PENTARAY NAV D128210Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10846835012248), received between Jan 29, 2018 and Mar 10, 2026 — classified as 5 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (8 reports).

2 FDA recall records name this device's identifier.

3 other recalls cover devices cleared under the same FDA submission (K123837); they may or may not involve this specific model.

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.

Recalls naming this device

1. Apr 22, 2020Terminated

   Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.

   Z-2372-2020 · Root cause: Error in labeling · FDA record ↗

2. May 17, 2017Terminated

   Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.

   Z-0212-2018 · Root cause: Other · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A PENTARAY NAV CATHETER AND OBSERVED AN OCCLUSION/ NO IRRIGATION (DEVICE USED ON THE PATIENT) ISSUE. OCCLUSION/ NO IRRIGATION. DURING THE PROCEDURE, DEVICE (INCLUDING PORT, LUER HUB) WAS NOT IRRIGATING. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 11-FEB-2026. THE SUSPECTED DEVICE FOR THE REPORTED FLOW/IRRIGATION ISSUE WAS THE CATHETER. THE ISSUE WAS NOT NOTED BEFORE THE DEVICE WAS USED ON THE PATIENT. THE SMARTABLATE PUMP WAS USED. NO ERROR NOTED FROM THE IRRIGATION PUMP. STEPS TAKEN TO RESOLVE THE IRRIGATION ISSUE WAS TO ATTEMPT TO FORCEFULLY DRAIN THE FLUID USING A SYRINGE. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. NO ISSUES WITH FLOW RATE CHANGE AT THE START OF THE ABLATION. THE OCCLUSION/ NO IRRIGATION ISSUE WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE ON 11-FEB-2026 THAT THE DEVICE WAS USED ON THE PATIENT AND HAVE REASSESSED THE ISSUE AS REPORTABLE. THE AWARENESS DATE FOR THIS RECORD IS 11-FEB-2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558596 ↗
• MalfunctionMar 4, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A PENTARAY NAV AND AN IRRIGATION ISSUE (DEVICE USED IN PATIENT) WAS OBSERVED. IRRIGATION INADEQUATE. DURING THE PROCEDURE, THERE WAS AN INTERMITTENT OR LOW IRRIGATION ON THE DEVICE BUT NOT COMPLETE OCCLUSION. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 09-FEB-2026. THE SUSPECTED DEVICE FOR THE REPORTED FLOW/IRRIGATION ISSUE WAS THE CATHETER. THE DEVICE WAS USED IN THE PATIENT. THE SMARTABLATE SYSTEM-PUMP CHINA/ 4900403 WAS USED. NO ERROR WAS NOTED FROM THE IRRIGATION PUMP. THE ISSUE WAS DISCOVERED BY POOR PERFUSION. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. NO ISSUES WITH FLOW RATE CHANGE AT THE START OF THE ABLATION. THE IRRIGATION ISSUE ORIGINALLY REPORTED IS NON REPORTABLE; HOWEVER, BWI BECAME AWARE ON 09-FEB-2026 THAT THE DEVICE WAS USED IN THE PATIENT AND HAVE REASSESSED THE IRRIGATION ISSUE (DEVICE USED IN PATIENT) AS REPORTABLE. THE AWARENESS DATE FOR THIS RECORD IS 09-FEB-2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507009 ↗
• MalfunctionDec 29, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PAROXYSMAL ABLATION PROCEDURE WITH A PENTARAY NAV CATHETER AND THE DEVICE (INCLUDING PORT, LUER HUB) WAS NOT IRRIGATING. A PRESSURIZED SALINE BAG WAS USED TO RESOLVE THE ISSUE; HOWEVER, IT DID NOT PRODUCE WATER. THE SMARTABLATE WAS THEN USED FOR RINSING--TO NO AVAIL. THE CATHETER HAD BEEN USED INSIDE OF THE PATIENT. THERE WERE NO FLOW RATE CHANGES OR ISSUES AT THE START OF THE PROCEDURE. THE CORRECT CATHETER SETTINGS HAD BEEN SELECTED ON THE GENERATOR. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23916466 ↗
• MalfunctionAug 28, 2025Material Separation; Device-Device Incompatibility; Material Separation; Device-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ¿ PAROXYSMAL ABLATION PROCEDURE WITH A PENTARAY NAV AND THE DEVICE WAS FOUND DAMAGED. IT WAS REPORTED THAT BEFORE THE OPERATION, THE PENTARAY NAV COULD NOT ADVANCE IN THE OUTER SHEATH DUE TO AN IMPEDIMENT. WHILE WITHDRAWING THE DEVICE OUT, DAMAGE WAS FOUND. DEVICE WAS NOT USED ON THE PATIENT. A SECOND DEVICE WAS USED WITH THE SAME SHEATH TO COMPLETE THE OPERATION. THERE WAS NO PATIENT ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910590 ↗
