Reflexion SpiralRecalls & reported problems across all models

We found 2 models of Reflexion Spiral by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Sep 21, 2016 and May 1, 2023 — classified as 1 death, 11 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (8 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Reflexion Spiral problems

Reflexion Spiral models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Reflexion Spiral™ D402893

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  1 death19 reports
• Reflexion Spiral™ 402804

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  13 reports

Recent Reflexion Spiral adverse event reports

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

• MalfunctionMay 1, 2023Fracture; Fracture

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THERE WAS A FRACTURE FOUND IN THE CATHETER SHAFT. AT THE END OF THE PROCEDURE, THE DAMAGE WAS OBSERVED BY X-RAY. IN THE PROXIMAL PART OF THE SHAFT, ABOUT 2 CM PROXIMAL TO THE NUMBER 20 POLE. AT THAT TIME THE PROCEDURE WAS FINISHED WITH NO ISSUES. THE PHYSICIAN ATTEMPTED TO PULL THE CATHETER INSIDE THE SHEATH, BUT IT WAS NOT POSSIBLE. INSTEAD, THE SHEATH AND CATHETER WERE REMOVED TOGETHER. THE DAMAGE ON THE CATHETER COULD THEN BE SEEN. THE INSULATE OF THE PROXIMAL PART WAS BROKEN AND A LITTLE WIRE WAS EXPOSED. THE SIGNALS WERE STABLE THROUGHOUT THE PROCEDURE, AND THE ONLY ISSUE WAS IN THE ANTERIOR DEFLECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16841896 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE BEGINNING OF AN ATRIAL FIBRILLATION PROCEDURE, WHEN MAPPING WAS STARTED WITH THE TACTICATH SE AND REFLEXION SPIRAL CATHETER, AN ACUTE PERICARDIAL EFFUSION WAS NOTED ON THE ICE IMAGE. THE ATRIAL FIBRILLATION CASE WAS BEGUN, TRANSSEPTAL WAS PERFORMED AND LEFT ATRIAL MAPPING GEOMETRY COMMENCED. THE PHYSICIAN THOUGHT THE GEOMETRY LOOKED ODD AND ASKED TO SEE THE PRIOR STUDY FROM (B)(6) 2017. AFTER REVIEWING THAT STUDY HE RETURNED TABLESIDE TO CONTINUE AND NOTED AN EFFUSION ON THE ICE IMAGE. THE PROCEDURE WAS STOPPED AND A PERICARDIOCENTESIS WAS PERFORMED. THERE WERE MULTIPLE PERFORATIONS ON THE LEFT SIDE OF THE HEART. THE CARDIOVASCULAR SURGEON IN HOUSE WAS NOTIFIED AND THE PATIENT WAS EVENTUALLY TAKEN TO HAVE A PRESUMED PERFORATION REPAIRED. THE PATIENT WAS EXTUBATED (B)(6) AND IS STABLE. THERE WAS NO ALLEGED ISSUE WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 15996391 ↗
• MalfunctionSep 29, 2022Fracture; Fracture

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE CATHETER BROKE DURING INSERTION THROUGH THE SHEATH; INTERNAL WIRES WERE EXPOSED. THE CATHETER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508617 ↗
• MalfunctionSep 28, 2022Fracture; Fracture

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE CATHETER FRACTURED WHILE MAPPING IN THE LEFT ATRIUM. THE CATHETER WAS ABLE TO BE REMOVED WITHOUT COMPLICATION AND EXCHANGED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15498576 ↗
• MalfunctionJun 29, 2022Material Separation; Material Separation

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE CATHETER SHAFT SEPARATED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14859185 ↗
• MalfunctionJul 6, 2021Fracture; Material Frayed; Fracture; Material Frayed

