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

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

Patient Problems Anemia (1706); Chest Pain (1776); Dyspnea (1816); Hemorrhage/Bleeding (1888); Hemothorax (1896)

Event Date 05/01/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: event date was not reported and was approximated to (b)(6) 2021.References: lal, a., jena, n., deepthi, t., kaur, j., apala, d., & patel, k.(2021, may 15).Rare complications from ekos in patients of massive pulmonary embolism.Cardiovascular team collaboration solving unique cases (pp.Volume 77, issue 18).Atlanta: jacc.

Event Description

Reported via journal article that patient experienced chest pain, dyspnea, blood loss anemia, bleeding in the pleura, hemomediastinum, hemothorax, hemopericardium, had bilateral chest tubes placed and pericardial window procedure.The patient was found unresponsive at his home.The patient had cardiac and respiratory arrest and cpr was performed for 30 seconds.Upon the emergency room arrival he was having sinus tachycardia.Heart rate was 150 and respirations were 25.The patient was hypoxic and placed on a non-rebreather.Ekg showed complete right bundle branch block but no ischemic changes.Troponin level was 0.90.The patient went for a ct angiogram which showed bilateral massive pulmonary emboli with right heart strain with "flattening of ivs and rv to lv ratio 1.9." the patient was treated with ekos pe catheters.A bolus of 2mg x 2 of tpa, followed by 1 mg/hr for 6 hours through each catheter was ordered.After ekos, patient started having chest pain, sob, and lethargy with blood loss anemia, and his hemoglobin dropped from 11 to 5.9.Chest x-ray showed a widened mediastinum.A chest ct showed hemomediastinum and hemothorax.An echocardiogram showed hemopericardium.Bilateral chest tubes were placed, which drained 2 litres.The pericardial window was done and drained serosanguinous fluid and the patient was kept in a cardiac unit for close monitoring.No further complications were reported.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera propark; coyol alajuela ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12914386
• MDR Text Key: 282200051
• Report Number: 2134265-2021-14735
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2021
• 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; Other; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male