• MalfunctionAug 22, 2025Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED THAT THE DEVICE TIP WAS FULLY SEPARATED. DURING THE PROCEDURE, THE MAGNETIC SENSOR ISSUE/ERROR WAS DISPLAYED. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874539 ↗
• MalfunctionAug 3, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PAROXYSMAL ABLATION PROCEDURE WITH A PENTARAY NAV. INITIALLY, IT WAS INDICATED THAT DURING THE OPERATION, THE TIP OF THE DEVICE WAS FOUND TO HAVE BEEN DAMAGED. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. WITH THE INITIAL INFORMATION AVAILABLE, THIS EVENT WAS ASSESSED AS NON MDR REPORTABLE. HOWEVER, ON 12-JUL-2025, ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE DAMAGE RESULTED IN WIRES BEING EXPOSED. THEREFORE, THE EVENT WAS RE-ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 12-JUL-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22696546 ↗
• MalfunctionJul 29, 2025Signal Artifact/Noise; Material Twisted/Bent; Signal Artifact/Noise; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A SPLINE DETACHMENT. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT DURING THE OPERATION, THE SIGNAL INTERFERENCE (NOISE) WAS OBSERVED ON INTRACARDIAC (IC) CHANNELS WHILE THE CATHETER WAS IN THE PATIENT¿S BODY. SEVERE INTERFERENCE WAS OBSERVED ON THE 13 & 14 ELECTRODES. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. THE NOISE WAS OBSERVED ONLY ON THE CARTO 3 SYSTEM AND THE PHYSICIAN DID HAVE OTHER INTACT ECG SIGNAL AVAILABLE TO MONITOR PATIENT HEART RHYTHM. THE CUSTOMER'S REPORTED NOISE ISSUE 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 28-JUL-2025, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A SPLINE WAS DETACHED, LEAVING INTERNAL COMPONENTS EXPOSED. THESE FINDINGS WERE REVIEWED AND ASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22645673 ↗
• MalfunctionJul 15, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV AND IT WAS NOT IRRIGATING. DURING THE OPERATION, THE DEVICE WAS NOT IRRIGATING. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THE CUSTOMER'S REPORTED OCCLUSION ISSUE 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 26-JUN-2025, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE DEVICE SUSPECTED OF THE ISSUE IS THE CATHETER. THERE WAS NO ERROR NOTED FROM THE IRRIGATION PUMP, IT WAS THE CATHETER THAT DOES NOT RELEASE WATER. THEY FLUSHED WITH THE SYRINGE, BUT IT DID NOT FLUSH. THE CORRECT CATHETER SETTINGS WERE SET ON THE GENERATOR AND THERE WERE NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION. THE ISSUE WAS NOT NOTICED BEFORE BEING USED ON THE PATIENT, AS SUCH, THE EVENT WAS REASSESSED AS AN MDR REPORTABLE MALFUNCTION SINCE THE IRRIGATION ISSUE WAS NOTICE WHILE IT WAS IS USE ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22515699 ↗
• MalfunctionJul 9, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PAROXYSMAL ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED THAT THE TIP WAS BROKEN AND THERE WERE STRESS MARKS IN THE BROKEN AREA. DURING THE PROCEDURE, THE CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22462332 ↗
• MalfunctionMay 2, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV AND DURING THE PROCEDURE, THERE WAS AN INTERMITTENT OR LOW IRRIGATION ON THE DEVICE BUT NOT COMPLETE OCCLUSION. THERE WAS NO ERROR NOTED FROM THE IRRIGATION PUMP. THE TIP OF THE DEVICE WAS NOT IRRIGATING. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21952828 ↗
• MalfunctionOct 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND THE MEDICAL TEAM NOTED THAT THE DEVICE'S SPLINE HAD COME LOOSE IN THE SL0 SHEATH. THEY WERE ABLE TO PULL IT OUT SLOWLY. X-RAYS SHOWED THAT SOMETHING WAS STILL ATTACHED TO THE TIP OF THE SL0, WHICH THEY SUSPECTED WAS A PIECE OF THE PENTARAY OR AN ELECTRODE. THEY DID NOT NOTE ANY DAMAGE OR LIFTED RINGS. NO FURTHER DETAILS WERE PROVIDED REGARDING THE REST OF THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20538746 ↗
• MalfunctionSep 15, 2024Manufacturing, Packaging or Shipping Problem; Material Twisted/Bent; Manufacturing, Packaging or Shipping Problem; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A PENTARAY NAV FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED AN ELECTRODE LIFTED. DEVICE DAMAGED. BEFORE THE PROCEDURE, THE SPLINES OF THE CATHETER WERE FOUND BENT WHEN THE PACKAGE WAS JUST OPENED. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. DEVICE WAS NOT USED IN PATIENT. ADDITIONAL INFORMATION WAS RECEIVED. THE DAMAGE DID NOT RESULT IN WIRES BEING EXPOSED. THE DAMAGE DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. THERE WAS NO RESISTANCE OR DIFFICULTY DURING INSERTION OR REMOVAL OF THE CATHETER. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 20-AUG-2024, THE SPLINE WAS BENT AND AN ELECTRODE WAS LIFTED AND DENTED. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF AN ELECTRODE LIFTED ON 20-AUG-2024 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20220201 ↗
• MalfunctionAug 29, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV AND DURING THE OPERATION, THE DEVICE WAS NOT IRRIGATING. THERE WAS NO ERROR NOTED FROM THE IRRIGATION PUMP. THE ISSUE WAS DISCOVERED WHEN THE CATHETER WAS NORMALLY PRE-FLUSHED, IT WAS FOUND THAT THE CATHETER DOES NOT RELEASE WATER. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20101878 ↗
• MalfunctionJul 2, 2024Display or Visual Feedback Problem; Material Twisted/Bent; Display or Visual Feedback Problem; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THAT SOME ELECTRODES APPEARED LIFTED. INITIALLY IT WAS REPORTED VISUALIZATION ISSUE AND SPLINE BENT ISSUES. DURING THE PROCEDURE, DEVICE WAS RECOGNIZED BY THE CARTO SYSTEM BUT ITS BRANCHES WERE NOT VISUALIZED ON THE CARTO SYSTEM. THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT. IT WAS FOUND THAT THE SPLINES OF THE CATHETER WERE BENT. PROVIDED A PICTURE. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED. THE DAMAGE DID NOT RESULT IN WIRES BEING EXPOSED. THE DAMAGE DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. THERE WAS RESISTANCE OR DIFFICULTY DURING INSERTION OR REMOVAL OF THE CATHETER. THE CATHETER WAS NOT PRE-SHAPED. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 06-JUN-2024, OBSERVED MULTIPLE SPLINES BENT AND SOME ELECTRODES APPEARED LIFTED. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19658080 ↗
• MalfunctionJul 1, 2024Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A REDDISH MATERIAL ON LIFTED AND SHARP ELECTRODES. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THEY HAD NOISY ELECTROGRAMS ON SOME OF THE PENTARAY CATHETER SPLINES ON THE CARTO 3 SYSTEM. THE CALLER DID NOT RECALL WHICH SPLINES WERE EDDECTED. REPLACING THE CATHETER CABLE DID NOT RESOLVE THE ISSUE. REPLACING THE CATHETER RESOLVED THE ISSUE AND THE PROCEDURE WAS CONTINUED AND SUBSEQUENTLY COMPLETED. THE CUSTOMER'S REPORTED NOISE ISSUE 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 (B)(6)2024, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A REDDISH MATERIAL ON LIFTED AND SHARP ELECTRODES. THESE FINDING WERE REVIEWED AND ASSESSED AS MDR REPORTABLE MALFUNCTIONS SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19652536 ↗
