MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number	500-55118
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for investigation on 3 september 2019.The reported catheter leak was confirmed in the investigation.A crack in the intelligent drug delivery catheter (iddc) tubing drug lumen was observed underneath the strain relief where loctite from the manifold had wicked onto the tubing.A capa has been opened to investigate this failure mode and it will continue to be monitored through the capa process and complaint metrics and trending.The catheter was being placed to treat pulmonary embolism.The patient received the targeted amount of lytic and was reported to be stable.While no patient impact or adverse event was reported, the patient underwent a second procedure to replace the device to treat this pe.Review of the device history record confirmed that the product was manufactured per standard processes and met all acceptance criteria.There have been no other reported complaints from msds of the same lot.
Event or Problem Description
Ekos distributor reported that after 12 hours of treatment, the catheter was replaced due to a leak from the drug lumen.The catheter was being placed to treat a pulmonary embolism (pe).The patient received the targeted amount of lytic and was reported to be stable.While no patient impact or adverse event was reported, the patient underwent a second procedure to replace the device for pe treatment.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Common Device Name: EKOSONIC ENDOVASCULAR CATHETER
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• MDR Report Key: 9100898
• Report Number: 3001627457-2019-00026
• Device Sequence Number: 2665409
• Product Code: KRA
• UDI-Device Identifier: 00858593006141
• UDI-Public: 00858593006141
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K182324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2019

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: 06/30/2022
• Device Model Number: 500-55118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2019
• Initial Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1