MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOS ENDOVASCULAR DEVICE, 106X12CM; CATHETER, CONTINUOUS FLUSH

Device Problems Leak/Splash (1354); Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2022

Event Type  malfunction  

Manufacturer Narrative

Lot number - reported as - 211231041-441.

Event Description

It was reported that a fluid leak occurred at the manifold.A 106x12cm ekos endovascular device was selected for a bilateral pulmonary embolism case.Seven hours into the procedure, a fluid began leaking from the manifold.There were no alarms on the control unit (cu) or down stream occlusion (dso) to the iv pumps.Both channels showed the running animations, indicating there were no issues detected.The treatment was continued with no further actions.When the catheter was removed there was an occlusion in the catheter.There were no patient complications reported and the therapy was considered successful by the physician.

Manufacturer Narrative

D4: lot number - reported as - 211231041-441.Device/media analysis by manufacturer: both pieces of the ekos catheter were returned to boston scientific for analysis.The usc was still inserted in the infusion catheter and during decon flushing liquid was seen leaking from the distal end of the strain relief.The usc was removed from the ic with high resistance during decontamination.During investigation multiple kinks and wavy lines (stretching) were noted on the ic.The strain relief was removed, and accordion damage (stretching) was seen under the strain relief.A rupture of the infusion catheter was found at the distal end of the manifold under the strain relief.The tear is vertical around the catheter.Occluded drug pores were confirmed on the ic.These most probably occurred when the forward fluid movement of the lytic was lessened due to the leak at the hub.

Event Description

It was reported that a fluid leak occurred at the manifold.A 106x12cm ekos endovascular device was selected for a bilateral pulmonary embolism case.Seven hours into the procedure, a fluid began leaking from the manifold.There were no alarms on the control unit (cu) or down stream occlusion (dso) to the iv pumps.Both channels showed the running animations, indicating there were no issues detected.The treatment was continued with no further actions.When the catheter was removed there was an occlusion in the catheter.There were no patient complications reported and the therapy was considered successful by the physician.

• Brand Name: EKOS ENDOVASCULAR DEVICE, 106X12CM
• 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 Key: 14566247
• MDR Text Key: 293142006
• Report Number: 2134265-2022-06002
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1