MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number UNKNOWN

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

Patient Problem Blood Loss (2597)

Event Date 11/02/2018

Event Type  Injury  

Manufacturer Narrative

This was a query for guidance on therapy discontinuation.No relationship to ekos was reported.The source and cause of the internal bleeding was not reported.Based on the information available, the patient's internal bleeding is possibly the result of a post-surgical complication exacerbated by the thrombolytic, but without further details, the cause is unknown.Follow up attempts were made to obtain additional information, but no response was received.No additional information is expected.If additional information is received, a follow up report will be submitted.

Event Description

On (b)(6) 2018, a helpline call was received reporting that a patient was being treated with ekos for a dvt (duration of treatment and dosage of lytic was not reported).The caller requested guidance for the discontinuation of ekos therapy.It was reported that the patient was 3 days post hip surgery and that the ekos therapy was being discontinued because the patient was bleeding internally and would be taken to surgery.At the time of the call, the patient was reported to be stable.

• 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: 8122888
• MDR Text Key: 129025552
• Report Number: 3001627457-2018-00036
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2018
• 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): Required Intervention