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 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

Iddc and msd returned neatly coiled with the cables cut off and included in the packaging.Investigation on 06 january 2020 showed blood was present in the drug lumens and wavy wires were seen throughout.Tool marks were observed on the msd at 9.6cm, 18.5cm, 21.5cm, 26.5 cm, 31.4cm, 35.7cm, and 39.2cm distal to the strain relief.Shorts were observed at the strain relief and 31.3 cm distal to the strain relief.The device short was not reported by the user.Reperfusion pain in the patient's leg was reported by the nurse.It is a known common complication after achieving blood flow in peripheral arterial disease procedures, and it is not dependent on or related to the use of ekos ultrasound therapy.No definitive root cause could be identified.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.The customer reported that the physician had difficulty advancing the msd into the iddc.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 short.

Event Description

On (b)(6) 2019, 2 hours and 3 minutes into therapy, icu nurse called with a wa alarm.Ekos catheter was used to treat a unilateral right leg thrombus.Ekos representative went over troubleshooting steps with no avail.The representative recommended to replace the control unit.The patient was having leg pain and the nurse thought it was due to reperfusion.Another nurse called later and stated the alarm was "all groups disabled".He said the physician had difficulty advancing microsonic device (msd) into intelligent drug delivery catheter (iddc).Ekos representative advised him to use the catheter as either a catheter-directed thrombolysis (cdt) drip or to replace the catheter with another one.The nurse later called to inform that they had pulled the catheter and replaced it with a new one.The device was returned to the manufacturer and investigations on 06 january 2020 showed two shorts in the msd.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: 9598307
• MDR Text Key: 220829152
• Report Number: 3001627457-2020-00004
• 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: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 500-56150
• Device Catalogue Number: 500-56150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2020
• 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