EZ Steer BD7TCDF4LRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10846835002515), received between Jun 29, 2016 and Nov 5, 2025 — classified as 7 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN EZ STEER CATHETER AND THE TIP APPEARED DAMAGED WHICH EXPOSED INTERNAL COMPONENTS. IT WAS REPORTED THAT THERE WAS 60 HZ NOISE DISPLAYED ON THE DISTAL ABLATION CATHETER SIGNAL, DISPLAYED ON THE ABBOTT EP RECORDING SYSTEM. THIS WAS A NON-NAVIGATIONAL A-V NODE ABLATION WITH THE NGEN¿ RF GENERATOR. THEY REMOVED THE CATHETER FROM THE PATIENT AND NOTICED THE TIP APPEARED TO BE DAMAGED, EXPOSING INTERNAL COMPONENTS. THEY OPENED A REPLACEMENT CATHETER (DIFFERENT LOT) AND THE SECOND CATHETER HAD THE SAME ISSUE WITH DAMAGED TIP, NOTICED PRIOR TO PATIENT INSERTION. THEY OPENED A THIRD CATHETER (NORMAL TIP), BUT THE NOISE WAS STILL PRESENT ON THE RECORDING SYSTEM. THEY REPLACED THE CABLE FROM CATHETER TO GENERATOR (BOTH WERE NEW, NON-REPROCESSED), WITHOUT RESOLUTION. THEY REPLACED THE ABBOT PIN BLOCK THAT THE PIN CABLE FROM GENERATOR WAS CONNECTED TO, WITHOUT RESOLUTION. THE ISSUE REMAINED UNRESOLVED. THE ISSUE WAS FOUND NEAR THE PROXIMAL ELECTRODES. THERE WAS NO OTHER PHYSICAL DAMAGE. THERE WAS NO DIFFICULTY EXPERIENCE WHILE MANEUVERING THE CATHETER OR DURING WITHDRAWAL. THE ISSUE OF TIP DAMAGE WITH INTERNAL COMPONEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23483383 ↗
• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN EZ STEER CATHETER AND THE TIP APPEARED DAMAGED WHICH EXPOSED INTERNAL COMPONENTS. IT WAS REPORTED THAT THERE WAS 60 HZ NOISE DISPLAYED ON THE DISTAL ABLATION CATHETER SIGNAL, DISPLAYED ON THE ABBOTT EP RECORDING SYSTEM. THIS WAS A NON-NAVIGATIONAL A-V NODE ABLATION WITH THE NGEN¿ RF GENERATOR. THEY REMOVED THE CATHETER FROM THE PATIENT AND NOTICED THE TIP APPEARED TO BE DAMAGED, EXPOSING INTERNAL COMPONENTS. THEY OPENED A REPLACEMENT CATHETER (DIFFERENT LOT) AND THE SECOND CATHETER HAD THE SAME ISSUE WITH DAMAGED TIP, NOTICED PRIOR TO PATIENT INSERTION. THEY OPENED A THIRD CATHETER (NORMAL TIP), BUT THE NOISE WAS STILL PRESENT ON THE RECORDING SYSTEM. THEY REPLACED THE CABLE FROM CATHETER TO GENERATOR (BOTH WERE NEW, NON-REPROCESSED), WITHOUT RESOLUTION. THEY REPLACED THE ABBOT PIN BLOCK THAT THE PIN CABLE FROM GENERATOR WAS CONNECTED TO, WITHOUT RESOLUTION. THE ISSUE REMAINED UNRESOLVED. THE ISSUE WAS FOUND NEAR THE PROXIMAL ELECTRODES. THERE WAS NO OTHER PHYSICAL DAMAGE. THERE WAS NO DIFFICULTY EXPERIENCE WHILE MANEUVERING THE CATHETER OR DURING WITHDRAWAL. THE ISSUE OF TIP DAMAGE WITH INTERNAL COMPONEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23483373 ↗
• MalfunctionDec 3, 2024Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid; High Readings; Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid; High Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN EZ STEER AND EXCESSIVE CARBONIZATION OCCURRED. THE DOCTOR NOTICED THE IMPEDANCE RISING ABRUPTLY AND TOOK OFF THE CATHETER TO CHECK THE TIP. IN THIS WAY, HE NOTICED A LOT OF CARBONIZATION OF THE DISTAL ELECTRODE. HE ALSO REPORTED A DIFFICULTY IN CLEANING THE ELECTRODE SO THAT IT WOULD BE FREE OF ANY REMAINING OF MATERIAL. THE CUSTOMER¿S INITIAL REPORT OF CARBONIZATION/CHAR WAS NOT CONSIDERED TO BE MDR REPORTABLE. CHAR IS A PHYSICAL PHENOMENON OF RADIOFREQUENCY ABLATION AND CAN BE A NORMAL RESULT OF THE ABLATION PROCESS. THE PRESENCE OF CHAR DOES NOT BY ITSELF REPRESENT A SERIOUS INJURY, NOR IS IT NECESSARILY THE RESULT OF A DEVICE MALFUNCTION. ON 19-NOV-2024, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE SYSTEM DID NOT PRESENT ANY ERROR MESSAGES. THERE WAS NO PROBLEMS WITH TEMPERATURE OR FLOW. THE PATIENT WAS ANTICOAGULATED. ADDITIONALLY, THE PHYSICIAN CONSIDERED THE CHARRING TO BE EXCESSIVE. BASED ON THE PHYSICIAN¿S OPINION, THE EVENT WAS REASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20839361 ↗
• MalfunctionDec 2, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH AN EZ STEER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A BROKEN TIP WITH INTERNAL COMPONENTS EXPOSED. IT WAS INITIALLY REPORTED BY THE PHYSICIAN THAT DURING A STANDARD SVT PROCEDURE HE WAS USING A 4MM NON-NAV CATHETER AND UPON INSERTING IT INTO THE PATIENT HE NOTICED THAT THE TIP WAS KINKED ON FLUOROSCOPY. HE REMOVED THE CATHETER TO INSPECT THE TIP AND VERIFIED THAT IT WAS KINKED. HE DOES NOT RECALL USING EXCESSIVE FORCE UPON INSERTING THE CATHETER OR DURING MANIPULATION. THE CATHETER WAS REPLACED BY THE HOSPITAL STAFF. THERE WAS NO PATIENT INJURY. THERE WERE NO EXPOSED WIRES, SHARP OR LIFTED ELECTRODE RINGS AND THE PHYSICIAN DID NOT FEEL ANY RESISTANCE DURING INSERTION/REMOVAL OF THE CATHETER. THE CATHETER WAS NO PRE-SHAPED AND THERE WERE NO FRAGMENTS GENERATED FROM THE REPORTED KINK. THE CUSTOMER'S REPORTED BENT/KINKED TIP IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON 6-NOV-2024, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20820398 ↗
• InjuryOct 23, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT)/ ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA (AVNRT) ABLATION WITH A EZ STEER¿ BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED HEART BLOCK THAT REQUIRED PACEMAKER INSERTION. THE CASE WAS LISTED AS AN SVT CASE, AFTER THE EP (ELECTROPHYSIOLOGY) STUDY THE MEDICAL TEAM FOUND THAT IT WAS AN AVNRT CASE SO AT THIS POINT THE PHYSICIAN DECIDED HE DIDN¿T WANT TO USE CARTO TO MAP AND JUST TOOK A NON-NAV CATHETER AND USED X-RAY. THE PHYSICIAN USED A NON-NAV EZ STEER NON-IRRIGATED CATHETER. THE MEDICAL TEAM CARRIED OUT 5 ABLATIONS AT 40 W SUCCESSFULLY. ON THE 6TH ABLATION THE PHYSIOLOGIST SAW V'S WITH NO A'S SO THE DOCTOR STOPPED ABLATING. THE ABLATION ONLY LASTED 6S WITH A NORMAL TEMPERATURE RISE AND IMPEDANCE CHANGE. THE PATIENT THEN EXPERIENCED AV (ATRIOVENTRICULAR) DISSOCIATION. AT THIS POINT, THE TEAM WAITED AN HOUR WHILST PACING AND THE PATIENT THEN HAD 2:1 CONDUCTION WHEN LEAVING THE LAB., THE DOCTOR SUGGESTED AN OVERNIGHT STAY FOR THE PATIENT TO MONITOR HIM AND HOPE FOR A FULL RECOVERY. INTERVENTION INCLUDED CS (CORONARY SINUS) PACING AND EXTENDED HOSPITALIZATION (OVERNIGHT MONITORING). TH

