MAUDE Adverse Event Report: EKOS CORPORATION; CATHETER, CONTINUOUS FLUSH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Hematoma (1884); Nausea (1970); Pain (1994); Vomiting (2144); Pseudoaneurysm (2605)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.Article received date is used.Iskander, p.(2021).A case of subcapsular renal hematoma status post celiac artery thrombectomy.International journal of surgery case reports, 81, 105798.Doi:10.1016/j.Ijscr.2021.105798.

Event Description

It was reported via journal article that patient complications occurred.A case report detailed the events of a patient who presented to the hospital with persistent left-sided abdominal pain.A computed tomography (ct) scan of the abdomen and pelvis revealed splenomegaly, a soft tissue filling defect in the lumen of the celiac artery and thrombus was noted to extend up the common hepatic artery and splenic artery.At this time, an ekosonic endovascular system (ekos) catheter was introduced through the left iliac artery and positioned in the proximal portion of the celiac trunk to assist in a catheter assisted thrombolysis.Alteplase infusion was also initiated at 1 mg/hr as well as a heparin infusion at 500 units/hr.The patient tolerated the procedure well and the catheter was removed at bedside the following day.Patient was discharged on aspirin and apixaban for anticoagulation.The next day, patient presented to the emergency department with significant pain associated with shortness of breath and nausea.A repeat ct showed redemonstrations of the celiac thrombus and splenomegaly.Additionally, the left kidney showed evidence of left subscapular hematoma.A left superficial femoral artery pseudoaneurysm was also noted.Anticoagulation was discontinued and patient was made npo (nothing by mouth).Three days later the hematoma had increased.Patient was monitored for three more days and managed conservatively with intravenous fluids and pain medication.Patient remained hemodynamically stable and was discharged.

• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s.; bothell WA 98011 8809
• Manufacturer (Section G): EKOS CORPORATION INC.; 11911 north creek pkwy south; bothell 98011
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11822382
• MDR Text Key: 251281206
• Report Number: 2134265-2021-06254
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR