MAUDE Adverse Event Report: BOSTON SCIENTIFIC POLARIS X; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 11/04/2016

Event Type  Injury  

Event Description

It was reported that a complication occurred while placing the boston scientific polaris in the coronary sinus.A pericardial effusion was noticed as the patient's blood pressure slowly began to drop.It was confirmed by ultrasound.Caller reported that the medical intervention provided was a pericardiocentesis and 200 cc of fluid were removed.Caller was reported to be in stable condition.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: POLARIS X
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 17532883
• MDR Text Key: 321154622
• Report Number: MW5139789
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1