MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Catalog Number 500-56112

Device Problems Bent (1059); Fracture (1260); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2017

Event Type  malfunction  

Manufacturer Narrative

Catheter sn (b)(4) was returned to ekos and evaluated on (b)(6) 2017.Examination of the catheter found the ultrasound core wire (microsonic device, msd) shaft was damaged and twisted in a section between 4 cm and 15.5 cm from the proximal end of the strain relief.The msd damaged included a section where internal rf wires broke through the polyimide/stainless steel braided sheath tubing.Fractured material from the msd polyimide/stainless steel braided sheath tubing was found in the infusion catheter (iddc) coolant lumen at 55 mm, 82 mm, 90 mm, 96 mm from the distal end of the strain relief.A definitive root cause could not be identified.Ekosonic endovascular device instructions for use states: if an iddc or msd becomes kinked or otherwise damaged during use, discontinue use and replace.Do not deform or kink the msd during delivery into the iddc.If the msd is kinked at any time, do not attempt to use the msd, as kinking may lead to degraded performance or fracture during use.Review of manufacturing records indicated that the product was manufactured according to the specification following all applicable procedures and the finished device met all acceptance criteria prior to release.

Event Description

A 135 cm/12 cm ekosonic catheter was used to treat a patient with a pulmonary emboli on (b)(6) 2017.The infusion catheter (part of the ekosonic catheter) and ultrasound core wire (microsonic device, msd) were initially placed successfully in the patient.After 1 hour and 45 minutes of therapy, the control unit had a temperature alarm.The event log of the original control unit showed artificial temperature readings and it was requested to have the artificial catheter set returned.The catheter set was evaluated on (b)(6) 2017.It was found that the msd was damaged and twisted 4 cm-15.5 cm from the proximal end of the strain relief and the damage broke through the protective tubing and exposed some rf wires.Fractured material from the msd polyimide/stainless steel braided sheath tubing was found in the iddc coolant lumen.Update from the sales representative on 7/3/2017 stated the patient received a full dose of thrombolytics and is doing well.

• 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: sharon gundersen ; 11911 north creek parkway s; bothell, WA 98011-8809 ; 4254153100
• MDR Report Key: 6736683
• MDR Text Key: 80834965
• Report Number: 3001627457-2017-00024
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006264
• UDI-Public: 00858593006264
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/06/2020
• Device Catalogue Number: 500-56112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2017
• 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