MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number 500-56140

Device Problem Audible Prompt/Feedback Problem (4020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the manufacturer and investigations on 09 december 2019 showed a short in an msd element that appeared to cause a burn in the coolant shaft.The burn did not completely melt through the lumen and there was no communication between any of the drug lumens and the coolant lumen.The device short was not reported by the user.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.No patient harm was reported.The customer stated the temperature alarm occurred on the third day of treatment.The ifu states ""cumulative ultrasound therapy time should be limited to 24 hours per device." 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, ekos distributor reported an event that on the third day of treatment, temperature too high sign was noticed on the control unit (cu).The customer flushed the catheter per hospital's protocol but could not resolve the alarm.The sign was still showing.No other information was provided.There were no patient consequences reported.The device was returned to the manufacturer and investigations on 09 december 2019 showed a short in an microsonic device (msd) element that appeared to cause a burn in the coolant shaft.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: 9469751
• MDR Text Key: 209268711
• Report Number: 3001627457-2019-00045
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006301
• UDI-Public: 00858593006301
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K182324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 500-56140
• Device Catalogue Number: 500-56140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Date Manufacturer Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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