NaviStar DS NS7TCD8L174HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10846835000580), received between May 10, 2017 and Aug 1, 2019 — classified as 6 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 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.

• InjuryAug 1, 2019Adverse 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 WEBSTER¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED HEART BLOCK AV 3RD DEGREE REQUIRING PACEMAKER IMPLANTATION. DURING THE PROCEDURE JUST BEFORE THE TRANSSEPTAL PUNCTURE, HEART BLOCK AV 3RD DEGREE WAS DISCOVERED AND CONFIRMED WITH ELECTROCARDIOGRAM ECG. A TEMPORARY PACEMAKER WAS IMPLANTED. THE PATIENT WAS REPORTED IN STABLE CONDITION AFTER PACEMAKER IMPLANTATION. THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT ICU AND REQUIRED AN ADDITIONAL DAY OF HOSPITALIZATION FOR OBSERVATION PURPOSES. PATIENT¿S OUTCOME WAS FULLY RECOVERED WITH NO RESIDUAL EFFECTS AND WAS DISCHARGED TO HOME. THE EVENT HAPPENED BEFORE THE ABLATION. THERE WAS NO ABLATION CATHETER IN THE PATIENT AT THE TIME OF THE EVENT. PHYSICIAN INSERTED A TEMPORARY PACING WIRE AND PACED THE PATIENT USING THE RIGHT VENTRICLE (RV) CATHETER AND PROCEEDED WITH THE CASE, WHICH INCLUDED LEFT ATRIAL ABLATION. NO ABLATING WAS DONE NEAR THE CONDUCTION SYSTEM. THE CATHETERS THAT WERE INSIDE THE PATIENT¿S BODY AT THE TIME OF THE EVENT WERE THE RV (QUADRAPOLAR), CORONARY SINUS CS (DECAPOLAR), AND HIS BUNDLE (OCTAPOLAR) CATHETERS. PHYSIC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8853061 ↗
• InjuryJul 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL TACHYCARDIA (AT) ABLATION PROCEDURE WITH A NAVISTAR¿ DS ELECTROPHYSIOLOGY CATHETER AND SUFFERED ACUTE MYOCARDIAL INFRACTION REQUIRING CARDIAC MASSAGE. IMMEDIATELY AFTER ABLATION FOR AT NEAR THE HIS BUNDLE FROM THE AORTA, THE PATIENT¿S HEMODYNAMICS WAS COMPROMISED. CARDIAC MASSAGE WAS PERFORMED, AND THE PATIENT RECOVERED. THE PROCEDURE WAS COMPLETED. THERE¿S NO INFORMATION REGARDING EXTENDED HOSPITALIZATION. PATIENT¿S OUTCOME AND PHYSICIAN CAUSALITY OPINION ARE UNKNOWN. NO BWI PRODUCT MALFUNCTIONS WERE REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GAIN CLARIFICATION ON THIS EVENT WITH NO RESPONSE. SHOULD ANY NEW INFORMATION BE OBTAINED IT WILL BE ASSESSED AND PROCESSED ACCORDINGLY.

  Patient problems: Myocardial Infarction

  MAUDE report 8773520 ↗
• InjuryJun 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT ((B)(6)) UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A NAVISTAR¿ DS ELECTROPHYSIOLOGY CATHETER AND A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. AFTER THE CASE WAS OVER, AND THEY WERE PREPARING TO PULL THE SHEATHS THE PATIENT¿S BLOOD PRESSURE DROPPED, AND CARDIAC TAMPONADE WAS CONFIRMED BY TRANSTHORACIC ECHO (TEE). PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 250CC OF FLUID FROM THE PERICARDIAL SPACE. THE PATIENT WAS REPORTED IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE. THE PATIENT STAYED AN EXTRA DAY FOR OBSERVATION PURPOSES. PATIENT¿S OUTCOME IS IMPROVED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED, PHYSICIAN BELIEVES THE ISSUE WAS CAUSED BY WEBSTER RV CATHETER MANIPULATION NEAR THE END OF THE PROCEDURE, (AFTER THE ABLATION PART OF THE PROCEDURE WAS OVER) DUE TO NON-CAPTURE AND FELT THAT THE REPOSITIONING OF THE RV CATHETER RESULTED IN THE INJURY. HE MENTIONED THAT HE THINKS THIS CATHETER IS STIFFER THAN SOME OTHERS, AND THAT THE PATIENT¿S ANATOMY (THINNER VENTRICLE) MIGHT HAVE ALSO CONTRIBUTED TO THE ADVERSE EVEN

