MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Pulmonary Embolism (1498)

Event Date 07/31/2019

Event Type  Injury  

Manufacturer Narrative

The site documented that the patient had a recurrent pe.The primary investigator (pi) assessed this event as not related to the interventional procedure, ekos system, or thrombolytic and probably related to anticoagulant drug.The medical monitor (mm) assessed the sae as probably related to interventional procedure and ekos system and not related to thrombolytic and anticoagulants drugs.There were no device malfunctions documented.The event was not reported to ekos at the time it occurred.While the medical monitor reassessed the sae of recurrent pe and determined that it was related to the ekos device and procedure, a review of source documents demonstrated that the patient had been discharged home after the initial pe on (b)(6) 2019.Doppler studies performed on (b)(6) 2019 revealed dvt in the right lower extremity.Btg believes the recurrent pe was related to the dvt and anticoagulation and not the ekos device, however this event is being reported based on the independent medical monitor's assessment.No additional information will be available.

Event Description

Subject (b)(6) is a patient enrolled in the (b)(6) study.This patient is a (b)(6) male.The patient was treated for a bilateral pe on (b)(6) 2019.It was reported the patient was diagnosed with dvt and recurrent pe on (b)(6) 2019 and was classified as a serious adverse event (sae).It is not known what intervention was performed to treat the recurrent pe.The source documents states that there were no complications during the procedure on (b)(6) 2019.The primary investigator (pi) assessed this event as not related to the interventional procedure, ekos system, or thrombolytic and probably related to anticoagulant drug.On 26 september 2019, btg became aware that the medical monitor (mm) reassessed the sae as probably related to interventional procedure and ekos system and not related to thrombolytic and anticoagulants drugs.

• 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: 9240147
• MDR Text Key: 177642038
• Report Number: 3001627457-2019-00036
• 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: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/26/2019
• Initial Date FDA Received: 10/25/2019
• 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
• Patient Age: 66 YR