AcQMap 900003Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00857042007029), received between Jan 13, 2020 and Jun 4, 2021 — classified as 5 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019 A BIOSENSE WEBSTER PREFACE SHEATH WAS USED TO GUIDE THE ABBOTT (B)(4) 71CM NEEDLE TO THE TRANSSEPTAL PUNCTURE SITE WHERE A SINGLE TRANSSEPTAL PUNCTURE WAS PERFORMED. THE ACQGUIDE SHEATH WAS THEN EXCHANGED VIA A GUIDEWIRE. THE ACQGUIDE SHEATH AND ACHIEVE GUIDEWIRE WERE USED TO POSITION THE ABLATION CATHETER FOR PVI. THE ABLATION CATHETER USED WAS AN ARCTIC FRONT BALLOON CATHETER. ISOLATION OF THE LUPV AND LLPV WAS ACHIEVED WITHOUT ISSUE. THERE WERE SOME ISSUES IN GAINING ACCESS TO THE RUPV WITH THE ACHIEVE GUIDEWIRE. TO ALLOW GREATER REACH WITHIN THE ACQGUIDE SHEATH, THE SLEEVE WAS CUT OFF THE ABLATION CATHETER PROVIDING ACCESS TO SUCCESSFULLY ISOLATE BOTH THE RUPV AND RLPV. THE ABLATION CATHETER WAS REMOVED AND THE ACQMAP CATHETER WAS PREPARED PER IFU. THE ACQMAP WAS THEN INSERTED TO THE LA VIA THE ACQGUIDE SHEATH. INITIAL RESPIRATORY COMPENSATION AND SYSTEM SET UP WAS COMPLETED WITHOUT ISSUE. USING ULTRASOUND, SEVERAL ATTEMPTS (APPROXIMATELY 3-4) WERE MADE TO CENTER THE ACQMAP CATHETER IN THE LA, BUT IT PROVED DIFFICULT WITH THE CATHETER SITTING HIGH AND NEAR THE ANTERIOR ROOF AND BASE OF THE LAA. A SINGLE ATTEMPT WAS MADE TO BETTER CENTER THE ACQMAP CATHETER BY PUL

  Patient problems: Pericardial Effusion; Thromboembolism

  MAUDE report 11942587 ↗
• InjurySep 11, 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 (B)(6) KG) WAS TREATED ON (B)(6) 2020. THE DE-NOVO ABLATION WAS USED TO TREAT THE PATIENT'S PAROXSYSMAL ATRIAL FIBRILLATION. THE PATIENT HAD BEEN PRESCRIBED FLECANIDE FOR THE PAROXYSMAL ATRIAL FIBRILLATION. DESCRIPTION OF THE EVENT: IT WAS REPORTED THAT THE BI-ATRIAL PROCEDURAL STEPS BASED ON STANDARD OF CARE WERE UTILIZED TO ACCESS THE PATIENT'S RIGHT AND LEFT ATRIUMS. NOTE: THE BI-ATRIAL USE OF TWO ACQMAP CATHETERS IS ONLY APPROVED IN EUROPE. THE BI-ATRIAL PROCEDURE TYPICALLY REQUIRES TWO TRANSSEPTAL PUNCTURES. HOWEVER, DURING THIS CASE ONLY ONE TRANSSEPTAL PUNCTURE WAS REQUIRED. IT WAS SUSPECTED THAT THE SECOND GUIDEWIRE WAS PLACED IN A FORAMEN OVALE, HOWEVER A TRANSOESOPHAGEAL ECHOCARDIOGRAM AND TRANSTHORACIC ECHOCARDIOGRAM COULD NOT CONFIRM THE GUIDEWIRE PLACEMENT. THE ACQMAP CATHETER AND THE ACQGUIDE STEERABLE SHEATH WERE POSITIONED IN THE RIGHT ATRIUM WHERE A MAP WAS CREATED, AND ABLATIONS WERE PERFORMED WITH THE ABBOTT¿ TACTICATH¿ SENSOR ENABLED CATHETER WITHOUT INCIDENT. THE ACQMAP CATHETER WAS THEN POSITIONED IN THE RIGHT ATRIUM/SUPERIOR VENA CAVA JUNCTION WHILE A SECOND ACQMAP CATHETER WAS PLACED INTO POSITION IN THE LE

  Patient problems: Pericardial Effusion

  MAUDE report 10525056 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HISTORY: A FEMALE PATIENT (AGE (B)(6); HEIGHT 166CM; WEIGHT (B)(6) KG) WAS TREATED ON (B)(6) 2020. THE PATIENT WAS BEING TREATED FOR ATRIAL TACHYCARDIA. DESCRIPTION OF THE EVENT: IT WAS REPORTED THAT THE PROCEDURAL STEPS BASED ON STANDARD OF CARE WERE UTILIZED TO ACCESS THE PATIENT'S RIGHT AND LEFT ATRIUM WITH THE ACQMAP MAPPING CATHETER AND THE ACQGUIDE STEERABLE SHEATH. DURING THE PROCEDURE THE TACTICATH SE D/F CURVE ABLATION CATHETER, (ABBOT LABS), WAS USED TO PACE THE LEFT ATRIAL APPENDAGE (LAA). AN AFOCUS II (ABBOTT LABS) WAS THEN INTRODUCED TO FACILITATE THE LAA PACING. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT OR PROCEDURAL COMPLICATION. AT THE TIME OF THE EVENT ALL CATHETERS AND SHEATHS HAD BEEN REMOVED FROM THE PATIENT. AFTER THE PROCEDURE WHILE THE PATIENT WAS WAITING TO BE TRANSFERRED TO THE RECOVERY AREA, THE PATIENT'S BLOOD PRESSURE DROPPED. A TRANSTHORACIC ECHOCARDIOGRAM CONFIRMED THE PRESENCE OF A CARDIAC TAMPONADE. A SUBXIPHOID PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 160 ML WAS REMOVED FROM THE PERICARDIAL SPACE. IN ADDITION, PROTAMINE WAS ADMINISTERED TO REVERSE THE EFFECTS OF HEPARIN ANTICOAGULANT. SURGICAL INTERVENTION WAS NOT NECESSARY T

