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Dynamic XT™ M0042011010Recalls & reported problems

Boston Scientific Corporation · Unidirectional Steerable Diagnostic Catheter · Class 2

Quick summary

This Boston Scientific Dynamic XT steerable diagnostic catheter is used to map heart rhythms and guide ablation procedures. The 35 reports mostly describe the catheter cracking or breaking at the tip, becoming stuck or tangled in small vein branches so it could not be advanced or withdrawn, and sending noisy or unstable mapping signals that led to cancelled procedures. Reports also describe fluid around the heart needing drainage and low blood pressure; 2 deaths and 11 injuries were reported. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
36
Deaths reported
2
Injuries reported
12
Recalls naming it
0

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 08714729877615), received between Aug 2, 2018 and Aug 4, 2026 — classified as 2 deaths, 12 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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.

Reports received per month

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 2 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 2 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem13
  • Detachment of Device or Device Component3
  • Difficult to Remove3
  • Signal Artifact/Noise3
  • Defective Device2
  • Difficult to Advance2
  • Electrical /Electronic Property Problem2
  • Material Perforation2

Patient problems

  • No Clinical Signs, Symptoms or Conditions14
  • No Consequences Or Impact To Patient7
  • Pericardial Effusion7
  • Cardiac Tamponade5
  • Low Blood Pressure/ Hypotension4
  • Tachycardia2
  • Atrial Fibrillation1
  • Cardiac Arrest1

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

    It was reported that Pericardial effusion and Cardiac Tamponade occurred.Dynamic XT Electrode Catheter was selected for Single Shot Ablation procedure. It was mentioned that the preparation of the materials (Faradrive sheath and VersaCross Connect wire with dilator) for the transseptal puncture, as well as the advancement of the catheter into the right atrium, proceeded smoothly without any issues. The transseptal puncture was performed under transesophageal echocardiography (TEE) guidance. The physician positioned the transseptal puncture device. Initially, the tenting appeared slightly anterior; however, it was not close to the aorta and was located in the region of the patent foramen ovale (PFO). The physician performing the TEE requested a slight adjustment to optimize the puncture site. Repositioning the device was achieved without difficulty. RF was delivered using the transseptal puncture generator. The wire crossed the interatrial septum in an inferior position, well away from the aorta. After confirming the wire position by both TEE and fluoroscopic imaging, it was visualized in the left superior pulmonary vein. The physician then advanced the Faradrive sheath into the lef

    Patient problems: Cardiac Tamponade; Pericardial Effusion; Pericarditis

    MAUDE report 50133533 ↗
  • MalfunctionJan 5, 2026Material Perforation; Positioning Problem

    IT WAS REPORTED THAT THE DISTAL PORTION OF THE CATHETER SHAFT WAS DAMAGED. DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT PAROXYSMAL ATRIAL FIBRILLATION, A DYNAMIC XT ELECTRODE CATHETER WAS USED. AFTER INSERTION, IT WAS NOTED THAT THERE WAS DIFFICULTY IN POSITIONING THE DEVICE, AND THE MOVEMENT OF THE CATHETER WAS NOT AS SMOOTH AS USUAL. THE CATHETER WAS THEN WITHDRAWN FOR INSPECTION, WHEREIN A CRACK WAS OBSERVED ON THE DISTAL PORTION OF THE CATHETER SHAFT. ANOTHER OF THE SAME DEVICE WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23956642 ↗
  • InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT BECAME HYPOTENSIVE AND HAD A PERICARDIAL EFFUSION REQUIRING DRAINAGE. DURING A PULMONARY VEIN ISOLATION (PVI) AND SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE, A DYNAMIC XT ELECTRODE CATHETER WAS USED. AT THE START OF THE CASE, THE PHYSICIAN ATTEMPTED AN ELECTROPHYSIOLOGY (EP) STUDY; HOWEVER, PLACEMENT OF THE CORONARY SINUS (CS) CATHETER WAS EXTREMELY DIFFICULT DUE TO PATIENT'S ANATOMY. THE PHYSICIAN ALTERNATED BETWEEN A DYNAMIC DECAPOLAR CS CATHETER AND AN ABBOTT LIVEWIRE DUODECAPOLAR CATHETER FOR APPROXIMATELY AN HOUR TO GAIN CS ACCESS, BUT CS ACCESS COULD NOT BE ACHIEVED, AND THE EP STUDY PROCEEDED WITHOUT IT. AFTER ADMINISTRATION OF ISUPREL, THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE. INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CONFIRMED A TRIVIAL PERICARDIAL EFFUSION, WHICH INCREASED SLIGHTLY UPON RE-EVALUATION A MINUTE LATER. CONTINUED MONITORING REVEALED PROGRESSIVE ENLARGEMENT OF THE EFFUSION, WHICH PROMPTED THE USE OF A PERICARDIAL SYNTHESIS KIT TO DRAIN APPROXIMATELY 200 CC OF BLOOD. PROTAMINE WAS ADMINISTERED, AND THE EFFUSION SUBSEQUENTLY STABILIZED. THE PATIENT REMAINED STABLE THROUGHOUT THE INTERVENTION AND WAS KEPT OVERNIGHT FO

    Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

    MAUDE report 23866200 ↗
  • InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT AFTER THE ABLATION PROCEDURE WAS PERFORMED WITH DYNAMIC XT ELECTRODE CATHETER, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. DRAINAGE WAS PERFORMED. THE PHYSICIAN BELIEVES THAT THE CORONARY SINUS GOT PERFORATED. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR FURTHER SURGICAL PROCEDURES. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS AS IT HAS ALREADY BEEN DISPOSED.

    Patient problems: Pericardial Effusion

    MAUDE report 23705602 ↗
  • MalfunctionNov 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE DEVICE IS BROKEN AND DETACHED AT THE CATHETER TIP. A DYNAMIC XT ELECTRODE CATHETER WAS SELECTED FOR USE. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23593930 ↗
  • MalfunctionApr 29, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

    IT WAS REPORTED THAT DIFFICULT TO WITHDRAW AND DIFFICULT TO ADVANCE. DURING RADIO FREQUENCY PROCEDURE TO TREAT ATRIAL FLUTTER AT SIDE BRANCH TO THE SINUS CORONARIUS, A DYNAMIC XT WAS SELECTED FOR USE. IT WAS OBSERVED THAT THE CATHETER WAS ENTANGLED IN A SIDE BRANCH TO THE SINUS CORONARIUS. WHEN THE CATHETER WAS REMOVED, THERE WAS SOME KIND OF DEFECT BETWEEN ELECTRODES 1 AND 2 AND IT GOT STUCK IN A SIDE BRANCH TO SINUS CORONARIUS AND IT COULDN'T GET IT OUT. NO RESISTANCE FELT WHILE MANEUVERING THE CATHETER. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURN FOR ANALYSIS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21928645 ↗
  • MalfunctionApr 29, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

    IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO WITHDRAW AND DIFFICULT TO ADVANCE. DURING A PROCEDURE TO TREAT A SUPRAVENTICULAR TACHYCARDIA AT SINUS CORONARIUS, A DYNAMIC XT CATHETER WAS SELECTED FOR USE. IT WAS OBSERVED THAT THE CATHETER WENT ENTRAPPED IN A SIDE BRANCH TO SINUS CORONARIUS. IT COULD NOT BE WITHDRAWN OR PUSHED FORWARD. THE CATHETER HAD TO BE ROTATED COUNTERCLOCKWISE TO BE REMOVED. THERE WAS A NOTICEABLE DAMAGE AT THE TIP BETWEEN THE DISTAL TIP ELECTRODE AND POLE 2, IT LOOKS LIKE THE DIAMETER IS SLIGHTLY LARGER, IT WASN'T SURE IF THAT DEFECT WAS CREATED AFTER THE CATHETER GOT STUCK AND THEY TRIED TO ROTATE IT OUT. IF THIS DEFECT WAS THERE FROM THE BEGINNING, NO ONE KNOWS. THE PHYSICIAN DIDN'T HAVE TROUBLE INSERTING THE DEVICE. IT WAS 5 OR 6 F OF THE SIZES AND TYPES OF SHEATHS. CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC PRODUCT. THERE WERE NO PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURN FOR ANALYSIS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21928403 ↗
  • MalfunctionMar 25, 2025

