MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC®; CATHETER, CONTINUOUS FLUSH

Model Number 6779-007

Device Problems Failure to Advance (2524); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2021

Event Type  malfunction  

Event Description

Md was exchanging the ekos infusion catheter and found the wire would not pass through the new catheter and the coolant port was not functioning.The catheter was removed and replaced with a different infusion catheter without incident or harm to the patient.

• Brand Name: EKOSONIC®
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 13203631
• MDR Text Key: 283483358
• Report Number: 13203631
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6779-007
• Device Catalogue Number: 500-55150
• Device Lot Number: 190326008-004
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/27/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other