MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 135X12CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-56112
Medical Device Problem Codes	Device Alarm System (1012); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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.
Additional 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 or Problem 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.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 135X12CM
• Common Device Name: 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 Key: 12318748
• Report Number: 2134265-2021-10232
• Device Sequence Number: 17049121
• Product Code: KRA
• UDI-Device Identifier: 00858593006264
• UDI-Public: 00858593006264
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K182324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/26/2023
• Device Model Number: 500-56112
• Device Catalogue Number: 500-56112
• Device Lot Number: 0010489021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 09/10/2021; 03/08/2022
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 09/29/2021; 03/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown