MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number UNKNOWN

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2015

Event Type  malfunction  

Manufacturer Narrative

A physical investigation could not be performed to determine the exact root cause because the device from this 2015 event was not made available.Review of the device history record could not be performed as the serial number was not provided.The leak was not reported at the time of occurrence.While no patient impact or adverse event was reported, the patient underwent a second procedure to replace the device.No additional information will be available.

Event Description

Hold smp 2.8 2)review it was reported that after catheter placement on a (b)(6) male patient undergoing a bilateral pe treatment on (b)(6) 2015, the right sided ekos catheter was noted to be leaking.This patient (subject id (b)(6) was enrolled in a retrospective knocout clinical trial.The patient was brought back to the angiography suite and the right ekos catheter was exchanged for a new ekos catheter over a rosen wire.The new catheter was connected, and no leaking was seen.All lines of the ekos catheter were flushed and flowed without evidence of obstruction.The treatment was completed successfully after approximately 15 hours and 17 minutes of ultrasound therapy.The patient was discharged from the hospital on (b)(6) 2015.The device failure was not reported to ekos at the time of occurrence on (b)(6) 2015.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Type of Device: EKOSONIC ENDOVASCULAR CATHETER
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s; bothell, wa
• Manufacturer (Section G): EKOS CORPORATION; 11911 north creek parkway; bothell, wa
• Manufacturer Contact: sandra bausback-aballo ; 300 conshohocken state rd,; 300 four falls corporate ctr.; west conshohocken, pa ; 3311537
• MDR Report Key: 9956365
• MDR Text Key: 240330622
• Report Number: 3001627457-2020-00010
• 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: health professional,study,use
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 03/20/2020
• Initial Date FDA Received: 04/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR