MAUDE Adverse Event Report: BTG BOTHELL EKOSONIC KIT 106CM 12CM TZ; CATHETER, CONTINUOUS FLUSH

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

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Hemorrhage, Cerebral (1889); No Code Available (3191)

Event Date 04/01/2020

Event Type  Death  

Manufacturer Narrative

Beyer, s.E., sanafelt, c., pinto, d.S., weinstein, j.L., aronow, h.D., weinberg, i., carroll, b.J.(2020).Utilization and outcomes of thrombolytic.Utilization and outcomes of thrombolytic, chest(157), 645-653.

Event Description

Reported via journal article, bleeding requiring transfusion, surgical thrombectomy, and in hospital mortality occurred.The purpose of the article is to examine practice patterns of systemic thrombolysis and catheter-directed thrombolysis (cdt) and to compare outcomes following cdt with ultrasound facilitation (cdt-ultrasound) and cdt alone.Although various forms of catheter-directed thrombolysis (cdt) exist, the best studied and only device approved by the us food and drug administration for the management of pe is the ekosonic endovascular system (ekos).Although there were clear differences between patients receiving systemic thrombolysis and cdt, there were minimal differences in baseline patient characteristics and comorbidities between cdt-ultrasound and cdt alone.In addition, associated high-risk features of acute pe, including mechanical ventilation, hypotension, shock, and vasopressor utilization, were similar.We found no differences in bleeding, in-hospital mortality, or readmissions between cdt-ultrasound and cdt alone.Notably, the rate of major bleeding was similar to that seen in the seattle ii trial.Rates of intracranial hemorrhage were low, and they occurred in 0.6% of patients receiving cdt ultrasound.No further information is known regarding the patient events.

• Brand Name: EKOSONIC KIT 106CM 12CM TZ
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BTG BOTHELL; 11911 north creek parkway s.; bothell WA 98011 8809
• Manufacturer (Section G): BTG BOTHELL
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10079521
• MDR Text Key: 191714232
• Report Number: 2134265-2020-06842
• Device Sequence Number: 1
• Product Code: KRA
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• 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: 04/30/2020
• 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