MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER; CATHETER, CONTINUOUS FLUSH

Catalog Number 500-56112

Device Problem Device Inoperable (1663)

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

Event Date 03/24/2017

Event Type  malfunction  

Manufacturer Narrative

Both catheters (sn: (b)(4)) were returned to ekos for evaluation on 4/17/17.Ekos qa found that drug lumens on both iddcs (part of the catheter) contained blood and appeared to be occluded with blood.For the catheter with sn: (b)(4), the iddc (part of the catheter) was kinked and some fibrous material was present, and all drug holes in the iddc being occluded by blood and fibrous material.Ekos qa was unable to infuse fluids through the drug holes.For the catheter with sn: (b)(4), the evaluation found all drug holes in the iddc (part of the catheter) were also occluded by blood.Ekos qa was unable to infuse fluids through the drug holes.Delay in connecting the catheters to the infusion pump after the catheter replacement could have likely contributed to the instances.Delayed connection allows blood to back up in the iddc lumen and occlude drug infusion holes.However ekos was not able to determine the root cause of the instance as the customer reported.Device history record of both catheters was reviewed, and it shows that both catheters were manufactured per standard processes and met all acceptance criteria.

Event Description

Two 135cm / 12cm ekosonic catheters (sn: (b)(4)) were used to treat a patient with pulmonary embolism on (b)(6) 2017.Downstream occlusion alarm (s) occurred at drug port when the catheters were placed into the patient.Trouble shooting was performed and did not resolve the alarm, then the treating physician replaced the ekosonic catheters with standard infusion catheter(s).The treatment was completed, and the patient was doing well.This mdr is to respond to the customer filed mdr (mdr number: (b)(4)).

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: mei huang ; 11911 north creek parkway s; bothell, WA 98011-8809 ; 4254153180
• MDR Report Key: 6544328
• MDR Text Key: 74418882
• Report Number: 3001627457-2017-00015
• Device Sequence Number: 1
• Product Code: KRA
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/18/2019
• Device Catalogue Number: 500-56112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2017
• Initial Date FDA Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2017
• 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
• Treatment: EKOSONIC CATHETER SERIAL # (B)(4)
• Patient Age: 50 YR
• Patient Weight: 150