• MalfunctionJun 5, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND IT WAS NOT IRRIGATING. IT WAS REPORTED THAT DURING PROCEDURE, DEVICE WAS NOT IRRIGATING. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. ADDITIONAL INFOMRATION WAS RECEIVED INDICATING THE ISSUE WAS OBSERVED DURING USE. NO PUMP WAS USED, THEY USE THE PRESSURE BAG PROVIDED BY THE HOSPITAL. NO WATER IS FOUND WHEN THE SHEATH IS CHANGED BY PRESSURIZING AND FLUSHING AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19473781 ↗
• MalfunctionApr 24, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND THE DEFLECTION BECAME STUCK. IT WAS REPORTED THAT DURING THE OPERATION, CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. ON 7-APR-2024, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE CATHETER WAS STUCK IN A DEFLECTED POSITION. THE KNOB WAS UNABLE TO BE TURNED OR PUSHED DOWN, BUT THERE WAS NO DIFFICULTY REMOVING THE CATHETER. THE CATHETER WAS BEING USED WITH A SYNAPTIC 8.5F LONG SHEATH. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF ADDITIONAL INFORMATION ON 7-APR-2024 AND REASSESSED THE EVENT AS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19175670 ↗
• MalfunctionMar 14, 2024Coagulation in Device or Device Ingredient; Improper or Incorrect Procedure or Method; Coagulation in Device or Device Ingredient; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL TACHYCARDIA RIGHT (R-AT) PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND A CLOT ISSUE OCCURRED. THE PHYSICIAN MADE A RIGHT ATRIAL MAP WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. WHEN HE WAS FINISHED USING THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND WAS GOING TO PULL IT OUT OF THE RIGHT ATRIUM, HE SAW VIA THE ULTRASOUND IMAGE OF HIS ACUNAV INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER THAT THERE WERE CLOTS ON THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. HE PROCEEDED TO PULL THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER OUT OF THE BODY AND IT WAS NOT NEEDED FOR THE REMAINDER OF THE CASE. NO MEDICAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THE CLOTS ON THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WERE DUE TO NORMAL SALINE BEING USED FOR THE CONTINUOUS PRESSURE DRIP INSTEAD OF HEPARINIZED SALINE, WHICH WAS A MISTAKE IN COMMUNICATING WITH THE STAFF. THE PHYSICIAN INITIALLY THOUGHT THAT MAYBE THE PATIENT ALREADY HAD CLOTS IN THEIR INFERIOR VENA CAVA (IVC) BECAUSE IT WAS DIFFICULT TO MANEUVER THE CATHETER FROM THE START OF THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18907308 ↗
• MalfunctionJan 8, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND THE CATHETER WOULD NOT IRRIGATE. PENTARAY IS ALWAYS CONNECTED TO A PRESSURIZED FLUSH BAG. WHEN RE-INSERTING BACK INTO THE SHEATH, THEY MANUALLY FLUSHED AND OBSERVED DRIPS AT THE BASE OF PENTARAY SPLINES. THEY ATTEMPTED TO MANUALLY FLUSH WITH SYRINGE WHEN PRESSURIZED FLUSH BAG FAILED. THE DEVICE WAS USED WITH A SALINE BAG WITH HEPARIN. THE CATHETER WAS REPLACED AND THE CASE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18469175 ↗
• InjuryOct 17, 2022Break; Patient Device Interaction Problem; Break; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN ATRIAL FLUTTER LEFT (L-AFL) ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. THE PATIENT SUFFERED A FOREIGN BODY DUE SPLINE BEING STRIPPED OFF BY THE MECHANICAL VALVE. IT WAS REPORTED THAT WHILE MAPPING IN THE LEFT ATRIUM, NEAR THE LEFT ATRIAL APPENDAGE THAT THEY PULLED THE CATHETER BACK AND THE CATHETER BECAME WEDGED IN THE MECHANICAL VALVE. WHEN THEY TRIED TO PULL OUT THE CATHETER PART OF THE ELECTRODE ON THE SPLINE OF THE PENTARAY CATHETER WAS STRIPPED OFF BY THE MECHANICAL VALVE. THE PATIENT WAS STABLE WENT THEY LEFT THE PROCEDURE ROOM. THE PATIENT HAS A MECHANICAL MITRAL VALVE AND THE DOCTOR WAS ADVISED AND WAS ALSO INFORMED OF THE CONTRAINDICATIONS OF THE USE OF THE PENTARAY CATHETER. BROKEN TIP IS MDR-REPORTABLE. SINCE THE EVENT 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.