  Patient problems: Cardiac Tamponade

  MAUDE report 9766175 ↗
• InjuryJan 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HISTORY: A FEMALE PATIENT (AGE = (B)(6); HEIGHT = 162 CM; WEIGHT = (B)(6) KG) WAS TREATED ON (B)(6) 2019. THE PATIENT WAS BEING TREATED FOR RUNS OF PREMATURE VENTRICULAR CONTRACTIONS (PVCS). IT WAS REPORTED THAT PROCEDURAL STEPS BASED ON STANDARD OF CARE WERE UTILIZED TO ACCESS THE PATIENT'S RIGHT VENTRICLE (RV) WITH THE ACQMAP MAPPING CATHETER AND THE ACQGUIDE STEERABLE SHEATH. DESCRIPTION OF THE EVENT: ALL DEVICES WERE PLACED FROM THE RIGHT ATRIUM INTO THE RV ACROSS THE TRICUSPID VALVE. WITH THE MAPPING CATHETER LOCATED IN A DESIRED POSITION, THE RV ANATOMY WAS CONSTRUCTED USING THE ACUTUS ACQMAP SYSTEM. AN ELECTRICAL RECORDING WAS ACQUIRED, AND THE RV ACTIVATION MAP WAS CREATED USING THE ACQMAP SYSTEM. THE TOTAL ACQMAP/ACQGUIDE DEVICE DWELL TIME WITHIN THE RV WAS APPROXIMATELY 55 MINUTES. BASED ON THE ACTIVATION MAP, THE PHYSICIAN INTERPRETED THE SITE OF CLINICAL INTEREST TO BE LOCATED MORE SUPERIORLY, WITHIN THE RV OUTFLOW TRACT (RVOT). THE PHYSICIAN ADVANCED THE TACTICATH ABLATION CATHETER (ABBOTT LABS) INTO A POSTERO-SUPERIOR POSITION WITHIN THE RVOT AND IDENTIFIED SIGNALS THAT CONFIRMED THE INTERPRETATION FROM THE ACTIVATION MAP. THE PHYSICIAN ELECTED TO REPOSITION T

  Patient problems: Cardiac Tamponade

  MAUDE report 9597904 ↗
• InjuryJan 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 11 DEC 2019 IT WAS REPORTED THAT STANDARD PROCEDURAL SETUP INCLUDING STANDARD TRANSSEPTAL PUNCTURE AND PULMONARY VEIN ANGIOGRAPHY WERE PERFORMED. THE ULTRASOUND ANATOMY RECONSTRUCTION AND ATRIAL FIBRILLATION BASELINE WAS RECORDED BY THE ACUTUS ACQMAP SYSTEM. SEVERAL ATTEMPTS AT DIRECT CURRENT CARDIOVERSION (DCCV) TO SINUS RHYTHM WERE UNSUCCESSFUL. THE PHYSICIAN THEN DECIDED TO ABLATE THE ANTEROSEPTAL LINE AND POSTERIOR LINE. ABLATION WAS CONDUCTED FROM THE MIDDLE VEIN LINE TO THE LEFT INFERIOR PULMONARY VEIN. AN ADDITIONAL DCCV ATTEMPT WAS UNSUCCESSFUL. EXTENSIVE ABLATION WAS PERFORMED FROM THE ANTERIOR LINE TO THE BASE OF THE LEFT ATRIAL APPENDAGE AND THE POSTERIOR LINE. AN ADDITIONAL DCCV ATTEMPT WAS UNSUCCESSFUL. THE ABLATION CATHETER WAS MOVED INTO THE AGILIS SHEATH AND BOTH CATHETERS WERE MOVED INTO THE RIGHT ATRIUM (RA). CORONARY SINUS ANGIOGRAPHY WAS PERFORMED AND ABLATION IN THE CORONARY SINUS WAS COMPLETED. AN ANATOMY OF THE RA WAS RECONSTRUCTED USING THE ACUTUS ACQMAP SYSTEM AND A MAP WAS CREATED. THE ACQMAP CATHETER WAS RETRACTED INTO THE SHEATH AND REMAINED IN THE RA. AT THIS TIME THE PHYSICIAN MENTIONED THAT THE PATIENT'S BLOOD PRESSURE WAS DECREASING. AN ULTRASOUND

  Patient problems: Pericardial Effusion

  MAUDE report 9582957 ↗