    DECA CATHETER WOULD NOT BEND CORRECTLY FOR MD (MEDICAL DOCTOR). CATHETER WAS REMOVED AND REPLACED WITH NEW ONE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21686863 ↗
  • MalfunctionAug 23, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

    IT WAS REPORTED THAT DURING A PROCEDURE, A DYNAMIC XT STEERABLE DIAGNOSTIC CATHETER WAS SELECTED FOR USE. CATHETER ELECTRODE MAPPING SIGNAL WAS UNSTABLE. PROCEDURE WAS UNABLE TO BE COMPLETED AND HAD TO BE CANCELLED/RESCHEDULED. NO DAMAGE AND NO PATIENT COMPLICATIONS WERE NOTED. CATHETER IS EXPECTED TO BE RETURNED FOR FURTHER ANALYSIS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20050135 ↗
  • DeathFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT PATIENT DEATH OCCURRED FOLLOWING A PROCEDURE WHILE USING TWO INTELLAMAP ORION CATHETERS AND A DYNAMIC XT STEERABLE DIAGNOSTIC CATHETER. DURING MAPPING AND ABLATION PROCEDURE TO TREAT A LEFT ACCESSORY PATHWAY ARRYTHMIA, THE INTELLAMAP ORION CATHETER WAS NOTED TO BE HARD TO MANIPULATE BECAUSE IT WAS BENT. THE PHYSICIAN REPLACED THE FIRST ORION BECAUSE THE CATHETER WAS NOT REACTED PROPERLY TO MANEUVERS. THE ISSUE WAS RESOLVED WITH THE SECOND CATHETER. THE DYNAMIC XT STEERABLE DIAGNOSTIC CATHETER WAS PLACED IN THE CORONARY SINUS (CS). WHILE THE PHYSICIAN WAS MANIPULATING THE ORION CATHETER IN BETWEEN THE AORTA AND THE LEFT VENTRICLE THE PATIENT FELT PAIN, THE PHYSICIAN REALIZED THEY SUFFERED A LEFT VENTRICLE CARDIAC TAMPONADE. IT WAS UNKNOWN IF THE TAMPONADE WAS CAUSED BY THE FIRST OR SECOND ORION CATHETER. THE TAMPONADE OCCURRED PRIOR TO ABLATION; NO ABLATION CATHETER WAS USED. PERICARDIOCENTESIS WAS PERFORMED. INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGING WAS PERFORMED TO ATTEMPT TO LOCATE A SUSPECTED PERFORATION. THE PROCEDURE WAS NOT COMPLETED. THE PATIENT DIED THE FOLLOWING DAY. THE CAUSE OF DEATH WAS RELATED TO THE TAMPONADE. NO FURTHER INFORMATION ON PATIENT C

    Patient problems: Cardiac Tamponade

    MAUDE report 18788394 ↗
  • InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    OT WAS REPORTED THAT FOLLOWING A PROCEDURE USING A DYNAMIC XT STEERABLE DIAGNOSTIC CATHETER THE PATIENT EXPERIENCED CARDIAC TAMPONADE. THE PROCEDURE HAD BEEN COMPLETED SUCCESSFULLY AND WHILE IN THE RECOVERY AREA THE PATIENT BECAME TACHYCARDIC, HYPOTENSIVE, AND DIAPHORETIC. AN ECHO WAS PERFORMED, AND TAMPONADE WAS IDENTIFIED. A PERICARDIOCENTESIS WAS PERFORMED AND THE EFFUSION WAS RESOLVED. THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION AND DISCHARGED THE FOLLOWING DAY. THEY ARE EXPECTED TO MAKE A FULL RECOVERY. THE CAUSE OF THE EFFUSION COULD NOT BE DETERMINED. THE CATHETER IS NOT AVAILABLE FOR RETURN AS IT WAS DISPOSED OF AFTER THE PROCEDURE WAS COMPLETED.

    Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Tachycardia

    MAUDE report 18187358 ↗
  • InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FLUTTER (AF) USING AN INTELLANAV STABLEPOINT OPEN-IRRIGATED CATHETER, INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER, AND A DYNAMIC XT CATHETER, THE PATIENT EXPERIENCED CARDIAC TAMPONADE. TOWARDS THE END OF THE PROCEDURE THE PATIENT'S BLOOD PRESSURE DECREASED. AN ECHOCARDIOGRAM WAS PERFORMED AND SHOWED PERICARDIAL EFFUSION. DRAINAGE REMOVED 1500ML OF FLUID, AFTER WHICH THE PATIENT'S BLOOD PRESSURE IMPROVED. THEN, HEPARIN WAS REVERSED, AND BLOOD PRODUCTS WERE GIVEN. THE PATIENT'S BLOOD PRESSURE DROPPED AGAIN, AND THE SURGEONS WERE CONSULTED. DURING THE WAITING PERIOD THE PATIENT'S BLOOD PRESSURE CRASHED. RIGHT VENTRICULAR COLLAPSE OCCURRED, AND SURGERY WAS INITIATED. THE SURGERY WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS MOVED TO THE INTENSIVE THERAPY UNIT FOR RECOVERY. NO PERFORATION WAS FOUND DURING SURGERY AND THE CAUSE OF THE TAMPONADE WAS NOT DETERMINED.

    Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

    MAUDE report 17597233 ↗
  • InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    CLINICAL PATIENT ID (B)(6). DURING A PROCEDURE TO TREAT ATRIAL FIBRILLATION A DYNAMIC XT ELECTRODE CATHETER WAS USED. PRIOR TO DISCHARGE NO MORE THAN 2 DAYS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN DUE TO PLEUROPERICARDIAL INFLAMMATION. THE PATIENT WAS PRESCRIBED COLCHICINE AND THE PAIN WAS RESOLVED BY DAY 7. THERE WAS INDICATION IF PRODUCT WILL BE RETURNED.

    Patient problems: Chest Pain

    MAUDE report 17166373 ↗
  • MalfunctionApr 4, 2023Signal Artifact/Noise

    ATHETER INSERTED INTO BODY; NOISE NOTED ON PROXIMAL ELECTRODES. NO NEW CATHETER REQUESTED PER MD.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16673045 ↗
  • MalfunctionJan 17, 2023Unsealed Device Packaging; Unsealed Device Packaging

    IT WAS REPORTED THAT THE PACKAGING OF THE DYNAMIC XT 10 CATHETER WAS DAMAGED DURING TRANSPORT. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR LABORATORY ANALYSIS SINCE IT HAS BEEN DISCARDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16183750 ↗
  • MalfunctionJan 9, 2023Physical Resistance/Sticking

    ELECTROPHYSIOLOGY INSERTED INTO PATIENT BUT REMOVED DUE TO RESISTANCE ON PLUNGER PER OPERATING PHYSICIAN. NO HARM TO PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16120465 ↗
  • MalfunctionSep 24, 2022Material Perforation; Material Perforation

    IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE USING AN DYNAMIC XT CATHETER THAT THE SHAFT OF THE CATHETER WAS BROKEN. THE CATHETER WAS EXCHANGED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THE CATHETER IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15477692 ↗
  • InjuryMar 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    LOCALIZE CLINICAL STUDY - SUBJECT ID: (B)(6). IT WAS REPORTED THAT A PROCEDURE INVOLVING AN INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER, INTELLANAV STABLEPOINT OPEN-IRRIGATED AND DYNAMIC XT CATHETERS WAS COMPLETED ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT EXPERIENCED EFFUSIVE PERICARDITIS WITH FEVER, AND SEVERE PERICARDIAL EFFUSION WITHOUT TAMPONADE. AN ECHOCARDIOGRAPH WAS PERFORMED TO DIAGNOSE THE ISSUE. A PERICARDIAL DRAINAGE WAS CONDUCTED, AND THIS ISSUE IS ONGOING.

