEVER RECEIVED TPA FROM THE FIRST CATHETER. IT WAS REPLACED IN THE LAB WITH ANOTHER EKOSONIC ENDOVASCULAR DEVICE. THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: Ischemia

  MAUDE report 19700538 ↗
• MalfunctionFeb 27, 2024Leak/Splash; Output Problem; Leak/Splash; Output Problem

  IT WAS REPORTED THAT EKOS THERAPY WAS DISCONTINUED AS A RESULT OF A LEAK, AND THE PATIENT DID NOT RECEIVE AN ADEQUATE AMOUNT OF LYTIC. AN EKOSONIC ENDOVASCULAR DEVICE, 135X50CM WAS SELECTED FOR USE. DURING EKOS THERAPY, AN OVERHEATING ALARM SOUNDED, AND UPON MOVING THE PATIENT, IT WAS NOTED THAT THE HUB OF THE EKOS DEVICE WAS LEAKING. IT WAS UNCONFIRMED WHETHER THE LEAK WAS ATTRIBUTED TO COOLANT OR LYTIC, BUT THE PHYSICIAN BELIEVED THE LEAK TO BE LYTIC. ULTRASOUND THERAPY WAS DISCONTINUED, AND THE EKOS DEVICE WAS CONTINUED TO BE USED AS A STANDARD INFUSION CATHETER, DESPITE THE LEAK. THROMBUS RESOLUTION WAS NOT ACHIEVED, AND THE PHYSICIAN REPORTED THAT THE PATIENT DID NOT RECEIVE AN ADEQUATE AMOUNT OF LYTIC. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18789780 ↗
• InjuryDec 6, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT CATHETER EXCHANGE WAS REQUIRED. A 135X50CM EKOSONIC ENDOVASCULAR CATHETER WAS SELECTED FOR USE IN AN EKOS PROCEDURE. THE EKOSONIC ENDOVASCULAR CATHETER WAS PLACED; HOWEVER THE CATHETER WAS PULLED FROM THE PATIENT THE NEXT DAY DUE TO A LEAK. THE CATHETER WAS REPLACED WITH ANOTHER CATHETER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18277780 ↗
• MalfunctionNov 6, 2023Break; Electrical /Electronic Property Problem; Defective Device; Break; Electrical /Electronic Property Problem; Defective Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17OCT2023. AN EKOSONIC ENDOVASCULAR DEVICE, 135X50CM WAS SELECTED FOR USE IN A UNILATERAL EKOS PROCEDURE. AFTER APPROXIMATELY 10 HOURS OF EKOS THERAPY, THE CONTROL UNIT BEGAN DISPLAYING MULTIPLE ERROR MESSAGES. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ISSUE. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED, BUT THE PATIENT STATUS WAS REPORTED AS STABLE, BUT RUNNING A FEVER. HOWEVER, DEVICE ANALYSIS REVEALED THE ULTRASONIC CORE (USC) WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18075048 ↗
• InjuryMay 24, 2023Leak/Splash; Obstruction of Flow; Leak/Splash; Obstruction of Flow

  IT WAS REPORTED THAT THERE WAS A DRUG LEAK AND OCCLUSION. A 135X50CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR USE IN A LOWER EXTREMITY PROCEDURE. THE CATHETER WAS PLACED, AND INFUSION BEGAN. AFTER 9.5 HOURS OF THERAPY, IT WAS REPORTED THAT THE DRUG PORT WAS LEAKING AT THE HUB, AND BLOOD WAS COMING BACK UP THE TUBING CAUSING AN OCCLUSION. ATTEMPTS WERE MADE TO FLUSH AND CHANGE THE STOPCOCK, BUT THE LEAK WAS STILL OCCURRING. IT WAS DECIDED TO DISCONTINUE THE DRIP AND BRING THE PATIENT BACK TO REEVALUATE AND ATTEMPT TO FIX THE THROMBUS BURDEN IN THE VESSEL. THE PATIENT WAS BROUGHT BACK TO THE CATH LAB, AND FLOW WAS RESTORED USING ALTERNATIVE MEASURES THAT INCLUDED ANGIOJET AND BALLOON ANGIOPLASTY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16997142 ↗
