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 10/29/2019

Event Type  malfunction  

Manufacturer Narrative

The returned msd was evaluated on november 4th.Blistering was observed over many of the transducer elements.An apparent short was observed on one of the transducer elements and burned through the outer heat shrink.A bend in the msd was noted at 74.3 cm.A tool mark was noted 34.9 cm distal to the strain relief as well as a flattened section of the msd shaft at 18.7cm.The device short 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 short.

Event Description

On 28 october 2019, ekos distributor reported that after 24 hours therapy, temperature too high alarm (white c red thermometer icon) occurred.The catheter was flushed per hospital protocol.Temperature alarm was not resolved after flushing.The event log was not provided.There were no patient consequences reported.The device was returned to the manufacturer and investigations on 4 november 2019 showed a microsonic device (msd) short.This was not reported by the customer.While no patient impact, or adverse event was reported, serious injury could occur if this malfunction was to recur.

• 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: 9316977
• MDR Text Key: 216654113
• Report Number: 3001627457-2019-00040
• 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: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500-56150
• Device Catalogue Number: 500-56150
• Device Lot Number: 190214082-005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Date Manufacturer Received: 11/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2019
• 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