MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC; CATHETER, CONTINUOUS FLUSH

Model Number 6795-007

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem No Code Available (3191)

Event Date 11/16/2019

Event Type  malfunction  

Event Description

A middle-aged male past medical history of tobacco abuse, chronic obstructive pulmonary disease (copd) with right leg swelling and extensive right leg deep vein thrombosis (dvt).Catheter assisted thrombolysis (ekos) inserted in this patient.Medication instilled leaking around sheath.Ekos removed on the next day and found to have a hole in tubing.New ekos inserted and working well, discontinued on a few days later.The dvt was in the right lower extremity involving the common femoral, superficial femoral, up to vein as well as distal posterior tibial vein." pt had ekos placement to dissolve dvt.Typically ekos is removed within 24hrs.Pt had no improvement and was experiencing leaking around the sheath site.This leaking was thought to be the thrombolytic fluid that was supposed to dissolve clot.Pt ultimately had to return to surgery.It was found that there was a hole in the catheter causing the fluid not to reach the clot.A new ekos needed to be placed for 24hours".

• Brand Name: EKOSONIC
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EKOS CORPORATION; 11911 n. creek parkway south; bothell WA 98011
• MDR Report Key: 9382837
• MDR Text Key: 168234999
• Report Number: 9382837
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006318
• UDI-Public: (01)00858593006318
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6795-007
• Device Catalogue Number: 500-56150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Weight: 84