• MalfunctionApr 25, 2023Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 31 MAR 2023. AN EKOS ENDOVASCULAR DEVICE, 135X50CM WAS SELECTED FOR USE IN THE ANGIOPLASTY PROCEDURE TO TREAT THE PATIENT'S DEEP VEIN THROMBOSIS. THE CATHETER WAS PLACED IN THE CATHETERIZATION LAB, AND THE PATIENT WAS TRANSFERRED TO THE ICU TO COMPLETE TREATMENT. SHORTLY AFTER THE PATIENT ARRIVED IN THE ICU, IT WAS NOTED THAT THE PATIENT'S BEDDING WAS WET. THE PHYSICIAN WAS NOTIFIED. IT WAS OBSERVED THAT CLEAR FLUID WAS DRIPPING FROM SOMEWHERE AROUND THE WHITE PORTION OF THE CATHETER. IT WAS UNDETERMINED WHETHER THE FLUID WAS LYTIC OR COOLANT. THE PHYSICIAN EXCHANGED THE EKOS ENDOVASCULAR DEVICE WHILE THE PATIENT WAS STILL IN THE ICU. THE ISSUE WAS RESOLVED, AND THE PATIENT RECEIVED THE INTENDED AMOUNT OF LYTIC FROM THE SECOND DEVICE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. HOWEVER, DEVICE ANALYSIS REVEALED THE DEVICE WAS LEAKING FROM THE DRUG LUMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811864 ↗
• InjuryMar 9, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT HAD TO RETURN TO THE CATHETERIZATION LAB FOR DEVICE REPLACEMENT. AN EKOS ENDOVASCULAR DEVICE, 135X50CM WAS SELECTED FOR USE. THE DEVICE WAS INSTALLED IN THE PATIENT WITH NO COMPLICATIONS OR DEFECTS NOTED. THE PATIENT WAS SENT TO THE ICU. AFTER APPROXIMATELY 45 MINUTES OF TREATMENT IN THE ICU, IT WAS NOTED THAT THE CATHETER WAS LEAKING AT THE HUB AND THE PHYSICIAN WAS NOTIFIED. IT WAS UNDETERMINED WHETHER THE LEAK WAS FROM THE DRUG LINE OR THE COOLANT LINE. THE PATIENT WAS BROUGHT BACK TO THE CATHETERIZATION LAB AND THE EKOS ENDOVASCULAR DEVICE WAS REMOVED AND REPLACED WITH A NEW ONE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED TO THE PATIENT. THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518372 ↗
• MalfunctionJan 26, 2023Break; Break

  IT WAS REPORTED THAT THE ULTRASONIC CORE BROKE. AN EKOSONIC ENDOVASCULAR DEVICE, 135X50CM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE CATHETER WAS IN PLACE INSIDE THE PATIENT'S LEG, AND THE ULTRASONIC CORE WAS LOADED. SOMETHING FELT LOOSE, SO THE ULTRASONIC CORE WAS PULLED OUT, AND IT WAS DISCOVERED TO BE BROKEN IN HALF. THE CATHETER HAD TO BE REMOVED TO PULL THE REMAINING PORTION OF THE ULTRASONIC CORE. A NEW EKOSONIC ENDOVASCULAR DEVICE, 135X30CM WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16251438 ↗