  Patient problems: Heart Block

  MAUDE report 20517054 ↗
• MalfunctionMay 6, 2024Manufacturing, Packaging or Shipping Problem; Material Protrusion/Extrusion; Material Twisted/Bent; Manufacturing, Packaging or Shipping Problem; Material Protrusion/Extrusion; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH AN EZ STEER¿ BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND AN ELECTRODE LIFTED OR TWISTED ISSUE OCCURRED. THE CUSTOMER REPORTED NOTICING THAT ABLATION CATHETER TIP WAS BENT WHEN THEY TOOK IT OUT OF THE PACKAGE. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON 09-APR-2024. THE DAMAGE DID RESULT IN LIFTED OR SHARP RINGS, AS ELECTRODE NUMBER 1 SEEMED TO BE ¿LIFTED¿ OR TWISTED. THE CATHETER WAS NOT USED IN PATIENT. THE ISSUE WAS FOUND AT THE VERY DISTAL TIP, BETWEEN ELECTRODES 1 AND 2. THE CATHETER WAS NOT PRE-SHAPED. THE CATHETER WAS NOT INSERTED IN ANY SHEATH. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF THE ELECTRODE LIFTED OR TWISTED ON 09-APR-2024 AND HAVE REASSESSED THE EVENT AS REPORTABLE. THE AWARENESS DATE FOR THIS RECORD IS 09-APR-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19255843 ↗
• InjuryMar 7, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A CLINICAL TRIAL, IT WAS REPORTED THAT A PATIENT UNDERWENT A REPEAT ATRIAL FIBRILLATION ABLATION PROCEDURE WITH AN EZ STEER¿ BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER ON (B)(6) 2023 AND SUFFERED DYSPNEA. ON (B)(6) 2023, PATIENT EXPERIENCED DYSPNEA CATEGORIZED AS SEVERE AND SERIOUS, CATEGORIZED BY SERIOUS DETERIORATION IN THE HEALTH OF THE SUBJECT AS DEFINED BY IN-PATIENT / PROLONGED HOSPITALIZATION (ADMISSION DATE: (B)(6) 2023 AND DISCHARGE DATE (B)(6) 2023) AND MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY, OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION. RELATIONSHIP TO STUDY DEVICE IS NOT RELATED. THE ADVERSE EVENT IS EXPECTED/ANTICIPATED. THE OUTCOME IS RECOVERED/RESOLVED. INTERVENTION WAS MEDICATION AND PACEMAKER RE-PROGRAMMING. DEVICE DISPOSITION WAS INSERTED AND RADIO FREQUENCY WAS DELIVERED. ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2024. RELATIONSHIP TO REPEAT STUDY PROCEDURE IS POSSIBLE. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE THAT THE RELATIONSHIP TO THE REPEAT STUDY PROCEDURE IS POSSIBLE ON (B)(6) 2024 AND HAVE REASSESSED THE EVENT AS REPORTABLE.

  Patient problems: Dyspnea

  MAUDE report 18857548 ↗
• MalfunctionJun 28, 2023Break; High Readings; Break; High Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN EZ STEER¿ BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND A RUPTURE IN THE CATHETER COATING. THE CATHETER CAUSED AN INCREASE IN IMPEDANCE IN RADIOFREQUENCY (RF). WHEN REMOVING THE CATHETER, IT WAS OBSERVED THAT THERE WAS A RUPTURE IN THE CATHETER COATING. AFTER THE EXCHANGE, IT WORKED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17222524 ↗
• InjuryJan 25, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH AN EZ STEER¿ BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. IT WAS REPORTED THAT AVNRT WAS ASSESSED VIA EP STUDY. PATIENT UNDERWENT TAMPONADE PRIOR TO AVNRT ABLATION. ADDITIONAL INFORMATION WAS RECEIVED. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. PERICARDIOCENTESIS WAS PERFORMED. IT WAS UNKNOWN IF THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. GENERATOR INFORMATION WAS A NGEN, SN UNKNOWN. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. PRIOR TO NOTING THE CARDIAC TAMPONADE, ABLATION WAS NOT PERFORMED. THERE IS NO EVIDENCE OF STEAM POP. THE EVENT OCCURRED DURING THE EP STUDY PHASE. NO IRRIGATED CATHETER WAS USED.