  Patient problems: Cardiac Tamponade

  MAUDE report 8746944 ↗
• InjuryMar 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT IN THEIR MID-EIGHTIES UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A NAVISTAR¿ DS ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, THERE WAS A DROP-IN PATIENT¿S BLOOD PRESSURE. CARDIAC TAMPONADE WAS CONFIRMED BY ECHO. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 250 CC OF FLUID FROM THE PERICARDIUM. BLOOD TRANSFUSION WAS ALSO PERFORMED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE. THE PATIENT STAYED OVERNIGHT IN THE INTENSIVE CARE UNIT (ICU). PATIENT¿S OUTCOME IS FULLY RECOVERED. PATIENT¿S ANATOMY WAS CITED AS A FACTOR THAT MIGHT HAVE CONTRIBUTED TO THE ADVERSE EVENT (LARGE PATIENT). PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED, THE PHYSICIAN ASSUMED THE EVENT OCCURRED DURING THE ABLATION. NO ERROR MESSAGES WERE OBSERVED ON ANY BIOSENSE WEBSTER, INC. EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL SL-2 TRANSSEPTAL SHEATH AND A BRK TRANSSEPTAL NEEDLE. A ST. JUDE MEDICAL SL-2 8FR SHEATH WAS USED DURING THE CASE. THE GENERATOR WAS BEING USED IN TE

  Patient problems: Cardiac Tamponade

  MAUDE report 8463027 ↗
• InjuryJul 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A NAVISTAR¿ DS ELECTROPHYSIOLOGY CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING ABLATION PHASE, THE PATIENT BECAME HYPOTENSIVE. TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) REVEALED A PERICARDIAL EFFUSION. PERICARDIOCENTESIS YIELDED 400 ML. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PATIENT REQUIRED EXTENDED HOSPITALIZATION (ONE NIGHT) IN THE INTENSIVE CARE UNIT (ICU) FOR DRAINAGE MONITORING. PATIENT FULLY RECOVERED. IT WAS NOTED THAT THE ADVERSE EVENT WAS DISCOVERED POST-ABLATION OF THE SUSPECTED SITE OF INJURY. PATIENT FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT INCLUDE A VERY SMALL BODY HABITUS AND A SMALL HEART. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. THERE WERE NO ISSUES, ERRORS, OR MALFUNCTIONS REPORTED ON ANY BIOSENSE WEBSTER INC. PRODUCTS OR EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK-1 TRANSSEPTAL NEEDLE AND A ST. JUDE MEDICAL 8 FRENCH SL2 SHEATH. GENERATOR WAS SET ON TEMPERATURE CONTROL MODE. GENERATOR PARAMETERS INCL

  Patient problems: Cardiac Tamponade

  MAUDE report 7684532 ↗
• InjuryMay 10, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A NAVISTAR DS CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS WITH PERICARDIAL DRAIN. DURING ABLATION PHASE, AFTER SOME ABLATION WAS PERFORMED, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS DETECTED. PERICARDIOCENTESIS YIELDED AN UNSPECIFIED AMOUNT OF FLUID. REMAINDER OF PROCEDURE WAS ABORTED. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PERICARDIAL DRAIN WAS LEFT IN PLACE OVERNIGHT. PATIENT REQUIRED EXTENDED HOSPITALIZATION (1 ADDITIONAL DAY) AS A RESULT OF THE ADVERSE EVENT. PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT INCLUDE THE PATIENT¿S SMALL BODY HABITUS. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK 71 CM TRANSSEPTAL NEEDLE. SHEATH USED WAS A ST. JUDE MEDICAL SL2 8 FRENCH. GENERATOR PARAMETERS INCLUDED TEMPERATURE CONTROL MODE AT 55 DEGREES CELSIUS, POWER AT 50 WATTS, AND 40 SECONDS. AVERAGE TEMPERATURE WAS 53.2 DEGREES CELSIUS AND IMPEDANCE WAS 99 OHMS. POWER WAS

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 6557102 ↗