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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 135X12CM; CATHETER, CONTINUOUS FLUSH
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BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 135X12CM; CATHETER, CONTINUOUS FLUSH Back to Search Results
Model Number 500-56112
Device Problems Device Alarm System (1012); Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2021
Event Type  malfunction  
Event Description
It was reported a drug occlusion occurred and required an additional procedure.Two ekosonic kit 106cm 12cm tz catheters were placed in the groin through an unspecified 6f sheath for the treatment of a bilateral pulmonary embolism case.After seven hours of therapy, the coolant pump was alarming on one of the catheters.Troubleshooting was attempted but was unsuccessful.While trying to fix the coolant occlusion issue, the catheter placed in the other pulmonary artery started alarming on the drug port.Again troubleshooting was attempted but was unsuccessful.The catheters were removed and the patient still had residual clotting so a second ekos therapy procedure had to be performed the following day.
 
Manufacturer Narrative
Device evaluated by mfr: the ekos catheter was returned to boston scientific for analysis.The device was inspected for any damage or irregularities.The complaint was for drug infusion pump alerts and obstruction within device.There was blood noted in the drug luer.The device showed 13 of the 15 drug holes occluded with 2 holes clear.The device was run in a water bath for 15 minutes during which most of the drug holes opened and no alarms presented.Blood was visible in the drug luer but did not cause resistance when flushing during analysis.Foreign matter was seen embedded in the infusion catheter 10.5 cm from the distal end but was not blocking any drug holes.The ultrasonic core was able to traverse the length of the infusion catheter during analysis.Inspection of the remainder of the device revealed no damage or irregularities.Device analysis determined the condition of the returned device was not consistent with the reported information.The reported complaint of difficult to flush and obstruction within device were not confirmed.
 
Event Description
It was reported a drug occlusion occurred and required an additional procedure.Two ekosonic kit 106cm 12cm tz catheters were placed in the groin through an unspecified 6f sheath for the treatment of a bilateral pulmonary embolism case.After seven hours of therapy, the coolant pump was alarming on one of the catheters.Troubleshooting was attempted but was unsuccessful.While trying to fix the coolant occlusion issue, the catheter in the other pulmonary artery started alarming on the drug port.Again troubleshooting was attempted but was unsuccessful.The catheters were removed and the patient still had residual clot so a second ekos therapy procedure had to be performed the following day.
 
Manufacturer Narrative
Device evaluated by mfr: the ekos catheter was returned to boston scientific for analysis.The device was inspected for any damage or irregularities.The complaint was for drug infusion pump alerts and obstruction within device.There was blood noted in the drug luer.The device showed 13 of the 15 drug holes occluded with 2 holes clear.The device was run in a water bath for 15 minutes during which most of the drug holes opened and no alarms presented.Blood was visible in the drug luer but did not cause resistance when flushing during analysis.Foreign matter was seen embedded in the infusion catheter 10.5 cm from the distal end but was not blocking any drug holes.The ultrasonic core was able to traverse the length of the infusion catheter during analysis.Inspection of the remainder of the device revealed no damage or irregularities.Device analysis determined the condition of the returned device was not consistent with the reported information.The reported complaint of difficult to flush and obstruction within device were not confirmed.
 
Event Description
It was reported a drug occlusion occurred and required an additional procedure.Two ekosonic kit 106cm 12cm tz catheters were placed in the groin through an unspecified 6f sheath for the treatment of a bilateral pulmonary embolism case.After seven hours of therapy, the coolant pump was alarming on one of the catheters.Troubleshooting was attempted but was unsuccessful.While trying to fix the coolant occlusion issue, the catheter in the other pulmonary artery started alarming on the drug port.Again troubleshooting was attempted but was unsuccessful.The catheters were removed and the patient still had residual clot so a second ekos therapy procedure had to be performed the following day.
 
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Brand Name
EKOSONIC ENDOVASCULAR DEVICE, 135X12CM
Type of Device
CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BTG EKOS
11911 n. creek parkway s.
bothell WA 98011
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12318748
MDR Text Key266408765
Report Number2134265-2021-10232
Device Sequence Number1
Product Code KRA
UDI-Device Identifier00858593006264
UDI-Public00858593006264
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,Followup
Report Date 03/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/26/2023
Device Model Number500-56112
Device Catalogue Number500-56112
Device Lot Number0010489021
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/26/2020
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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