MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC KIT 106CM 24CM TZ; CATHETER, CONTINUOUS FLUSH

Model Number 500-55124

Device Problem Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2020

Event Type  malfunction  

Manufacturer Narrative

Reported lot number: 190422017-002, could not be verified.

Event Description

It was reported that there was a white c- blue thermometer alarm on the initial 106cm/24cm catheter.The customer and company representative were unable to resolve the alarm through troubleshooting.The patient was unable to receive ultrasound therapy from the initial 106cm/24cm catheter.The physician was informed by the company representative that the catheter could be used as an infusion catheter or the catheter could be replaced with a new device.The patient was brought back to the lab for catheter replacement.There was no patient complications reported.It was reported that the patient was doing well.

• Brand Name: EKOSONIC KIT 106CM 24CM TZ
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s.; bothell WA 98011
• Manufacturer (Section G): EKOS CORPORATION; 11911 north creek pkwy south; bothell WA 98011
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10393259
• MDR Text Key: 202520235
• Report Number: 2134265-2020-10440
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500-55124
• Device Catalogue Number: 500-55124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2020
• 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