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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC KIT 106CM 30CM TZ; CATHETER, CONTINUOUS FLUSH
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EKOS CORPORATION EKOSONIC KIT 106CM 30CM TZ; CATHETER, CONTINUOUS FLUSH Back to Search Results
Model Number 500-55130
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Event Date 11/16/2020
Event Type  Injury  
Event Description
It was reported that two marker bands embolized in the patient.An ekosonic catheter was selected for use during a deep vein thrombosis procedure.The catheter was placed in the right iliac vein via the left popliteal vein.The left iliac was occluded.Patient had a previous right iliac stent.During placement of the catheter, a small amount of resistance was noted in the beginning of catheter placement.After the distal portion of the catheter was through the stent, they visualized placement under fluoroscopy.The distal portion of the catheter was noted to have gone through the outside of the stent and caught on the strut.The distal marker band migrated to the right atrium of the heart.The proximal marker had not passed through the stent but came off the catheter.The physician was able to snare the proximal marker band to the left side and place a stent to secure the marker band against the vessel wall of the left iliac vein.The distal marker band remains in the right atrium, imbedded in the papillary muscle.The physician attempted to retrieve the marker band from the heart, but was unsuccessful.The patient will return in a week for follow up chest imaging.No patient consequences were reported.
 
Manufacturer Narrative
H6: additional code added device evaluation: the infusion catheter came back for analysis without the ultrasonic core and the cables cut off.The device serial number could not be verified because the cable was cut off.Measurements of the tubing indicated the device was 106x30 cm in length.Both marker bands were confirmed to be missing with witness marks on the tubing.The witness marks confirmed the initial swaging of the radio-opaque bands.Damage was seen on the tubing in the treatment zone region, likely from the marker bands shearing along the tubing.Further tool marks were seen at 78.2 cm distal to the strain relief.A kink was seen at 55.1 cm distal to the strain relief and the tubing was noted to be stretched with wavy stiffening wires throughout the device.The device failed ring gage testing over the regions of damage in the treatment zone however it was noted the gage was able to pass over each witness marks itself.There was no evidence of manufacturing issues because the ro markers were confirmed to be swaged in the correct position.Additional information determined the sheath used is not recommended in the instructions for use.
 
Event Description
It was reported that two marker bands embolized in the patient.An ekosonic catheter was selected for use during a deep vein thrombosis procedure.The catheter was placed in the right iliac vein via the left popliteal vein.The left iliac was occluded.Patient had a previous right iliac stent.During placement of the catheter, a small amount of resistance was noted in the beginning of catheter placement.After the distal portion of the catheter was through the stent, they visualized placement under fluoroscopy.The distal portion of the catheter was noted to have gone through the outside of the stent and caught on the strut.The distal marker band migrated to the right atrium of the heart.The proximal marker had not passed through the stent but came off the catheter.The physician was able to snare the proximal marker band to the left side and place a stent to secure the marker band against the vessel wall of the left iliac vein.The distal marker band remains in the right atrium, imbedded in the papillary muscle.The physician attempted to retrieve the marker band from the heart, but was unsuccessful.The patient will return in a week for follow up chest imaging.No patient consequences were reported.
 
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Brand Name
EKOSONIC KIT 106CM 30CM TZ
Type of Device
CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
EKOS CORPORATION
11911 north creek parkway s.
bothell WA 98011
MDR Report Key11007911
MDR Text Key221487950
Report Number2134265-2020-17306
Device Sequence Number1
Product Code KRA
Combination Product (y/n)N
PMA/PMN Number
K183361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number500-55130
Device Catalogue Number500-55130
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2020
Date Manufacturer Received12/29/2020
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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