NaviStar DS NS7TCF8L174HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10846835000603), received between Oct 4, 2018 and Dec 16, 2022 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN ATRIAL FLUTTER RIGHT (R-AFL) ABLATION PROCEDURE WITH A NAVISTAR¿ DS ELECTROPHYSIOLOGY CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. DURING A TYPICAL ATRIAL FLUTTER ABLATION, AN AUDIBLE STEAM POP OCCURRED DURING RADIOFREQUENCY. LATER DISCOVERED OF LOWER BLOOD PRESSURE WITH CARDIAC TAMPONADE. PERICARDIAL DRAINAGE TO RESTORE BLOOD PRESSURE AT NORMAL LEVELS. SINCE THE EVENT (CARDIAC TAMPONADE) IS LIFE THREATENING AND IT MIGHT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR IT COULD REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE. STEAM POP IS NOT CONSIDERED TO BE A DEVICE MALFUNCTION. STEAM POP IS AN EXPECTED PHYSIOLOGICAL PHENOMENON. THEREFORE, STEAM POP IS NOT MDR REPORTABLE.

  Patient problems: Cardiac Tamponade

  MAUDE report 15999685 ↗
• InjurySep 2, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT (B)(6) UNDERWENT AN ATRIOVENTRICULAR NODAL RE-ENTRANT TACHYCARDIA (AVNRT) WITH A NAVISTAR" DS ELECTROPHYSIOLOGY CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. AFTER THE AVNRT CASE WAS COMPLETED, A PERICARDIAL EFFUSION WAS NOTICED. THE PERICARDIAL EFFUSION WAS DISCOVERED WHEN THE PATIENTS BLOOD PRESSURE DROPPED. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ECHO. MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 425 CC OF FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THIS ADVERSE EVENT WAS DISCOVERED POST USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIANS OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT HE WAS UNSURE. THE PHYSICIAN THINKS IT COULD HAVE BEEN THE HIS OR CORONARY SINUS CATHETER PLACEMENT IN THIS PATIENT, SO PATIENT CONDITION. PERICARDIOCENTESIS TO DRAIN 425CC. PATIENT OUTCOME OF THE ADVERSE EVENT WAS THAT THE PATIENT FULLY RECOVERED (NO RESIDUAL EFFECTS). THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT OF 2 ADDITIONAL DAYS FOR STABILIZATION AND MONITORING. RELEVANT TESTS/LABORATORY DATA: HEMOGLOBIN 10.5; HE

