MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X12CM; 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 07/04/2022

Event Type  Injury  

Manufacturer Narrative

Device eval by manufacturer: the usc and the ic were returned.The usc had a two pinches/kinks at 14.3cm and 58.4cm from the strain relief.These pinches likely happened during placement of the device as it was advanced into position with an advancing tool.Blood was seen in the ic drug lines.Some wavy wires were seen throughout the device.Four of the drug holes on the ic appeared occluded with blood.During water bath testing the ic was able to be flushed with air and the majority of the drug holes showed bubbles.An infusion pump was connected to the drug port to see if the blood occluded holes would cause a pump alarm.After 20 minutes of drug line infusion, no pump alarm occurred.

Event Description

It was reported that a down stream drug occlusion occurred requiring additional intervention.Two 106cm x12cm ekosonic endovascular catheters were selected for treatment of a pulmonary embolism.The patient was brought from the interventional radiology (ir) lab to the intensive care unit (icu) with the catheters placed but without tpa infusing.When the catheters clotted the patient was taken back to the ir lab.One of the catheters was replaced.The second catheter was repositioned and the patient was returned to the icu.Upon the patient's return to the icu, therapy was restarted and running when an alarm indicating a downstream occlusion on both drug lines was received.The catheter was checked for kinks, closed stopcocks and closed roller clamps; there were none.Infusion rate and pump pressure were within the recommended range.The catheters were checked for coils or sutures; there were none.The nurse attempted to flush the catheters but was unsuccessful.The catheter was pulled back 1mm and flushing was reattempted but the line was unable to be flushed due to clotting.The patient was worsening possibly due to delay in treatment caused by the clotting of the catheters.The patient was placed on extracorporeal membrane oxygenation (ecmo) due to right ventricular failure and was transferred to another health care facility where she is under supervision and doing well.

• Brand Name: EKOSONIC 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15135616
• MDR Text Key: 296948970
• Report Number: 2134265-2022-08163
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006134
• UDI-Public: 00858593006134
• 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
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500-55112
• Device Catalogue Number: 500-55112
• Device Lot Number: 8035058943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female