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 Hemoptysis (1887); Perforation of Vessels (2135)

Event Type  Injury  

Manufacturer Narrative

This event was not reported at the time it occurred six months ago.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.Vessel perforation is a known potential complication of this procedure listed in the instructions for use.Limited information was received.If additional information is received, a follow up report will be submitted.

Event Description

Limited information was received reporting that ekos was used to treat a patient six months ago and the patient experienced hemoptysis following the procedure.The procedure date and type was not reported.The physician reported that he believes the ekos catheter punctured the vessel wall.The physician stated that he did not puncture the vessel wall with the guidewire prior to placing the ekos catheter.The intervention required was not reported, but it was confirmed that the patient did not die as a result of this event.

• 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: 7491787
• MDR Text Key: 107513830
• Report Number: 3001627457-2018-00017
• 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: 04/16/2018

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: 04/16/2018
• 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): Life Threatening; Other; Required Intervention