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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC KIT 106CM 12CM TZ; CATHETER, CONTINUOUS FLUSH
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BOSTON SCIENTIFIC CORPORATION EKOSONIC KIT 106CM 12CM TZ; CATHETER, CONTINUOUS FLUSH Back to Search Results
Model Number 500-55112
Device Problems Device Alarm System (1012); Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/17/2021
Event Type  malfunction  
Event Description
It was reported that a downstream drug occlusion occurred.Two ekosonic endovascular catheters were selected for use during a bilateral pulmonary embolism catheter directed thrombolysis procedure.A dual lumen sheath with a twist lock hemostasis valve was used with the ekos catheters.This type of sheath is advised against.Tiny clots were noted to be coming out of the wire lumen of the ekos catheter when it was introduced into the right lung.Approximately, 38 minutes into therapy, a downstream occlusion occurred to the right sided catheter.Troubleshooting included changing intravenous (iv) pump, multiple flushes of the iv line and pulling the catheter back 1 cm.None of these attempts were successful.At this time, the physician decided discontinue therapy on the right side and run normal saline through, while continuing therapy on the left side.Approximately,1 hour later, a drug infusion pump alert occurred to the left side catheter.Troubleshooting was unable to resolve this issue and the procedure was discontinued at this time.No patient complications were reported.
 
Event Description
It was reported that a downstream drug occlusion occurred.Two ekosonic endovascular catheters were selected for use during a bilateral pulmonary embolism catheter directed thrombolysis procedure.A dual lumen sheath with a twist lock hemostasis valve was used with the ekos catheters.This type of sheath is advised against.Tiny clots were noted to be coming out of the wire lumen of the ekos catheter when it was introduced into the right lung.Approximately, 38 minutes into therapy, a downstream occlusion occurred to the right sided catheter.Troubleshooting included changing intravenous (iv) pump, multiple flushes of the iv line and pulling the catheter back 1 cm.None of these attempts were successful.At this time, the physician decided discontinue therapy on the right side and run normal saline through, while continuing therapy on the left side.Approximately,1 hour later, a drug infusion pump alert occurred to the left side catheter.Troubleshooting was unable to resolve this issue and the procedure was discontinued at this time.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: there was blood noted in the drug and coolant luer.The device showed 10 of the 15 drug holes occluded with 5 holes clear.The device was run in a water bath for 15 minutes and the in-house alaris pump alarmed when hooked to the drug line running at 35 ml/hr.The drug luer showed extreme resistance when trying to flush with a syringe.Inspection of the remainder of the device revealed no damage or irregularities.Device analysis determined the condition of the returned device was consistent with the reported information.
 
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Brand Name
EKOSONIC KIT 106CM 12CM TZ
Type of Device
CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12300574
MDR Text Key265795976
Report Number2134265-2021-10178
Device Sequence Number1
Product Code KRA
UDI-Device Identifier00858593006134
UDI-Public00858593006134
Combination Product (y/n)N
PMA/PMN Number
K182324
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/06/2024
Device Model Number500-55112
Device Catalogue Number500-55112
Device Lot Number8035003417
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2021
Date Manufacturer Received08/24/2021
Patient Sequence Number1
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