MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC MACH 4 ENDOVASCULAR DEVICE; CATHETER, CONTINUOUS FLUSH

Model Number EKOSONIC MACH 4

Device Problems Flushing Problem (1252); Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2020

Event Type  malfunction  

Event Description

Ekos catheter's coolant line failed to flush through the line.Line was occluded.Fda safety report id #: (b)(4).

• Brand Name: EKOSONIC MACH 4 ENDOVASCULAR DEVICE
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EKOS CORPORATION; bothell WA 98011
• MDR Report Key: 10179936
• MDR Text Key: 196202569
• Report Number: MW5095137
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2021
• Device Model Number: EKOSONIC MACH 4
• Device Catalogue Number: 500-56140
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 78