  Patient problems: Cardiac Tamponade

  MAUDE report 12411956 ↗
• MalfunctionFeb 24, 2021Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A NAVISTAR¿ DS ELECTROPHYSIOLOGY CATHETER AND A CLOT ISSUE OCCURRED. IT WAS REPORTING THAT A LOT OF CLOTTING ON THE TIP OF THE NAVISTAR¿ DS ELECTROPHYSIOLOGY CATHETER WAS OBSERVED AFTER THE ABLATION. PHYSICIAN CONSIDERED THE AMOUNT OF CLOT WAS EXCESSIVE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES OCCURRED. PATIENT DID NOT EXHIBIT ANY NEUROLOGICAL SYMPTOM SINCE THE PROCEDURE WAS COMPLETED. NO ERROR MESSAGE WAS OBSERVED. NO ISSUES RELATED TO TEMPERATURE NOR FLOW WERE REPORTED. THE GENERATOR WAS USED IN POWER CONTROL MODE AT 70 WATTS. THE TEMPERATURE CUT-OFF WAS AT 48 DEGREES. THE DURATION OF THE ABLATION WAS 120 SECONDS. HEPARINIZED NORMAL SALINE WAS USED AS IRRIGATION FLUID. THE CLOT ISSUE WAS ASSESSED AS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11370046 ↗
• MalfunctionOct 2, 2019Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAVOTRICUSPID ISTHMUS (CTI) LINE ABLATION PROCEDURE WITH A NAVISTAR¿ DS ELECTROPHYSIOLOGY CATHETER AND A COAGULATION ISSUE OCCURRED. IT WAS REPORTED THAT DURING ABLATION WITH THE NAVISTAR¿ DS ELECTROPHYSIOLOGY CATHETER A STEAM POP OCCURRED. NO ERRORS WERE SHOWN ON CARTO 3 SYSTEM AND NO IMPEDANCE RISE WAS NOTED. THE CATHETER TIP WAS CHECKED AND IT SHOWED SOME SMALL COAGULUM. THE CATHETER TIP WAS CLEANED, AND THE PROCEDURE WAS FINISHED WITHOUT ANY CONSEQUENCE TO THE PATIENT. ABSENCE OF PERICARDIAL EFFUSION WAS CONFIRMED BY ECHO. THE PHYSICIAN DID NOT CONSIDER THAT THE CHAR WAS EXCESSIVE NOR THAT IT POSED POTENTIAL RISK TO THE PATIENT. THE PATIENT HAS NOT EXHIBITED ANY NEUROLOGICAL SYMPTOMS. THE SMARTABLATE GENERATOR WAS SET TO TEMPERATURE CONTROL MODE WITH ABLATION SETTINGS WERE 70 WATTS OF POWER, 70-60C CUT-OFF. ACTIVATED CLOTTING TIME (ACT) OF ABOVE 300 WAS MAINTAINED. VISITAG MODULE WAS USED WITH RESPIRATION GATING, 3MM/3SEC STABILITY AND TIME AS COLORING OPTION. STEAM POP IS NOT CONSIDERED TO BE A DEVICE MALFUNCTION SINCE STEAM POP IS AN EXPECTED PHYSIOLOGICAL PHENOMENON. ADDITIONAL FOLLOW UP IS BEING DONE TO OBTAIN CLARIFICATION REGARDI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9144424 ↗
• InjuryOct 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A NAVISTAR¿ DS ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, THE PATIENT¿S BLOOD PRESSURE DROPPED. CARDIAC TAMPONADE WAS CONFIRMED BY TRANSTHORACIC ECHO (TEE). PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 450 CC¿S OF FLUID FROM THE PERICARDIUM. PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER THE PERICARDIAL DRAINAGE. THE PATIENT REQUIRED AN OVERNIGHT STAY IN THE INTENSIVE CARE UNIT (ICU) FOR MONITORING PURPOSES. PATIENT¿S OUTCOME IS UNKNOWN. THERE¿S NO INFORMATION REGARDING PHYSICIAN CAUSALITY OPINION. HOWEVER, HE DID NOT ATTRIBUTE THE CAUSE OF THE ADVERSE EVENT TO A BIOSENSE WEBSTER INC. (BWI) PRODUCT. THERE WERE NO ERROR MESSAGES REPORTED ON ANY BWI EQUIPMENT DURING THE PROCEDURE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GAIN CLARIFICATION ON THIS EVENT WITH NO RESPONSE. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Cardiac Tamponade

  MAUDE report 8007083 ↗
• InjuryOct 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR RIGHT SIDED ATRIAL FLUTTER WITH A NAVISTAR¿ DS ELECTROPHYSIOLOGY CATHETER AND SUFFERED ATRIOVENTRICULAR HEART BLOCK REQUIRING PERMANENT PACEMAKER IMPLANTATION. DURING THE PROCEDURE, A COMPLETE HEART BLOCK WAS NOTICED AND WAS CONFIRMED BY CARTO 3 AND ELECTROPHYSIOLOGY RECORDING SYSTEMS. A PERMANENT PACEMAKER WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER THE PROCEDURE. EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME IS UNCHANGED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE AND PATIENT CONDITION RELATED.

  Patient problems: Arrhythmia; No Code Available

  MAUDE report 7936439 ↗