  Patient problems: Foreign Body In Patient

  MAUDE report 15613509 ↗
• MalfunctionSep 6, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT A PERSISTENT A-FIB/ATRIAL FLUTTER - RIGHT ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. A WHITE HAIR OR FIBER WAS DISCOVERED ON THE TIP OF THE CATHETER. IT WAS REPORTED THAT UPON OPENING THE PACKAGING OF THE CATHETER, A WHITE HAIR OR FIBER WAS DISCOVERED ON THE TIP OF THE CATHETER. THEY REPLACED THE CATHETER AND THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED. FOREIGN MATERIAL ON USABLE LENGTH OF CATHETER IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15359338 ↗
• InjuryJul 12, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD MALE PATIENT UNDERWENT AN PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT PRIOR TO ABLATION, DURING MAPPING IN THE LEFT ATRIUM WITH THE PENTARAY, ANESTHESIA PERSONNEL NOTED HYPOTENSION. USING FLUORO IMAGING, THEY NOTED THAT THE HEART BORDER WAS NOT MOVING AS NORMAL. ICE (INTRACARDIAC ECHOCARDIOGRAPHY) WAS USED TO CHECK THE HEART, AND A PERICARDIAL EFFUSION WAS NOTED. PERICARDIOCENTESIS WAS PERFORMED, AND FLUID AMOUNT WITHDRAWN IS UNKNOWN AS IT WAS AUTO-TRANSFUSED BACK TO THE PATIENT. THIS ADVERSE EVENT WAS DISCOVERED DURING USE OF BWI PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS UNKNOWN. THE PATIENT OUTCOME OF THE ADVERSE EVENT IS STABLE. THE PATIENT DID REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. TWO TRANSSEPTAL PUNCTURES WERE PERFORMED WITH A COOK NEEDLE. ABLATION WAS NOT PERFORMED PRIOR TO NOTING THE PERICARDIAL EFFUSION. THERE WAS NO EVIDENCE OF STEAM POP AS NO ABLATION WAS PERFORMED. THE EVENT OCCURRED DURING MAPPING. NO ERROR MESSAGES WERE O

  Patient problems: Cardiac Tamponade

  MAUDE report 14984015 ↗
• InjuryFeb 17, 2021Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE AND SUFFERED CARDIAC ARREST REQUIRING CARDIOPULMONARY RESUSCITATION (CPR) AND LEFT HEART CATHETERIZATION. AFTER PERFORMING THE FIRST TRANSSEPTAL PUNCTURE AND WHILE MAPPING THE LEFT ATRIUM (LA) THE PATIENT'S VITAL SIGNS BEGAN TO DROP. THE PHYSICIAN NOTICED A DROP IN BLOOD PRESSURE AND HEART RATE. AN INTERVENTIONAL CARDIOLOGIST WAS PAGED, CPR AND A LEFT HEART CATHETERIZATION WERE PERFORMED. THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND SOUNDSTAR(R) ECO DIAGNOSTIC ULTRASOUND CATHETER WERE IN THE BODY WHEN THE PATIENT'S VITAL SIGNS STARTED DECLINING AND THE ABLATION CATHETER WAS LATER INTRODUCED TO PACE THE HEART. NO ABLATION HAD BEEN PERFORMED AT THIS POINT. THE CALLER STATED THAT THERE WERE NO FINDINGS (ANOMALIES) FROM THE LEFT HEART CATHETERIZATION. THE PHYSICIAN ALSO USED THE SOUNDSTAR CATHETER TO CONFIRM THERE WAS NO EFFUSION OR PERFORATIONS. THE PATIENT WAS STABILIZED, HIS CONDITION IMPROVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER COMPLICATIONS. PHYSICIAN'S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. NO BWI PRODUCT MA

