AcQMap 800500Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857042007296), received between Oct 2, 2020 and Oct 2, 2020 — 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. How this data works · Data updated Oct 13, 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.

• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HISTORY: A MALE PATIENT (AGE (B)(6); WEIGHT 22 BMI) WAS TREATED ON (B)(6) 2020. THE DE-NOVO ABLATION WAS USED TO TREAT THE PATIENT'S PAROXSYSMAL ATRIAL FIBRILLATION. IT IS UNKNOWN IF THE PATIENT WAS ON ANY MEDICATION PRIOR TO THE PROCEDURE. DESCRIPTION OF THE EVENT: AN ACUTUS REPRESENTATIVE ATTENDED THE PROCEDURE. IT WAS REPORTED THAT NORMAL PROCEDURAL STEPS BASED ON STANDARD OF CARE WERE UTILIZED TO ACCESS THE PATIENT'S LEFT ATRIUM. A TOTAL OF 5 MAPS WERE CREATED WITH THE ACQMAP CATHETER WITHOUT INCIDENT. A 6TH MAP WAS CREATED TO INFORM PULMONARY VEIN ISOLATION (PVI) STRATEGY. THE ABBOTT¿ TACTICATH¿ SENSOR ENABLED CATHETER WAS INTRODUCED INTO THE LEFT ATRIUM. PRIOR TO ABLATING, THE PHYSICIAN STATED THAT THE POSITION OF THE ABLATION CATHETER DID NOT APPEAR TO BE ALIGNED WITH THE ANATOMICAL MAP BUT CONTINUED TO PERFORM THE PVI ABLATION. AT THIS POINT THE PATIENT'S BLOOD PRESSURE DROPPED. A TRANSTHORACIC ECHOCARDIOGRAM CONFIRMED THAT A TAMPONADE OCCURRED. A SUBXIPHOID PERICARDIOCENTESIS WAS PERFORMED AND AN UNKNOWN AMOUNT OF BLOOD/FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. THE PERICARDIOCENTESIS STABILIZED THE PATIENT. PROTAMINE WAS THEN ADMINISTERED TO REVERSE THE EFFECTS

  Patient problems: Cardiac Tamponade

  MAUDE report 10623443 ↗