MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number UNKNOWN

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

Patient Problems Death (1802); Hemothorax (1896)

Event Type  Death  

Manufacturer Narrative

Limited information was published regarding the retrospective in-hospital death due to massive hemothorax.No "paitent" or procedure specific information was published.The massive hemothorax was identified during autopsy.Based on the information available, the cause and relationship to the ekos device and procedure is unknown.No additional information is expected.(b)(4).

Event Description

The following publication containing safety events was reviewed on 26 nov 2018: title: ultrasound-assisted catheter-directed thrombolysis compared with anticoagulation alone for treatment of intermediate-risk pulmonary embolism authors: andrew j.Schissler, robert j.Gylnn, piotr s.Sobieszczyk and aaron b.Waxman facility: (b)(6) hospital/(b)(6) medical school.This study sought to evaluate any lasting advantage of uacdt (ultrasound-assisted catheter-directed thrombolysis) on mortality and resolution of rv dysfunction in intermediate-risk pe at a large academic medical center.Adults aged <86 years admitted with intermediate risk pe from 2011 to 2016 were retrospectively identified.Outcomes including length of stay (los), bleeding complications, resolution of rv dysfunction, and mortality were compared between patients who received uacdt and those managed with anticoagulation alone.A total of 104 patients were included in the analysis, 65 of whom received uacdt.One "paitent" died before discharge in the uacdt cohort due to massive hemothorax confirmed on autopsy.All other safety events reported are considered to be unrelated to ekos.The relationship between the fatal massive hemothorax and the ekos device/procedure is unknown.

• 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: 8175046
• MDR Text Key: 130684636
• Report Number: 3001627457-2018-00039
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• 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: 11/26/2018
• 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): Death