MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number 500-56150

Device Problem Audible Prompt/Feedback Problem (4020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint catheter was returned, and the evaluation on (b)(6) 2019 showed that the braided tubing and a portion of the surrounding heat shrink distal of the strain relief was torn and the wires underneath were exposed.Blistering was observed over the msd's transducer elements and evidence of use seen throughout the catheter.A bend in the shaft at 90.0 cm and damage to the external sheath at the proximal end of the msd was noted.The device fracture was not reported by the user.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.No patient harm was reported.The ifu warns the user to not advance if resistance is met.Excessive force against resistance may result in damage to the device or vasculature.User error was not confirmed, but could not be ruled out as a contributing factor to the msd fracture.

Event Description

On (b)(6) 2019, 15 hours and 48 minutes into therapy, icu nurse called with the control unit (cu) alarming with a device temp too high alarm.The catheter was placed to treat bilateral dvt.Troubleshooting steps were unsuccessful in resolving the issue.The nurse informed that tpa had been off for 4 hours due to a drop in the fibrinogen level and no fluids were running to the lines.Ekos representative recommended to get an order to run maintenance fluids to prevent clotting in the line.The patient was reported as stable.The icu nurse called back and reported that he was able to flush the tpa lines with a little resistance.The coolant flowrate was 65ml/hr and cu was still alarming.They only had 2 cus on site, and both were running at the time.Twenty seven hours and forty minutes into therapy, the account called with another white c red thermometer alarm.Ekos representative checked for cross connection and bent pins or fluid ingress and none were noted.The patient had not been repositioned, the catheter had not been aspirated, and the dressing had not been tampered with.The tpa was stopped that morning per the physician orders due to high pt/ptt labs and had normal saline (ns) flowing through the drug port prior to the call.They did a power cycle on the cu for 5 mins.After rebooting the cu and reconnecting, the alarm cleared, and the cu started working.On (b)(6), investigation of the microsonic device (msd) found that the braided tubing and a portion of the surrounding heat shrink distal of the strain relief was torn and the wires underneath were exposed.This was not reported by the customer.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Type of Device: EKOSONIC ENDOVASCULAR CATHETER
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• Manufacturer (Section G): EKOS CORPORATION; 11911 north creek parkway; bothell WA 98011 8809
• Manufacturer Contact: sandara bausback-aballo ; 300 conshohocken state rd,; 300 four falls corporate ctr.; west conshohocken, PA 19428-2998 ; 6103311537
• MDR Report Key: 9281013
• MDR Text Key: 207123822
• Report Number: 3001627457-2019-00037
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006318
• UDI-Public: 00858593006318
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/07/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 500-56150
• Device Catalogue Number: 500-56150
• Device Lot Number: 190430101-004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 11/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2019
• 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