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 Problems Dyspnea (1816); Hypoxia (1918)

Event Date 07/20/2019

Event Type  Injury  

Manufacturer Narrative

The site reported the patient experienced shortness of breath and hypoxema.Originally, the serious adverse event was assessed as not related to procedure or device but was later updated to unknown to the procedure and ekos system.The relatedness was changed a third time to unknown for the procedure and ekos system.The event resolved in two days.The site did not provide the type of treatment provided to resolve the shortness of breath.There were no device malfunctions reported.Review of the manufacturing records confirmed the catheter was manufactured according to existing specifications.No additional information will be available.

Event Description

Subject (b)(6) is a prospective patient enrolled in (b)(6).This patient is a (b)(6) caucasian male who was treated for a bilateral pe on (b)(6) 2019.The patient experienced shortness of breath on (b)(6) 2019, two days after the ekos procedure.Cta showed a potential increase in clot burden.The patient was treated with a competitor device a 2nd time and recovered on (b)(6) 2019.The shortness of breath was originally assessed as not related to procedure or device but was later updated to definitely to the procedure and probably to eko system.The assessment was changed a third time to unknown to the procedure and ekos system.The principle investigator classified this event as "dizziness increased sob hypoxema".The relationship was finally assessed as unknown the procedure and ekos system and no to 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: 9079950
• MDR Text Key: 163130101
• Report Number: 3001627457-2019-00025
• 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: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 500-55112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2019
• 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: 61 YR