MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number	500-55118
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	09/04/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: CATHETER
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• MDR Report Key: 8217997
• Report Number: 3001627457-2019-00001
• Device Sequence Number: 229304
• Product Code: KRA
• UDI-Device Identifier: 00858593006141
• UDI-Public: 00858593006141
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K140151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 500-55118
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 68 YR