MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER; CATHETER, CONTINUOUS FLUSH

Catalog Number 500-55112

Device Problems Complete Blockage (1094); Occlusion Within Device (1423); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2015

Event Type  malfunction  

Manufacturer Narrative

The infusion pump was not manufactured by ekos.There are possible reasons for the iv pump alarm.These include: the pressure setting (pump psi) is set too low, aspiration of blood into the drug line, kinking the line due to patient positioning or patient movement, or suturing down the line such that it becomes occluded.A nurse at the site told an ekos sales representative that the drug catheter had been tied down with a suture by a hospital technician.The device was not returned for evaluation, so ekos cannot determine the cause of the pump alarm.The ekosonic mach4 endovascular device instructions for use, clearly state to prepare the catheters outside of the body by flushing them prior to placement in the patient.In addition, the instructions: warn against drawing blood back into the drug lumens, as blood may occlude the drug holes.Despite good faith attempts, ekos was unable to obtain additional information.Device was not returned for evaluation.

Event Description

The customer called the ekos helpline because the drug port on one of the iv pumps in a bilateral pe case was alarming.The customer denied aspirating into the line.Prior to the call the customer unsuccessfully tried to flush the drug port with a 3 cc syringe.While on the call the customer tried flushing again and she said there was a lot of resistance but she was able to flush it a few more times with a 3cc syringe.The pump stopped alarming before the call ended.The patient was stable at the time of the call and was receiving ekos therapy on one side.Ekos sales representatives followed-up with the site on two subsequent occasions to see if there were further problems and to check on the patient.The last report was that the patient was doing "fine." the ekos therapy continued on one side with no problems, and that was the side with the most clot.The other side that had the problem with the pump received a 2.5 mg bolus of thrombolytic.The infusion pump was not manufactured by ekos.The catheters were not saved by the customer so they could not be evaluated.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• Manufacturer (Section G): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• Manufacturer Contact: susan wray ; 11911 north creek parkway s; bothell, WA 98011-8809 ; 4254891267
• MDR Report Key: 5355863
• MDR Text Key: 35493607
• Report Number: 3001627457-2016-00001
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 500-55112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1