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

Model Number 500-56150

Device Problem Device Alarm System (1012)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 09/04/2020

Event Type  Injury  

Event Description

It was reported that a downstream occlusion alarm occurred to the coolant line on the infusion pump.An ekosonic catheter was selected for use during a peripheral arterial occlusion (pao) procedure.After the catheter was placed, the tissue plasminogen activator (tpa) and ultrasound were started in the intensive care unit (icu).Upon starting treatment, a downstream occlusion alarm occurred to the coolant line on the infusion pump.At this time, they attempted to flush the line with 3 cc syringe 1 cc syringe, reducing flow rate to 20 cc/hour, then reducing to 15 cc/hour, and increasing flow rate above 35 cc/hour, but was unsuccessful.Ultrasound was never started.The physician decided to bring the patient back and place a competitors infusion catheter to complete the procedure.Lysis was completed and no further complications were reported.

Manufacturer Narrative

The catheter came back for analysis.The device was run for 15 minutes in-house without alarm.Microscopic inspection showed a kink at 99.2 cm distal to the strain relief on the infusion catheter (ic).Further, tool marks were seen at 86.7 cm, 70.3cm, and 2.1 cm distal to the strain relief.The stiffening wire was noted to be wavy.There was a bend in the core wire in the treatment zone as well as a minor tool mark at 13.8 cm on the ultrasonic core (usc).The usc did still pass ring gage testing.The returned catheter was reported initially for a coolant occlusion.Investigation was able to confirm the reported coolant occlusion failure through device analysis because of the lack of vent holes which were corrected through design.While the pump alarm was not recreated in house, the lack of coolant vent holes and the kink damage to the catheter were likely contributing factors to the problem.The coolant occlusion was resolved at the time by troubleshooting.

Event Description

It was reported that a downstream occlusion alarm occurred to the coolant line on the infusion pump.An ekosonic catheter was selected for use during a peripheral arterial occlusion (pao) procedure.After the catheter was placed, the tissue plasminogen activator (tpa) an ultrasound were started in the intensive care unit (icu).Upon starting treatment, a downstream occlusion alarm occurred to the coolant line on the infusion pump.At this time, they attempted to flush the line with 3 cc syringe 1 cc syringe, reducing flow rate to 20 cc/hour, then reducing to 15 cc/hour, and increasing flow rate above 35 cc/hour, but was unsuccessful.Ultrasound was never started.The physician decided to bring the patient back and place a competitors infusion catheter to complete the procedure.Lysis was completed and no further complications were reported.

• 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: 10605649
• MDR Text Key: 209138936
• Report Number: 2134265-2020-13434
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006318
• UDI-Public: 00858593006318
• Combination Product (y/n): N
• PMA/PMN Number: K182324
• 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: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2022
• Device Model Number: 500-56150
• Device Catalogue Number: 500-56150
• Device Lot Number: 0191010093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Date Manufacturer Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention