MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC KIT 106CM 24CM TZ; CATHETER, CONTINUOUS FLUSH

Model Number 500-55124

Device Problems Device Alarm System (1012); Difficult to Flush (1251); Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/03/2021

Event Type  Injury  

Event Description

It was reported that a catheter occlusion requiring additional intervention occurred.An ekosonic catheter was selected for use during a deep vein thrombosis procedure.At an unknown time during the procedure, the drug line of the catheter occluded.Troubleshooting steps were performed, which included flushing the line unsuccessfully.The infusion pump was also exchanged for another without resolution of the occlusion.It was then decided to bring the patient back to the procedure table for catheter replacement.The second catheter performed without issue and treatment was successfully completed with no patient complications reported.

Event Description

It was reported that a catheter occlusion requiring additional intervention occurred.An ekosonic catheter was selected for use during a deep vein thrombosis procedure.At an unknown time during the procedure, the drug line of the catheter occluded.Troubleshooting steps were performed, which included flushing the line unsuccessfully.The infusion pump was also exchanged for another without resolution of the occlusion.It was then decided to bring the patient back to the procedure table for catheter replacement.The second catheter performed without issue and treatment was successfully completed with no patient complications reported.

Manufacturer Narrative

The ekos device was returned to boston scientific for analysis.The device was received neatly coiled with blood present in the coolant and drug lines.The device was inspected for any damage or irregularities.The infusion catheter (ic) is missing the coolant holes on the distal end.This is addressed by bsc and the device was manufactured prior to the corrective action implementation.The ic device showed damage in the form of kinks 62 cm and 120 cm from the strain relief.The ic failed the outer diameter ring gage test at 63 cm from the strain relief.The ultrasonic core (usc) had pinch marks 4 cm and 40 cm from the luer barb.The usc was unable to advance through the ic in a water bath test.The usc stopped 119 cm from the strain relief.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage.Device analysis determined the condition of the returned device was consistent with the reported information of difficult to flush.It was considered likely that the pinch marks were secondary findings attributable to procedural issues.D4: device information updated.

• Brand Name: EKOSONIC KIT 106CM 24CM TZ
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s.; bothell WA 98011
• MDR Report Key: 11576594
• MDR Text Key: 242480216
• Report Number: 2134265-2021-03879
• Device Sequence Number: 1
• Product Code: KRA
• 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: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2022
• Device Model Number: 500-55124
• Device Catalogue Number: 500-55124
• Device Lot Number: 0191021104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Date Manufacturer Received: 04/16/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other