  Patient problems: Cardiac Arrest

  MAUDE report 11339947 ↗
• MalfunctionJun 26, 2020Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER, AND THE BIOSENSE WEBSTER INC. PRODUCT ANALYSIS LAB IDENTIFIED A SPLINE RING LIFTED. IT WAS REPORTED THAT DURING A LEFT SIDED ATRIAL FLUTTER ABLATION PROCEDURE, THERE WAS ECG NOISE FROM TWO OF THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER SPLINES ON THE CARTO 3 SYSTEM AND EP RECORDING SYSTEMS. THE ISSUE BEGAN AFTER THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WAS REMOVED AND THEN RE-INSERTED IT INTO THE PATIENT. THE CATHETER WAS EXCHANGED TO RESOLVE THE NOISE, THE PROCEDURE WAS CONTINUED SUCCESSFULLY. DAMAGED/FAULTY PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER SPLINES WERE THE CAUSE OF THE ISSUE REPORTED. THE CARTO 3 SYSTEM WAS OPERATING PER SPECIFICATIONS. NO PATIENT CONSEQUENCES WERE REPORTED. THE NOISE ISSUE WAS ASSESSED AS NOT REPORTABLE. THE PATIENT'S HEART RHYTHM WAS STILL VISIBLE TO THE OPERATOR WHEN THE SIGNAL NOISE OR LOSS ONLY AFFECTS ONLY THE BODY SURFACE (BS) OR INTRACARDIAC (IC) ELECTROGRAMS (BUT NOT BOTH). WITH THE INFORMATION AVAILABLE, THERE WAS NO INDICATION THAT THE ELECTRODES WERE DAMAGED OR THAT INTERNAL CATHETER COMPONENTS WERE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10203197 ↗
• MalfunctionJan 31, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT UPON ARRIVAL OF THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER SHIPMENT, IT WAS NOTICED THAT THE PACKAGING WAS DAMAGED WITH PUNCTURE HOLES THROUGH TO THE STERILE INNER POUCH. THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER NEVER USED ON PATIENT. NO PATIENT CONSEQUENCES WERE REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. ON JANUARY 22, 2020, THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION, AND IT WAS NOTED THAT UPON INITIAL VISUAL INSPECTION, THE OUTER BOX HAS SHIPPING DAMAGE. THE PRODUCT WAS RETURNED IN ORIGINAL OUTER BOX AND THE POUCH WAS UNOPENED (NEVER USED). THE PUNCTURE POINTS REPORTED BY THE CUSTOMER WERE NOT VISIBLE WITH VISUAL INSPECTION. THE FIRST VISUAL INSPECTION IS ASSESSED AS NOT REPORTABLE; HOWEVER, THE FILE REMAINS MDR REPORTABLE FOR THE CUSTOMER'S INITIALLY REPORTED ISSUE. FURTHER ANALYSIS IS PENDING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9655987 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123837. One submission often covers many models, so check the product and lot details in each record.

• Z-0211-2018 · May 17, 2017 · Terminated
  PENTARAY NAV High-Density Mapping Catheter.
• Z-1591-2016 · Apr 14, 2016 · Terminated
  Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is
• Z-1176-2014 · Feb 20, 2014 · Terminated
  PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211. The Biosense Webster