MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number UNKNOWN

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

Patient Problems Cardiac Arrest (1762); Dyspnea (1816); Hypoxia (1918); Respiratory Failure (2484)

Event Date 07/10/2019

Event Type  Injury  

Manufacturer Narrative

The site reported the subject had an acute respiratory failure.Per the principle investigator respiratory failure was probably related to the interventional procedure and not related to the ekos system, thrombolytic drug or anticoagulation, however the presence of early hypoxia and desaturation in the presence of a pulmonary emboli contributed to the event.No device malfunction was reported.No additional information will be available.

Event Description

On 19 july 2019, a clinical study sae was reported.Subject (b)(6) is a patient enrolled in (b)(6).This patient is a 72-year-old caucasian female.The patient had reported that she experienced shortness of breath three days ago which began suddenly.She denied any associated chest paint or fevers.In the emergency department.The patient was hypoxic and walad on bipap to improve and stabilize oxygen saturations.Ct chest per pe protocol was ordered but unable to be performed due to difficulty of patient lying flat with shortness of breath.She also had elevated d-dimer.The patient was started on heparin drip with stat echo and noted to have dilated right ventricle.On (b)(6) 2019, the patient was taken to the operating room for ekos catheter placement and tpa to treat a bilateral large saddle type embolus.The patient had persistent hypoxia and desaturation throughout the early portion of the case, but then stabilized with increased ventilatory support from anaesthesia.At the conclusion of the procedure, she became progressively hypoxic and acidotic.The patient went into intermittent cardiac arrest and required total of 28 minutes of chest compressions with several rounds of epi, bicarbonate, calcium, atropine.She also required defibrillation for ventricular tachycardia/ventricular fibrillation (vt/vf).Ultimately, return of spontaneous circulation (rosc) was achieved but her cardiac function was severely decompensated from acute cardiogenic shock.Va ecmo was promptly initiated.The patient was stable at the conclusion of the procedure.The site documented this event as an acute respiratory failure.The relationship to the procedure was assessed as probable and not related to ekos system, thrombolytic or anticoagulant drug.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Type of Device: EKOSONIC ENDOVASCULAR CATHETER
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• Manufacturer (Section G): EKOS CORPORATION; 11911 north creek parkway; bothell WA 98011 8809
• Manufacturer Contact: sandara bausback-aballo ; 300 conshohocken state rd,; 300 four falls corporate ctr.; west conshohocken, PA 19428-2998 ; 6103311537
• MDR Report Key: 8898259
• MDR Text Key: 155508729
• Report Number: 3001627457-2019-00023
• 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: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 72 YR