  TOWARDS THE END OF THE PROCEDURE, AS THE DEVICE WAS REMOVED, THE TIP OF THE SHAFT WAS FRACTURED AND A SHARP WIRE WAS STICKING OUT OF THE CATHETER. THE INTERNAL WIRING OF THE CATHETER CUT THROUGH THE COVERING OF THE CATHETER, EXPOSING THE WIRE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12120351 ↗
• MalfunctionMar 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PAROXYSMAL FIBRILLATION ABLATION PROCEDURE, A BLOOD LEAK WAS NOTED AT THE CATHETER HANDLE APPROXIMATELY HALF WAY THROUGH THE PROCEDURE. THEN, DURING THE VEIN ISOLATION, BLOOD WAS NOTED TO BE DRIPPING FROM THE SAME LOCATION. THE PROCEDURE WAS CONTINUED WITH THE SAME CATHETER AND EVENTUALLY COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11440029 ↗
• MalfunctionAug 26, 2020Fracture; Fracture

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS, CONFIRMING A SHAFT FRACTURE ON THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10454297 ↗
• InjuryAug 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3008452825-2020-00429, 3008452825-2020-00430, 3008452825-2020-00431, 3008452825-2020-00432, 3005334138-2020-00374. DURING AN PAROXYSMAL ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. NEAR THE END OF THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE. A TRANSTHORACIC ECHOCARDIOGRAM CONFIRMED A PERICARDIAL EFFUSION, FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE DURING THE PROCEDURE. THE PATIENT HAS REMAINED IN STABLE CONDITION.

  Patient problems: Cardiac Perforation

  MAUDE report 10431393 ↗
• InjuryJul 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3008452825-2020-00308, 3008452825-2020-00309, 3008452825-2020-00310. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AFTER THE TRANSSEPTAL PUNCTURE HAD BEEN PERFORMED, AND GEOMETRY WAS BEING COLLECTED, THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION, FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 10275389 ↗
• MalfunctionJun 25, 2020Material Frayed; Material Frayed

  TOWARD THE END OF AN ATRIAL FIBRILLATION PROCEDURE, SLIGHT RESISTANCE WAS NOTED WHEN THE CATHETER WAS REMOVED FROM THE PATIENT. WHEN THE DEVICE WAS REMOVED, THE OUTER MATERIAL ON THE CATHETER LOOP WAS FRAYED, EXPOSING THE INTERNAL COMPONENTS. ADDITIONALLY, THE ELECTRODES WERE DISPLACED FROM THEIR ORIGINAL POSITIONS. NO ANOMALIES WERE NOTED WHILE MAPPING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DEVICES ARE STORED IN THEIR ORIGINAL PACKAGING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10195442 ↗
• MalfunctionApr 21, 2020Material Frayed; Material Frayed

  THIS EVENT IS BEING REPORTED BASED ON THE ANALYSIS OF THE RETURNED DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9980930 ↗
• InjuryFeb 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3008452825-2020-00100, 3005334138-2020-00065, 3008452825-2020-00101, 3008452825-2020-00102. FOLLOWING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A CARDIAC TAMPONADE OCCURRED. SEVEN HOURS POST PROCEDURE THE PATIENT EXPERIENCED BACK PAIN. AN ECHOCARDIOGRAM WAS PERFORMED WHICH REVEALED A CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 9746238 ↗
• MalfunctionFeb 11, 2020Material Frayed; Material Frayed

  DURING A PROCEDURE THERE WAS AN INSULATION SEPARATION AT THE DISTAL END OF THE SHAFT, THOUGH THERE WERE NO EXPOSED INTERNAL COMPONENTS. THE DEVICE WAS REPLACED AND THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9696143 ↗
• MalfunctionFeb 6, 2020Material Frayed; Activation, Positioning or Separation Problem; Material Frayed; Activation, Positioning or Separation Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE CATHETER WOULD NOT DEFLECT AS INTENDED WHILE MAPPING. THE CATHETER WAS REMOVED FROM THE PATIENT AND UPON VISUAL INSPECTION, THE INSULATION OF THE CATHETER SHAFT HAD SPLIT. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9676032 ↗

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