MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number 500-55112

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

Patient Problem Thrombus (2101)

Event Date 08/13/2019

Event Type  Injury  

Manufacturer Narrative

The site reported the patient experienced a new pe, lower extremity dvt.Per the principle investigator (treating physician) the event was not related to interventional procedure, ekos system, thrombolytic drug and unknown to anticoagulant drug.However, the study safety monitor assessed the event as probably related to the interventional procedure but not to ekos system, thrombolytic or anticoagulant drug.No device malfunction was reported for either of the two devices used in the case.There were two devices with serial numbers (b)(4) used during the case.This mdr is for the second device with serial number (b)(4).Mdr for the first device was submitted under mfr # 3001627457-2019-00033.No additional information will be available.

Event Description

On 05 september 2019, a clinical study sae was reported for subject (b)(6).The (b)(6) caucasian male is enrolled in (b)(6) study and was treated for a bilateral pe on (b)(6) 2019.The site documented the serious adverse event as a pe, lower extremity dvt on (b)(6) 2019.The patient had shortness of breath and was hospitalized.The event was assessed by the principal investigator as not related to interventional procedure, ekos system, or thrombolytic drug; and with an unknown relationship to anticoagulant drug.The event reportedly is ongoing.There were two devices used for the bilateral procedure and no devices malfunctions were reported.The event was reviewed by the study safety monitor using the svs guidelines.Per the safety monitor, the source documents indicate radiographic imaging suggestive of a fair amount of residual thrombus (which was known to be present at the end of the index procedure), but no clear evidence of new.This thrombus burden is decreased in volume compared to his pre-op ct scan.Based on the design and underlying purpose of the ekos system, she considered incomplete thrombus removal to be more of a procedure-related event than a catheter (device)-related event.The safety monitor assessed the event as probably related to the interventional procedure but not to ekos system, thrombolytic or anticoagulant drug.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Type of Device: EKOSONIC ENDOVASCULAR CATHETER
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• Manufacturer (Section G): EKOS CORPORATION; 11911 north creek parkway; bothell WA 98011 8809
• Manufacturer Contact: sandara bausback-aballo ; 300 conshohocken state rd,; 300 four falls corporate ctr.; west conshohocken, PA 19428-2998 ; 6103311537
• MDR Report Key: 9152670
• MDR Text Key: 165425330
• Report Number: 3001627457-2019-00034
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006134
• UDI-Public: 00858593006134
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2002
• Device Model Number: 500-55112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2019
• 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): Other; Required Intervention
• Patient Age: 69 YR