  Patient problems: Cardiac Tamponade

  MAUDE report 16243965 ↗
• MalfunctionNov 4, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN AVNRT ABLATION PROCEDURE WITH A EZ STEER¿ BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER. IT WAS REPORTED BY THE BWI REPRESENTATIVE THAT WHEN THE CATHETER WAS REMOVED FROM THE BOX, ONE OF THE SIDES OF THE STERILE PACKAGING SEAL WAS OPEN. THE CATHETER WAS REPLACED, AND THE ISSUE WAS RESOLVED. NO PATIENT CONSEQUENCES WERE REPORTED. OPEN POUCH SEAL IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15730514 ↗
• InjurySep 22, 2021Signal Artifact/Noise; Patient Device Interaction Problem; Signal Artifact/Noise; Patient Device Interaction Problem

  INITIALLY, IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED AN ATRIOVENTRICULAR (AV) HEART BLOCK REQUIRING A TEMPORARY PACEMAKER. ON (B)(6) 2021, ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS REPORTED THAT AN EZ STEER¿ BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER WAS ALSO RELATED TO THE ADVERSE EVENT THAT WAS REPORTED. SINCE THE ELECTRICAL POTENTIALS OF THE ABLATION CATHETER WERE NOISY, THE CABLES WERE RE-CONNECTED AND EXCHANGED, BUT THEY WERE NOT RESOLVED. BECAUSE IT WAS AVNRT (ATRIOVENTRICULAR (AV) NODAL REENTRANT TACHYCARDIA), IT WAS GIVING OUT CELSIUS, BUT BECAUSE ATRIAL TACHYCARDIA (AT) STARTED TO RUN DURING THE TROUBLE OF ABLATION CATHETER, THE CATHETER WAS CHANGED TO STSF. AFTER THAT, THERE WAS NO PROBLEM WITH THE PRODUCT ITSELF. HOWEVER, AFTER ATRIAL TACHYCARDIA (AT) WAS STOPPED DUE TO ABLATION, AVNRT STARTED RUNNING AGAIN. DURING ABLATION, AV BLOCK WAS GENERATED, AND A TEMPORARY PULSE WAS INSERTED. THE ISSUE WAS RESOLVED BY CHANGING THE CATHETER TO ANOTHER ONE. THE PATIENT HAD AV BLOCK, ¿NRT ITSELF WAS HARDLY INDUCED WITHOUT LOADING ISP¿. A

  Patient problems: Heart Block

  MAUDE report 12516164 ↗
• InjuryApr 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ACCESSORY PATHWAY ABLATION PROCEDURE WITH AN EZ STEER¿ BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND THERMOCOOL® SF BI-DIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE. DURING THE ACCESSORY PATHWAY PROCEDURE, A CARDIAC TAMPONADE WAS DETECTED. THERE IS NO INFORMATION REGARDING INTERVENTIONS, EXTENDED HOSPITALIZATION, PATIENT OUTCOME, FACTORS THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT, OR THE PHYSICIAN¿S CAUSALITY OPINION. THERE WERE NO ERRORS REPORTED ON ANY BIOSENSE WEBSTER, INC. PRODUCTS OR EQUIPMENT DURING THE PROCEDURE. THERE IS NO INFORMATION REGARDING TRANSSEPTAL PUNCTURE, SHEATH, GENERATOR PARAMETERS, GENERATOR SETTINGS, POWER TITRATION, OVERALL ABLATION TIME AT THE SITE OF INJURY, LAST ABLATION CYCLE TIME AT THE SITE OF INJURY, IRRIGATED CATHETER FLOW RATE, OR ANTICOAGULATION DURING THE PROCEDURE. THIS WAS NOT A CARTO SYSTEM CASE, AS THE CATHETERS WERE NON-NAVIGATIONAL.

