MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC KIT 135CM 50CM TZ; CATHETER, CONTINUOUS FLUSH

Model Number 500-56150

Device Problems Break (1069); Difficult to Advance (2920); Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2021

Event Type  malfunction  

Event Description

It was reported that a catheter break occurred.The patient's angiograms revealed a thrombosed bypass graft.An ekosonic kit 135cm 50cm was selected for treatment.The patients vascular iliac anatomy had an acute angle; the physician used a 0.035 non-bsc guidewire wire for support to guide the eksonic catheter to position.When placing the catheter, contralateral access was difficult, requiring a slow steady push of 1mm at a time on the ultrasonic core with backward tension on the outer infusion catheter.The ultrasonic core was removed twice prior to making the turn over the iliac bifurcation to ensure the infusion catheter was flushed.After connecting the infusions, the ekos therapy was started with almost an immediate alarm.The alarm indicated thermocouple exhaustion.Troubleshooting was performed and coolant rates were increased in increment, with permission from the attending physician.They were able to get the catheter to perform with a coolant rate of 85ml/hr.The ekos therapy ran for 30 minutes when the white c with red thermometer alarmed again.The coolant was again increased by increments of 10 ml/hr.As they continued to discuss the patient care plan the alarm icon persisted, beyond each 10ml increase.Rep called the physician to let him know the ekos catheter would run as an infusion catheter, decreasing the coolant to a rate of 20ml.He gave his approval and understood.The following day the physician removed the ultrasonic core from the infusion catheter and placed a cap at the end to prevent bleed back.He then utilized a 10cc syringe of heparinized saline and contrast to perform a hand injection from the side port of the sheath to visualize the progress of ekos catheter placement.The hep/saline, dye solution was injected around the ekos catheter and demonstrated an open bypass graft and a segment of the ultrasonic core remaining inside the infusion catheter, which was confirmed by radiography.Angiograms confirmed the patient had flow all the way down the leg past the ankle.The physician stated the treatment was a success, removed the sheath, used a closure device to close the artery.The patient is stable, doing well, and will be discharged home today.

Manufacturer Narrative

H3 - device evaluated by manufacturer: the ekos catheter was returned to boston scientific for analysis.The device was inspected for any damage or irregularities.A break was confirmed in the ultrasonic core (usc) catheter 90.7cm from the luer barb.The remaining section of the usc catheter was still in place in the infusion catheter at the time the device was returned for analysis.The remaining section of usc catheter was measured at 50.7 cm.Multiple pinch marks were noted on the usc catheter.Device analysis determined the condition of the returned device was consistent with the reported information.Due to the device damage functional testing could not be completed.The procedure event log shows the device was connected for therapy.The log shows that there were issues providing power to groups 2-5 of the device.Thermal coupler # 6 showed intermittent, likely faulty readings which caused the white c red thermometer alarm.The device was reading a phase above the maximum value, suggesting damage to the catheter.A total of 1 minute of ultrasound therapy was delivered on the device.There appeared to be no issue with the control unit.

Event Description

It was reported that a catheter break occurred.The patient's angiograms revealed a thrombosed bypass graft.An ekosonic kit 135cm 50cm was selected for treatment.The patients vascular iliac anatomy had an acute angle; the physician used a 0.035 non-bsc guidewire wire for support to guide the eksonic catheter to position.When placing the catheter, contralateral access was difficult, requiring a slow steady push of 1mm at a time on the ultrasonic core with backward tension on the outer infusion catheter.The ultrasonic core was removed twice prior to making the turn over the iliac bifurcation to ensure the infusion catheter was flushed.After connecting the infusions, the ekos therapy was started with almost an immediate alarm.The alarm indicated thermocouple exhaustion.Troubleshooting was performed and coolant rates were increased in increment, with permission from the attending physician.They were able to get the catheter to perform with a coolant rate of 85ml/hr.The ekos therapy ran for 30 minutes when the white c with red thermometer alarmed again.The coolant was again increased by increments of 10 ml/hr.As they continued to discuss the patient care plan the alarm icon persisted, beyond each 10ml increase.Rep called the physician to let him know the ekos catheter would run as an infusion catheter, decreasing the coolant to a rate of 20ml.He gave his approval and understood.The following day the physician removed the ultrasonic core from the infusion catheter and placed a cap at the end to prevent bleed back.He then utilized a 10cc syringe of heparinized saline and contrast to perform a hand injection from the side port of the sheath to visualize the progress of ekos catheter placement.The hep/saline, dye solution was injected around the ekos catheter and demonstrated an open bypass graft and a segment of the ultrasonic core remaining inside the infusion catheter, which was confirmed by radiography.Angiograms confirmed the patient had flow all the way down the leg past the ankle.The physician stated the treatment was a success, removed the sheath, used a closure device to close the artery.The patient is stable, doing well, and will be discharged home today.

• Brand Name: EKOSONIC KIT 135CM 50CM TZ
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s.; bothell WA 98011
• MDR Report Key: 11423696
• MDR Text Key: 240031056
• Report Number: 2134265-2021-02835
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006318
• UDI-Public: 00858593006318
• Combination Product (y/n): N
• PMA/PMN Number: K183361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2023
• Device Model Number: 500-56150
• Device Catalogue Number: 500-56150
• Device Lot Number: 0011223182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 03/26/2021
• Supplement Dates FDA Received: 03/31/2021
• Patient Sequence Number: 1