MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number 500-55118

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

Patient Problem Thrombosis (2100)

Event Date 09/04/2017

Event Type  Injury  

Manufacturer Narrative

The patient developed vte (venous thromboembolism); arterial occlusion of the left lower extremity following "treatement" with ekos for a bilateral pe.The investigator assessed the vte (venous thromboembolism); arterial occlusion of the left lower extremity as serious and not related to the ekos device but probably related to the interventional procedure, thrombolytic drug and anticoagulant drug.The study's medical monitor assessed the sae as definitely related to the interventional procedure and not related to the ekos system, thrombolytic drug and anticoagulant drug.The btg physician is in agreement with the study's medical monitor.As the event is not related to the device, no investigation into the device history record is required.Distal embolization of blood clots is listed in the ifu as a potential complication [associated with the procedure].No additional information will be available.

Event Description

A (b)(6) female patient was treated with ekos for a bilateral pe on (b)(6) 2017 (duration and dose of treatment was not reported).The patient developed vte (venous thromboembolism); arterial occlusion of the left lower extremity on (b)(6) 2017.The patient required hospitalization and percutaneous thrombectomy.The sae resolved on (b)(6) 2017.This event was not reported to the manufacturer by the treating physician at the time of the event.This patient was enrolled in a retrospective study (b)(6) (subject (b)(6)).The investigator assessed the vte (venous thromboembolism); arterial occlusion of the left lower extremity as serious and not related to the ekos device but probably related to the interventional procedure, thrombolytic drug and anticoagulant drug.

• 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: 8217997
• MDR Text Key: 132099867
• Report Number: 3001627457-2019-00001
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006141
• UDI-Public: 00858593006141
• 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,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 500-55118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2017
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR