MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number 500-56140

Device Problems Bent (1059); Device Inoperable (1663); Device Handling Problem (3265)

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

Event Type  malfunction  

Manufacturer Narrative

The catheter (sn: (b)(4)) was returned to ekos on (b)(6) 2017 for evaluation.Examination of the catheter found the ultrasound core shaft was twisted.The infusion catheter (iddc) was bent and wires inside protruded out of the catheter wall.A definitive root cause could not be identified.Ekosonic endovascular device instructions for use states: do not deform or kink the ultrasound core during delivery into the infusion catheter.If the ultrasound core is kinked at any time, do not attempt to use it, as kinking may lead to degraded performance or fracture during use.Review of the manufacturing records indicates that the product was manufactured according to specification following all applicable procedures and the finished device met all acceptance criteria prior to release.

Event Description

A 135cm/40cm ekosonic catheter (sn: (b)(4)) was used to treat a patient with deep vein thrombosis, exact event date was not provided by the complainant.After successfully placing the infusion catheter (part of the ekosonic catheter) in the patient, the treating physician tried to place ultrasound core (micro sonic device), but the ultrasound core failed to advance inside the infusion catheter.The physician removed the ultrasound core and used ekos catheter as infusion catheter and completed the therapy, and the patient was ok.

Manufacturer Narrative

Follow up narrative/correction: the medical assessment for this event was re-reviewed and it was noted that details of the returned product evaluation were not included during the initial medical assessment.The evaluation of the returned catheter noted that the msd had pinch mark(s) which confirmed the 'msd would not advance" complaint.The iddc was noted to be stretched and wires in the iddc of catheter (sn (b)(4)) protruded out of the iddc wall.The evaluation included that the location was measured from the distal end of the strain relief, the distal marker band was out of round and moved distally 1 mm, chatter marks were noted from the marker band to 123 cm proximally, the tc wire was kinked/wavy, the proximal tc was 12 mm proximal of the proximal marker band, there was kinking in the tc/stiffening wire and wires were protruding from the outer drug wall at 47 cm.A follow up medical assessment was conducted on october 26, 2017.The conclusion that user handling caused or contributed to the event remains unchanged.After additional discussion, it was determined that the protruding wires are consistent with the catheter being stretched during removal and upon recoil (outside of the patient), the stiffening wires protruded out of the iddc wall.Considering the catheters flexible nature, a forward force would not have caused the stiffening wires to protrude through the iddc wall during catheter placement.Based on the investigation, it was determined that the protrusion of the stiffening wires occurred at catheter removal (outside of the patient) and therfore would not result in serious injury if the event were to recur.This event has been reassessed and is not considered a reportable device malfunction.

Event Description

This is a follow up report to correct the assessment made in the initial report.Refer to initial mdr 3001627457-2017-00023 for event description.

• 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: rachael weir ; 11911 north creek parkway s; bothell, WA 98011-8809 ; 7325878533
• MDR Report Key: 6714257
• MDR Text Key: 80057838
• Report Number: 3001627457-2017-00023
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006301
• UDI-Public: 00858593006301
• 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,Followup
• Report Date: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/10/2020
• Device Model Number: 500-56140
• Device Catalogue Number: 500-56140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2017
• 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