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

Model Number	500-55106
Medical Device Problem Codes	Difficult to Flush (1251); Leak/Splash (1354); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a drug occlusion and leak occurred.An ekosonic catheter was selected for use during a lower extremity arterial thrombolysis procedure.Approximately 7 hours into therapy, blood was noted in the drug port.The lytic bag was changed an hour before.Troubleshooting was performed and a leak from the three way stopcock was noted.The nurse attempted to flush with a 3 cc syringe, but was unsuccessful.Back pressure was released and another flush was attempted for no resolution.At this time, the physician decided to send the patient back for recheck.No further information is known at this time.This report will be updated should additional information become available.

• Brand Name: EKOSONIC KIT 106CM 12CM TZ
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s.; bothell WA 98011
• MDR Report Key: 11984357
• Report Number: 2134265-2021-07541
• Device Sequence Number: 14575488
• Product Code: KRA
• UDI-Device Identifier: 00858593006028
• UDI-Public: 00858593006028
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K182324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/15/2023
• Device Model Number: 500-55106
• Device Catalogue Number: 500-55106
• Device Lot Number: 0011700105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/11/2021
• Patient Sequence Number: 1