MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number 500-55140

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 01/22/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint catheter was returned on 30 jan 2019, and the evaluation confirmed heat being generated from the black hub at the covering of the luer barb (where the coolant port, drug infusion port, and electrical connector meet) consistent with the reported complaint.Fluid ingress was noted in the msd hub/housing.Msd x-rays showed signs of a short in the wires potted within the black hub.On (b)(6) 2019, the msd hub was dissected for further evaluation.The msd wires were exposed in some areas, through the heat shrink covering the solder joints, and was noted to be burned which is consistent with an electrical short.The event log shows therapy beginning on (b)(6) 2019 with the returned device sn: (b)(4).At 18.2 hours a no_groups_enabled alarm was seen due to all of the msd group's auto throttling power at this time.The alarm was cleared and the cu ran for a total of 86.1 hours without any additional alarms.A review of the device history record confirmed that the product was manufactured per standard processes and met all acceptance criteria and design intent.There have been no other reported complaints from msds of the same lot.The likely cause of the msd short was fluid ingress into msd hub/housing.This electrical short caused excessive heat.The msd hub/housing was layered against the patient's skin resulting in a skin burn.

Event Description

On (b)(6) 2019, it was reported that a patient was being treated with ekos for a dvt and experienced a skin burn as a result of the device.The patient was treated for 3 days and it was reported that the user changed out the catheters per protocol.However, on (b)(6) 2019 when they went to check on patient, the patient had developed a burn on his leg where the ekos catheter was placed.Upon observing the catheter, they noted that the housing hub was very hot.It was reported that the heat from the housing hub had layed against the patient's skin all night and caused a significant burn blister.There were no alarms at any time.The patient was reported as doing well except for the burn.The device was returned for evaluation.

Manufacturer Narrative

This is a follow up #1 report to update the event log information reported.The event log data shows the therapy beginning on 1/20/2019 with the returned device sn: (b)(4) for at least 37 hours.However, phase angle for group 2 and 5 went above threshold 35 degree intermittently during last 8 hours of the therapy which may indicate the transducers are wearing out or may indicate the short.The control unit performed as expected.

Event Description

This is a follow up report #1 to update information reported in h.10.Refer to initial report 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
• MDR Report Key: 8355283
• MDR Text Key: 139993268
• Report Number: 3001627457-2019-00004
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006172
• UDI-Public: 00858593006172
• Combination Product (y/n): N
• PMA/PMN Number: K182324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 500-55140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Date Manufacturer Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other