MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH

Lot Number 0029874869

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Tamponade (2226)

Event Date 09/29/2022

Event Type  Injury  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

During a brockenbrough procedure, a polarsheath was selected for use.It was reported that a polarx balloon and a polarmap catheter were placed in the polarsheath, and a premap was performed with the map catheter.After premapping, the ablation was attempted in the left superior pulmonary vein (lspv), but the patient's blood pressure was low (150 in normal times, around 50 in abnormal times).An echocardiogram immediately confirmed the presence of blood in the pericardial cavity, which was diagnosed as cardiac tamponade.An echocardiogram was used to find a hole, but it could not be confirmed, and as a result, a pericardial puncture was performed.The blood could no longer be drawn, and the patient's blood pressure returned to around 100.After observing the situation for a while, hemostasis was performed.The procedure was not completed.

• Brand Name: POLARSHEATH
• Manufacturer (Section D): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15657818
• MDR Text Key: 302266785
• Report Number: 2124215-2022-42866
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2023
• Device Lot Number: 0029874869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention