MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Catalog Number 500-55150

Device Problem Electrical Shorting (2926)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

The device was returned to ekos and evaluated on 10 jan 2018.Evaluation of the returned msd revealed evidence of shorted wires.The iddc was in used condition but no damage was observed.Evaluation conclusion - the root cause of the shorted wires was not identified.A review of the device history record for the msd confirmed that the product was manufactured per standard processes and met all acceptance criteria.No patient impact was reported.The damage did not affect the iddc and therefore did not come into contact with the patient's vasculature.The event did not impact the delivery of thrombolytic therapy.No serious injury occurred as a result of this malfunction.The control unit event log recorded that ultrasound was delivered for a total of 24.9 hours.

Event Description

On (b)(6) 2017, a helpline call reported a temperature alarm after 16 hours and 40 minutes of therapy.The alarm was resolved over the phone with the ekos representative by increase the coolant rate through the device.The device was returned to ekos for evaluation.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• Manufacturer (Section G): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• Manufacturer Contact: sandra bausback ; 300 four falls corp. center; 300 conshohocken st rd, # 300; west conshohocken, PA 19428-2998 ; 6103311537
• MDR Report Key: 7254802
• MDR Text Key: 99928481
• Report Number: 3001627457-2018-00004
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006189
• UDI-Public: 00858593006189
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/09/2020
• Device Catalogue Number: 500-55150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2017
• 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