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 Bradycardia (1751); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 03/08/2017

Event Type  Injury  

Manufacturer Narrative

The subject experienced pulseless electrical activity during the apt procedure on (b)(6) 2017.Patient became bradycardic and hypotensive.Acls was initiated and the patient was placed on extracorporeal membrane oxygenation ecmo.The patient recovered from pea.There were no device malfunctions reported.The principle investigator classified the relationship of the event of pea as definitely related to the procedure.Relationship to ekos for all events is marked unknown.No additional information will be available.

Event Description

On 11 july 2019, a clinical study sae was reported.Subject (b)(6) is a retrospective patient enrolled in (b)(6).This patient is a (b)(6)-year-old female.The patient had ekos therapy initiated at 16:43 on (b)(6) 2017.She went into pulseless electrical activity (pea) and hypotension at 17:23.Acls was initiated and the patient was placed on ecmo.The event of pea is recorded as resolved by 17:40.On (b)(6) 2017, the patient had some blood in the et tube, graded as mild.It was noted that the blood in et tube occurred after apt treatment was completed and possibly due to from shock to the liver.The patient was extubated on (b)(6) 2017.On (b)(6) 2017, the patient experienced dyspnea and desaturated to 89% on 15l o2.The patient was placed on cpap with immediate relief.The patient was titrated off cpap and was on 14l o2.On (b)(6) 2017, the patient was reintubated.On (b)(6) 2017, the patient's ejection fraction was 35% when it was previously normal.An ivc filter was placed due to heart strain and lle clot burden.The principle investigator classified the relationship of the pea event as definitely related to the procedure.The principle investigator's assessment of the relationship to ekos for all events is marked as unknown.

• 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: 8874650
• MDR Text Key: 153999882
• Report Number: 3001627457-2019-00022
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140151
• 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: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• 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: 07/11/2019
• 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: 71 YR