MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemoptysis (1887); Perforation of Vessels (2135)

Event Date 06/16/2018

Event Type  Injury  

Manufacturer Narrative

The guidewire is not a component of the ekos device, however the guidewire was used to place the ekos device during the procedure.There was no malfunction of the ekos device.The vessel perforation by the guidewire during placement of the ekos device is considered a user error related to the procedure.The hemoptysis lead to the removal of the ekos device and altered the patient's treatment.The patient's final outcome was reported to be "great".The guidewire used during the procedure is unknown.The type of guidewire used during ekos placement is at the discretion of the physician.'vessel perforation or rupture' is listed as a potential complication in the instructions for use.

Event Description

On 16 jun 2018, information was received regarding a patient undergoing ekos therapy for a bilateral pulmonary embolism.The first ekos catheter was placed in the rpa (right pulmonary artery), then during placement of the second ekos catheter the patient began coughing up blood.The physician immediately removed both catheters.After 5-10 minutes, the patient stopped coughing up blood and remained stable.The physician spoke with the pulmonologist and recommended a chest ct without contrast be performed.It was reported that the physician felt the guidewire may have perforated one of the vessels in the pulmonary vasculature.Additional information received on (b)(6) 2018 reported that the physician confirmed that a vessel was perforated most likely by the guidewire.The patient stopped coughing up blood and the chest ct was performed with normal results.The patient was receiving heparin as of (b)(6) 2018 and was reported as doing great.The patient was projected to be discharged from the hospital in 2-3 days.

• 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: 7683534
• MDR Text Key: 113869701
• Report Number: 3001627457-2018-00022
• 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,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other