• InjuryJul 5, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ALERT. IF THE PATIENT IS BROUGHT BACK TO THE CATHETERIZATION LAB FOR CATHETER REPLACEMENT, THIS IS CONSIDERED AN ADDITIONAL INTERVENTION. A 135X50CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR A LEFT LOWER EXTREMITY DEEP VEIN THROMBOSIS (DVT) PROCEDURE. THERAPY RUN TIME WAS 19 MINUTES AND 30 SECONDS. DURING THE PROCEDURE, A RED ALARM E311 WAS DISPLAYED ON THE SCREEN. ALL CONNECTIONS WERE VERIFIED TO BE SECURE. NO BENT PINS OR FLUID INGRESS WAS OBSERVED. THE CONNECTOR INTERFACE CABLE (CIC) WAS SWITCHED TO A DIFFERENT CHANNEL AND SWITCHED TO A NEW CIC; HOWEVER, THERE WAS NO RESOLUTION. THE CAPITAL EQUIPMENT WAS SWITCHED TO A NEW ONE BUT THE SAME ALARM OCCURRED. THE PATIENT WAS IN PAIN, AND WAS BROUGHT BACK TO THE CATHETERIZATION LAB FOR DEVICE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 14915152 ↗
• InjuryMar 12, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THROMBUS OCCURRED. AN EKOSONIC CATHETER WAS SELECTED FOR USE TO TREAT A THROMBUS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE THROMBUS WAS NOTED TO BE ACUTE AND CHRONIC. HEPARIN WAS GIVEN AT 12MG/HR AND LYTIC AT 1 MG/HR OVER THE COURSE OF 24 HOURS. DURING TREATMENT OF THE THROMBUS WITH THE EKOSONIC CATHETER, THE CLOT WAS NOT CLEARED UP, AND IT INCREASED IN SEVERITY WHILE THE CATHETER WAS IN PLACE. THE PHYSICIAN OBSERVED THAT THE PULSE WAS LOST IN THE FOOT. THE INCREASE IN THROMBUS WAS ATTRIBUTED TO A CATHETER MALFUNCTION BY THE PHYSICIAN. THE PROCEDURE WAS THEN COMPLETED THE FOLLOWING DAY WITH A CDT CATHETER. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13744542 ↗
• InjuryMar 11, 2022Break; Defective Device; Break; Defective Device

  IT WAS REPORTED THE ULTRASONIC CORE (US WIRE) FRACTURED. A 135CM 50CM EKOSONIC KIT WAS USED DURING A BILATERAL DEEP VEIN THROMBOSIS (DVT) THERAPY PROCEDURE. TEN HOURS INTO TREATMENT, AN ALARM OCCURRED, AND WAS UNABLE TO BE RESOLVED THROUGH TROUBLESHOOTING SO ULTRASOUND WAS DISCONTINUED AND TREATMENT WAS CONTINUED BY USING THE EKOS CATHETER AS AN INFUSION CATHETER. LATER ON, THE PATIENT WAS SENT FOR RECHECK AND IT WAS DISCOVERED THAT THE US WIRE BROKE AND HAD MIGRATED INTO THE PATIENT'S VASCULATURE. THE FRACTURED PORTION WAS ABLE TO BE SUCCESSFULLY SNARED OUT OF THE PATIENTS LEFT ILIAC VEIN AND ALL EKOS COMPONENTS WERE REMOVED. BLOOD FLOW WAS RESTORED TO THE PATIENTS LEFT LEG DESPITE THE PROBLEM WITH THE US WIRE. THE PHYSICIAN WAS ABLE TO USE A MANUAL SUCTION DEVICE TO REMOVE THE RESIDUAL CLOT RESIDUE LEFT OVER AND THEN PERFORMED ANGIOPLASTY AND FINALLY PLACED A WALLSTENT. NO FURTHER PATIENT COMPLICATIONS OCCURRED AND THE PHYSICIAN WAS HAPPY WITH THE OVERALL RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13733224 ↗
