MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC KIT 106CM 12CM TZ; CATHETER, CONTINUOUS FLUSH

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

Patient Problems Bradycardia (1751); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is unknown; therefore, is approximated.Guliani, s., gupta, j.D., osofsky, r., marek, j., rana, m.A., & marinaro, j.(2020).Protocolized use of catheter-directed.Perfusion.Doi.Org/10.1177/0267659119896891.

Event Description

Literature review: it was reported that bradycardia, hypotension, and an intracranial hemorrhage occurred.In the journal article titled: protocolized use of catheter-directed thrombolysis and echocardiography is highly effective in reversing acute right heart dysfunction in severe sub-massive pulmonary embolism patients, a retrospective study was conducted on 28 patients that underwent catheter-assisted thrombolysis with the ekosonic catheter.The results of the study reported that one patient developed episodic bradycardia and hypotension 4 hours post thrombolysis initiation.This was due to catheter irritation in the pulmonary vasculature.Symptoms resolved upon removal of the catheter.Additionally, the article reports that one patient developed an intracranial hemorrhage 2 weeks after discharge, requiring re-admission.No further information is known at this time.

• Brand Name: EKOSONIC KIT 106CM 12CM TZ
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; bothell WA
• Manufacturer (Section G): BTG BOTHELL; bothell WA
• Manufacturer Contact: jay johnson
• MDR Report Key: 10080164
• MDR Text Key: 191742145
• Report Number: 2134265-2020-06834
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183361
• 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

• 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
• Initial Date Manufacturer Received: 04/29/2020
• Initial Date FDA Received: 05/21/2020
• 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): Required Intervention