MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC KIT 106CM 12CM TZ; CATHETER, CONTINUOUS FLUSH

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 07/21/2021

Event Type  malfunction  

Event Description

It was reported a coolant 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.

Event Description

It was reported a coolant 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 coolant infusion pump alerts and obstruction within device.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 no alarms presented.Blood was visible in the coolant and drug luer but neither caused resistance when flushing during analysis.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.Secondary findings of a crack in the usc luer on the manifold were most probably caused by overtightening the usc luer.Inspection of the remainder of the device revealed no damage or irregularities.

• 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 Key: 12318760
• MDR Text Key: 266408947
• Report Number: 2134265-2021-10233
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• PMA/PMN Number: K182324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500-55112
• Device Catalogue Number: 500-55112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Date Manufacturer Received: 09/08/2021
• Patient Sequence Number: 1