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

Device Problems Electrical /Electronic Property Problem (1198); Temperature Problem (3022)

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

Event Date 06/10/2022

Event Type  Injury  

Event Description

It was reported that troubleshooting was unable to resolve the e311 alert.If the patient is brought back to the catheterization lab for catheter replacement, this is considered an additional intervention.An ekos catheter was selected for use.Therapy run time was 8 hours and 9 minutes.During the procedure, an e310 alarm displayed.All connections were verified and were secure.No bent pins or fluid ingress was observed.All connections were re-secured and the device is running with no alarm.The patient's status was fine.An e311 alarm was observed.All connections were verified and were secure.No bent pins or fluid ingress was observed.The connector interface cable (cic) was switched to a new channel and switched to a new cic; however, there was no resolution.The machine was power cycled and no resolution.It is unknown how the procedure was completed.There were no patient complications reported.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14944108
• MDR Text Key: 295405832
• Report Number: 2134265-2022-07496
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/07/2022

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 07/07/2022
• 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