MAUDE Adverse Event Report: EKOS CORPORATION; CATHETER, CONTINUOUS FLUSH

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

Patient Problems Pain (1994); Swelling (2091); Blood Loss (2597)

Event Date 03/01/2020

Event Type  Injury  

Manufacturer Narrative

Lichtenberg, michael k.W., et al.Endovascular mechanical thrombectomy versus thrombolysis in patients with iliofemoral deep vein thrombosis, a systematic review and meta analysis.Vasa, 2020, pp.1:9., doi:10.1024/0301-1526/a000875.Date of event was approximated based on submission date of article.

Event Description

Per literature article "endovascular mechanical thrombectomy versus thrombolysis in patients with iliofemoral deep vein thrombosis, a systematic review and meta analysis" it was reported that major bleeding and post-thrombotic syndrome occurred post ultrasound assisted catheter directed thrombolysis (ua cdt).A meta-analysis was performed to compare effectiveness and safety of percutaneous mechanical thrombectomy (pmt) and thrombolysis alone (thr) in patients with acute or subacute iliofemoral deep vein thrombosis (ifdvt).Ultrasound assisted catheter directed thrombolysis (ua cdt) was referenced within the study.Four major bleeding incidents after iliofemoral deep vein thrombosis with ua cdt were noted to have occurred.Pain and swelling are associated with post-thrombotic syndrome.No further information is known at this time.

• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s.; bothell WA 98011
• Manufacturer (Section G): EKOS CORPORATION; 11911 north creek pkwy south; bothell WA 98011
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10473457
• MDR Text Key: 205012537
• Report Number: 2134265-2020-11818
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other