Blazer™ Dx-20 M00420SL2820Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729780519), received between Dec 4, 2019 and Dec 4, 2019 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CARDIAC TAMPONADE AND EFFUSION. DURING AN ABLATION PROCEDURE TO TREAT ATRIAL TACHYCARDIA, AFTER PLACING THE CATHETERS IN THE CORONARY SINUS (CS), "HRA", "HIS", RIGHT VENTRICLE (RV) AND "HALO," MAPPING WAS PERFORMED WITH AN INTELLAMAP ORION CATHETER, AND RADIOFREQUENCY (RF) ABLATION WAS PERFORMED USING AN INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER. A BLAZER DX CATHETER WAS PLACED RIGHT ATRIUM VENTRICULAR FREE-WALL SIDE, AND UNDERWENT AN ELECTROPHYSIOLOGY STUDY (EPS). FOUR OTHER NON-BOSTON SCIENTIFIC CATHETERS WERE ALSO USED DURING THE PROCEDURE. AFTER THE PROCEDURE, WHEN THE INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER WAS COMPLETELY PULLED OUT FROM THE PATIENT'S BODY, AND HEMOSTASIS WAS PERFORMED AT THE GROIN, THE PATIENT'S BLOOD PRESSURE DROPPED RAPIDLY. A CARDIAC TAMPONADE WAS OBSERVED BY ECHOCARDIOGRAM, SO PERICARDIAL DRAINAGE WAS PERFORMED. ALTHOUGH THE PHYSICIAN DID NOT KNOW THE CAUSE OF THE EFFUSION, THERE WAS POSSIBILITY THAT PERFORATION MIGHT HAVE BEEN CAUSED BECAUSE THE ATRIAL WALL ON ABLATION SITE WAS THIN. IT WAS UNKNOWN WHICH CATHETER CAUSED OR CONTRIBUTED TO THE EVENT. NO RESISTANCE WAS FELT WHILE MANEUVERING THE

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 9410676 ↗