PULSED FIELD ABLATION CATHETER AND SHEATH

Report

• Report Number: MW5163642
• Event Type: Injury
• Date Received: December 12, 2024
• Date of Event: November 18, 2024
• Report Date: December 12, 2024
• Manufacturer: BOSTON SCIENTIFIC CORPORATION
• Product Code: QZI
• Adverse Event: Yes
• Report Source: Voluntary report
• Reporter Occupation: UNKNOWN
• Health Professional: *

Narratives

Description of Event or Problem · 0

IT WAS REPORTED THAT AFTER WITHDRAWING THE SHEATH FROM THE LEFT ATRIUM TO THE RIGHT ATRIUM THE PATIENT BECAME HYPOTENSIVE. ULTRASOUND WAS USED AND A PERICARDIAL EFFUSION WAS NOTED. A PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 520 CC OF FLUID WAS WITHDRAWN. THE PATIENT WAS THEN SENT TO SURGERY FOR FURTHER INTERVENTION. PATIENT CONDITION IS UNKNOWN AT THIS TIME. CARTO 34280 AND FARAWAVE GENERATOR USED. CARTO CATHETERS USED D160903, 10439236, AND R7D282CT. LOT NUMBERS UNKNOWN. CAS WILL RETURN D160903. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
239061	PULSED FIELD ABLATION CATHETER AND SHEATH	PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH	QZI	BOSTON SCIENTIFIC CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown		CARTO 34280.| CARTO CATHETER 10439236.| CARTO R7D282CT.| FARAWAVE GENERATOR.

Terms

Patient problem · 2

• Low Blood Pressure/ Hypotension
• Pericardial Effusion

Type of report · 1

• Initial submission