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 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

Microsonic device (msd) was returned neatly coiled and the investigation on 02 january 2020 showed slight blistering on an msd element.The 6th element of the 4th group appeared to have shorted.Review of the event log showed the system alarmed after 55 hours of therapy and continued over 9 more hours of therapy.The control unit was powered cycled multiple times and the therapy ended after 65 hours.The device was used over 24 hours which is not recommended per the ifu.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 ifu warns not to use the device over 24 hours.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 a device temperature too high alarm occurred after 2 days of therapy.The alarm persisted even after the infusion rate was increased to 80ml/hr and the control unit was switched.The patient was reported to be stable.The device was returned to the manufacturer and investigations on 02 january 2020 showed a short in one of the microsonic device (msd) element.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: 9598310
• MDR Text Key: 220827661
• Report Number: 3001627457-2020-00003
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006318
• UDI-Public: 00858593006318
• 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: 01/02/2020

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: 08/31/2022
• Device Model Number: 500-56150
• Device Catalogue Number: 500-56150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Initial Date Manufacturer Received: 01/02/2020
• Initial Date FDA Received: 01/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2019
• 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