    Patient problems: Pericardial Effusion

    MAUDE report 13672464 ↗
  • InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    (B)(6) STUDY. IT WAS REPORTED THAT A INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER, TWO INTELLANAV STABLEPOINT CATHETERS AND A DYNAMIC XT CATHETER WAS USED IN A MAPPING AND ABLATION PROCEDURE. DURING THE PROCEDURE IT WAS NOTED THAT PATIENT CARDIAC TAMPONADE OCCURRED, A ECHOCARDIOGRAPHY WAS PERFORMED TO CONFIRM. THE EVENT WAS RESOLVED WITH A PERICARDIAL DRAINAGE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: Pericardial Effusion

    MAUDE report 13579967 ↗
  • InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE INVOLVING A INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER, THREE VIKING ELECTRODE CATHETERS, AND AN DYNAMIC XT CATHETER, THE PATIENT EXPERIENCED TAMPONADE. THE EVENT REQUIRED INVASIVE INTERVENTION TO RESOLVE AND PROLONGATION OF HOSPITALIZATION, HOWEVER THE DETAILS OF THE INTERVENTION WERE NOT SPECIFIED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE DEVICES ARE NOT EXPECTED TO BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

    Patient problems: Cardiac Tamponade

    MAUDE report 12920829 ↗
  • MalfunctionDec 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT A DYNAMIC XT WAS SELECTED TO BE USED IN A ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA (AVNRT) ABLATION PROCEDURE. PRIOR TO THE PROCEDURE IT WAS NOTED THAT THE CATHETER SNAPPED BEFORE USE IN A PATIENT. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS BEING REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12917403 ↗
  • MalfunctionNov 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21OCT2021. IT WAS REPORTED THAT BEFORE A PROCEDURE TO TREAT ATRIAL FIBRILLATION A DYNAMIC XT CATHETER WAS SELECTED FOR USE. THE SHAFT WAS BENT WHILE REMOVING THE PACKAGING, THE PACKAGE WAS IN GOOD CONDITIONS. THE ISSUE WAS SOLVED BY EXCHANGING THE CATHETER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THE TIP WAS DETACHED FROM THE SHAFT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12790392 ↗
  • MalfunctionJul 1, 2021Failure to Analyze Signal

    POOR SIGNALS FROM CATHETER, NO INJURY TO PT, TROUBLESHOT BY CHANGING THE PIN BLOCK AND THE CABLE. NEW CATHETER USED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12099453 ↗
  • InjuryApr 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER, INTELLANAV ST, AND DYNAMIC XT CATHETERS WERE USED IN A RHYTHMIA MAPPING PROCEDURE. DURING THE PROCEDURE THE PATIENT EXPERIENCED A STROKE. THE PATIENT WAS NOT ABLE TO SPEAK DISTINCTLY DURING THE PROCEDURE. THE PROCEDURE WAS ENDED AND THE PATIENT WAS NOTED TO BE ABLE TO SPEAK THE FOLLOWING DAY. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: Ischemia Stroke

    MAUDE report 11695325 ↗
  • InjuryJan 26, 2021Difficult to Remove; Difficult to Remove

    IT WAS REPORTED THAT AT THE END OF A PROCEDURE TO TREAT ATRIAL FIBRILLATION WITH A DYNAMIC XT ELECTRODE CATHETER, THE PATIENT WAS IN ATRIAL FIBRILLATION. THE PHYSICIAN PROCEEDED TO PERFORM AN INTERNAL SHOCK (41J) THEN AN EXTERNAL (200J). HE THEN TRIED TO REMOVE THE CATHETER PRESENT IN THE DISTAL PORTION OF THE CORONARY SINUS, WHICH WAS STUCK / STUCK TO THE WALL (HEATING DUE TO INTERNAL ELECTRIC SHOCK). THE PHYSICIAN USED AN NON-BOSTON SCIENTIFIC SHEATH IN ORDER TO REMOVE THE CATHETER FROM THE CORONARY SINUS (HE CUT THE HANDLE OF THE CATHETER) AND SUCCEEDED IN REMOVING THE CATHETER FROM THE PATIENT. EXTRACTION WAS PERFORMED BY GENTLE AND PROGRESSIVE PRESSURE. THERE WAS NO PERICARDIAL EFFUSION AT EXTRACTION AND AT 10 MINUTES. THE PATIENT WAS WELL AND DID NOT ENCOUNTER ANY OTHER PROBLEMS. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

    Patient problems: Atrial Fibrillation

    MAUDE report 11230591 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.