MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC KIT 106CM 12CM TZ; CATHETER, CONTINUOUS FLUSH

Model Number 500-55112

Device Problems Device Alarm System (1012); Difficult to Flush (1251); Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2020

Event Type  malfunction  

Event Description

It was reported that a drug infusion alarm occurred and was unable to be resolved.An ekosonic catheter was selected for use during a bilateral pulmonary embolism thrombolysis procedure.Approximately 6 hours into therapy, fluid was noted to be leaking from the drug port connector on the catheter.Its was noted that an extension tubing was placed on the drug port of the catheter.This was removed under the direction of the clinical specialist and the iv line was connected directly to the drug port.At this time, a drug infusion pump alarm occurred.There flushes were performed with a 3cc syringe for no effect.Resistance while flushing was also observed.At this point, the physician decided to discontinue tpa and continue with normal saline and ultrasound.No patient complications were reported and the physician was happy with the results.

• Brand Name: EKOSONIC KIT 106CM 12CM 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 n. creek parkway s.; bothell WA 98011
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11120392
• MDR Text Key: 225282280
• Report Number: 2134265-2020-18708
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006134
• UDI-Public: 00858593006134
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183361
• 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: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2023
• Device Model Number: 500-55112
• Device Catalogue Number: 500-55112
• Device Lot Number: 0010776760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1