MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number UNKNOWN

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

Patient Problems Death (1802); Hemoptysis (1887); Perforation of Vessels (2135)

Event Date 04/10/2018

Event Type  Death  

Manufacturer Narrative

No device malfunction was reported.Perforation of the vessel with the ekos catheter into the airway is considered use error and resulted in serious injury and death.Vessel perforation is a known potential complication of this procedure listed in the instructions for use.It should be noted that the initial reporter was not the physician that treated this patient.Follow up was made with the treating physician on 16 april 2018 and limited information was received and has been reported.If additional information is received, a follow up report will be submitted.

Event Description

Two ekos devices were used to treat a patient with a bilateral pulmonary embolism (pe).Treatment was reported to be tpa 1 mg/hr bilateral for 4 hours.Upon removal of the ekos catheter, the patient experienced a massive hemoptysis.The treating physician reported that he believes that the ekos catheter perforated through the wall of the vessel and into the airway.After removal of the device, blood started leaking into the patient's airway.The treating physician felt that the elevated pulmonary artery (pa) pressures worsened the bleeding.The patient died soon after.

• 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: 7491268
• MDR Text Key: 107501285
• Report Number: 3001627457-2018-00016
• 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: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: No
• 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): Death