• InjuryMar 10, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THROMBUS OCCURRED. AN EKOSONIC CATHETER WAS SELECTED FOR USE TO TREAT A THROMBUS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE UNDERLYING MEDICAL CONDITION OF THE PATIENT WAS SUBACUTE ON THROMBUS. HEPARIN WAS GIVEN AT 12MG/HR AND LYTIC AT 1 MG/HR OVER THE COURSE OF 24 HOURS. DURING TREATMENT OF THE THROMBUS WITH THE EKOSONIC CATHETER, THE CLOT WAS NOT CLEARED UP, AND IT INCREASED IN SEVERITY WHILE THE CATHETER WAS IN PLACE. THE PHYSICIAN OBSERVED THAT THE PULSE WAS LOST IN THE FOOT. THE INCREASE IN THROMBUS WAS ATTRIBUTED TO A CATHETER MALFUNCTION BY THE PHYSICIAN. THE PROCEDURE WAS THEN COMPLETED THE FOLLOWING DAY WITH A CDT CATHETER. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13726893 ↗
• MalfunctionFeb 24, 2022Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT THE ULTRASONIC CORE BROKE. AN EKOSONIC KIT 135CM 50CM TZ WAS SELECTED FOR USE TO TREAT DEEP VEIN THROMBOSIS (DVT). THE EKOS INFUSION CATHETER WAS ADVANCED INTO PLACE WITHOUT ANY ISSUES. THE ULTRASONIC INNER CORE WAS ADVANCED INTO THE INFUSION CATHETER, HOWEVER, IT WOULD ONLY ADVANCE APPROXIMATELY TWO THIRDS OF THE WAY INTO THE CATHETER. IT WAS REMOVED AND FLUSHED. A STANDARD .035 GUIDEWIRE WAS ADVANCED TO CHECK FOR ANY OBSTRUCTIONS; NONE WERE FOUND. FLUOROSCOPY SHOWED NO SIGNS OF ANY KINKS IN THE CATHETER. THE ULTRASONIC INNER CORE WAS ADVANCED AGAIN, AND BECAME STUCK. WHEN IT WAS ATTEMPTED TO BE REMOVED, IT BROKE INSIDE THE CATHETER. THE ENTIRE CATHETER INCLUDING THE BROKEN COMPONENT WERE SUCCESSFULLY REMOVED. ANOTHER CATHETER WAS SELECTED FOR USE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13592624 ↗
• MalfunctionSep 24, 2021Difficult to Remove; Difficult to Advance; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Difficult to Advance; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. AN EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR USE DURING A DEEP VEIN SUBCLAVIAN THROMBOLYSIS. THE INFUSION CATHETER WAS ENTERED THROUGH THE FEMORAL VEIN WITHOUT ISSUE. WHEN THE ULTRASONIC CORE WAS ADVANCED IT WAS DIFFICULT TO ADVANCE THROUGH THE SHEATH. AT THIS TIME, THE DEVICE WAS THEN REMOVED AND DIFFICULTLY REMOVING THE CATHETER WAS ALSO NOTED. UPON EXAMINATION POST REMOVAL, THE TIP WAS NOTED TO BE KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER EKOSONIC CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12528966 ↗
• InjuryApr 19, 2021Break; Defective Device; Break; Defective Device

  IT WAS REPORTED THAT AN ULTRASONIC CORE FRACTURE OCCURRED. AN EKOSONIC CATHETER WAS SELECTED FOR USE DURING A DEEP VEIN THROMBOSIS PROCEDURE. DURING THE PROCEDURE AN ALL MSD GROUPS DISABLED ALARM OCCURRED. THE ALARM WAS UNABLE TO BE RESOLVED; THEREFORE, THE PROCEDURE WAS COMPLETED BY RUNNING THE CATHETER AS A STANDARD INFUSION CATHETER. UPON RECHECK THE FOLLOWING DAY, IT WAS DISCOVERED THAT THE ULTRASONIC CORE WIRE HAD BROKE INSIDE THE PATIENT. THE CATHETER WAS SUCCESSFULLY SNARED OUT WITH A NON-BSD SNARE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686352 ↗