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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
Device Problems Device Alarm System (1012); Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/26/2021
Event Type  Injury  
Event Description
It was reported that a drug occlusion occurred resulting in catheter replacement.An ekosonic endovascular device was selected for use during a bilateral pulmonary embolism thrombolysis procedure.After catheter placement, the patient was moved to the intensive care unit (icu).Shortly after arrival to the icu, the hospital supplied infusion pump alarmed with a downstream occlusion to the drug line on both infusion pumps.Stopcocks and roller clamps were reported to be open.No catheter kinks were noted.The user flushed the line with a 10c and a 3cc syringe for no resolution.The drug infusion pump was also replaced and the alarm continued.All troubleshooting steps were exhausted.The physician decided to bring the patient back to the catheterization lab for catheter replacement.No further issues were reported.No patient consequences occurred.
 
Event Description
It was reported that a drug occlusion occurred resulting in catheter replacement.An ekosonic endovascular device was selected for use during a bilateral pulmonary embolism thrombolysis procedure.After catheter placement, the patient was moved to the intensive care unit (icu).Shortly after arrival to the icu, the hospital supplied infusion pump alarmed with a downstream occlusion to the drug line on both infusion pumps.Stopcocks and roller clamps were reported to be open.No catheter kinks were noted.The user flushed the line with a 10c and a 3cc syringe for no resolution.The drug infusion pump was also replaced and the alarm continued.All troubleshooting steps were exhausted.The physician decided to bring the patient back to the catheterization lab for catheter replacement.No further issues were reported.No patient consequences occurred.
 
Manufacturer Narrative
Device evaluated by mfr: the ekos device was returned to boston scientific for analysis.The device was received tangled and tightly coiled with blood present in the coolant and drug lines.Syringes were attached to every lumen and still holding fluids.The catheter was drained and then decontamination began.The device was inspected for any damage or irregularities.Slightly wavy lines were noted the length of the infusion catheter.Kinks were found at the strain relief and 130.4 cm from the strain relief.Of 15 drug pores, 8 were occluded with blood matter leaving 7 drug pores open.During the air test only three drug pores produced bubbles.When run on the in-house infusion pump the pump alarmed with 5ml/hr at 45 seconds.The pump was reset at 20ml/hr and alarmed at 8 minutes.It was considered likely that the pinch marks were secondary findings attributable to procedural issues.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
2546 calle primera
alajuela
CS  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12660451
MDR Text Key277361239
Report Number2134265-2021-13130
Device Sequence Number1
Product Code KRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182324
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 12/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/26/2021
Initial Date FDA Received10/19/2021
Supplement Dates Manufacturer Received11/29/2021
Supplement Dates FDA Received12/21/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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