  Patient problems: Cardiac Tamponade

  MAUDE report 7442316 ↗
• InjuryMar 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR SUPRAVENTRICULAR TACHYCARDIA (SVT) WITH AN EZ STEER¿ BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED A HEART BLOCK REQUIRING SURGICAL INTERVENTION. ELECTROPHYSIOLOGY TESTING REVEALED ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT). MAPPING WAS PERFORMED WITH FAST ANATOMICAL MAP (FAM) GEOMETRY AND BIPOLAR ELECTRICAL MAPPING ON THE ENDOCARDIAL AREAS OF INTEREST. HIS BUNDLE WAS LOCATED AND DENOTED WITH MARKERS ON THE ENDOCARDIAL MAP. DURING THE FINAL ABLATION, THREE BEATS OF ATRIOVENTRICULAR (AV) DISSOCIATION WERE OBSERVED ON ELECTROGRAMS AND CONFIRMED VIA ECHOCARDIOGRAM (ECG). ABLATION WAS STOPPED IMMEDIATELY. HEART BLOCK 2ND DEGREE TYPE II DISPLAYED ON THE MONITOR. INTRAVENOUS SOLUMEDROL WAS ADMINISTERED AND PATIENT WAS OBSERVED FOR 40 MINUTES, DURING WHICH TIME THE HEART BLOCK CONVERTED FROM 2ND DEGREE TYPE II TO 2ND DEGREE TYPE I. A TEMPORARY PACEMAKER WAS INSERTED. PATIENT WAS ADMITTED TO THE FACILITY FOR OVERNIGHT OBSERVATION. AT AN UNSPECIFIED POINT POST-PROCEDURE, A PERMANENT PACEMAKER WAS IMPLANTED. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. THERE IS N

  Patient problems: Arrhythmia; No Code Available

  MAUDE report 7336699 ↗
• InjuryMar 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR SUPRAVENTRICULAR TACHYCARDIA (SVT) WITH AN EZ STEER¿ BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED A HEART BLOCK REQUIRING SURGICAL INTERVENTION. DURING ABLATION AROUND THE SLOW PATHWAY, THE PATIENT WENT INTO HEART BLOCK. A DUAL-CHAMBER PACEMAKER WAS IMPLANTED. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT FOR RECOVERY FROM PACEMAKER IMPLANTATION. PATIENT OUTCOME REMAINS UNCHANGED. IT WAS NOTED THAT THE PATIENT ARRIVED AT THE PROCEDURE ROOM IN NORMAL SINUS RHYTHM. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. THERE WERE NO ISSUES OR ERRORS REPORTED WITH ANY BWI PRODUCTS OR EQUIPMENT DURING THE PROCEDURE. THERE WERE NO ISSUES OR ERRORS REPORTED WITH ANY BWI PRODUCTS OR EQUIPMENT DURING THE PROCEDURE.

  Patient problems: Arrhythmia; Not Applicable

  MAUDE report 7336681 ↗
• MalfunctionJun 29, 2016Delivered as Unsterile Product; Unsealed Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH AN EZ STEER NON-NAV 4MM CATHETER FOR WHICH THE PACKAGING WAS DISCOVERED TO BE OPEN AT THE TOP. DURING THE PROCEDURE, IT WAS FOUND THAT THE POUCH SEAL WAS COMPROMISED, THOUGH THE BOX HAD NEVER BEEN OPENED. THE CATHETER FROM THE BOX WITH THE OPEN POUCH SEAL WAS NOTED TO HAVE COMPROMISED STERILITY AS A RESULT. IT WAS NEVER PLACED INTO THE STERILE FIELD, NOR DID IT COME INTO CONTACT WITH THE PATIENT. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE, WHICH COMPLETED WITHOUT ANY PATIENT CONSEQUENCES. PACKAGING DEFECTS COMPROMISE THE STERILITY OF THE PRODUCT, POTENTIALLY EXPOSING THE PATIENT TO THE INTRODUCTION OF MICROORGANISMS INTO THE VASCULATURE. POSSIBLE CONSEQUENCES OF THIS EXPOSURE ARE INFECTION AND SEPSIS, WHICH MAY RESULT IN THE PATIENT NEEDING TO RECEIVE ADDITIONAL MEDICAL INTERVENTION TO PRECLUDE PERMANENT INJURY OR IMPAIRMENT. AS A RESULT, THIS ISSUE IS MDR REPORTABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5758842 ↗