Starter™ Guidewire M001491561Recalls & reported problems

Summary

The FDA's MAUDE database contains 116 adverse event reports that list this exact device (DI 08714729326731), received between Feb 21, 2022 and Sep 30, 2026 — classified as 2 deaths, 28 injuries, 86 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (33 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 116 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948485 ↗
• MalfunctionSep 24, 2026Fracture

  Event Description: We received a defective item; the following information is provided: Product: M001491561 UPN: M001491561 - ROSEN GUIDE 0.035 J TIP 1.5MM Lot Number: 8315979 Model: M001491561 BSC Notification Date: 08/28/2026 Product Available for Return? Yes Note: Guide wire disintegrated upon insertion into the catheter. · What type of procedure was performed? Faraview ablation Date: 08/19/2026 · What was the specific anatomical location? Left atrium · When did the incident occur (e.g., during the procedure, during preparation/before use, etc.)? During the procedure · What was used to complete the procedure (this device, another device of the same type, a different device (different model))? Was another device of the same type used? · Were there any complications for the patient resulting from this event? No · Did the patient's clinical condition remain stable after the procedure? Yes What was the outcome of the procedure (procedure successfully completed, procedure canceled, completed by an alternative method)? Procedure successfully completed. Material is available for analysis. Yes · Please provide the following information about the physician: first and last name, clinic na

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876653 ↗
• MalfunctionSep 24, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876559 ↗
• MalfunctionSep 23, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876472 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Event Description: eCN Event Description: The tension dropped when passing to the right we had time to do the first balloon application before seeing that the tension was much too low and therefore effusion. What troubleshooting steps took place? What troubleshooting steps, if any, resolved the issue?: No troubleshooting needed What is the next course of action?: Just to hear from the patient Patient present at time of event?: Yes Adverse/Unintended Patient Events: Cardiac Tamponade In the physician's opinion, did the device or procedure contribute to the adverse or unintended patient event?: Yes Please explain how the device or procedure contributed?: Because of the J tip Medical or Surgical Interventions: Chest surgery Reason for unsuccessful procedure: The patient's blood pressure has dropped Based on the outcome noted above, was the patient sedated when the procedure was cancelled?: Yes - General Anesthesia Device Acquired from a Distributor?: No.Event Date: 2026-9-7.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 50855970 ↗
• MalfunctionSep 16, 2026Contamination

  Event Description: Per CNF, It was reported that: -Event; Damage -Was there any appearance abnormality before use?"[?]" No -At what location and what kind of damage was observed?"[?]" The insulation has peeled off, and the internal wire was exposed. Note: For any Patient Information field(s) left blank in the CNF - 'Asked but not available as per account. In addition, the e-mail address of the physician, who was also the initial reporter, was not available. Physician Comments: Patient Outcome: No Adverse Event Infected: No Generator/controller: Ablation Catheter Used: Other used:Event Date: 2026-8-25

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50789673 ↗
• DeathAug 30, 2026Adverse Event Without Identified Device or Use Problem

  Event Description: Per CNF, It was reported that: Event: A patient injury has occurred. Please indicate the details of patient injury observed into the patient: Cardiac Tamponade. Please indicate the details about the event that leads to patient injury. During the BB procedure, there was a pacemaker lead located near the septum, which caused difficulties; after one unsuccessful attempt, the procedure was repeated after repositioning and was successful. During the PVI procedure, the procedure was carried out in the order LS, LI, RI; whilst performing RIPV, it was discovered that the blood pressure was dropping whilst repositioning several times, and treatment for cardiac tamponade was initiated. Please indicate the details about the treatment for the patient injury that occurred. After performing the drainage procedure, information regarding the decision on whether to proceed to surgery is not available. Please indicate the condition of the patient after the treatment. Unknown. Please indicate the view of the attending physician regarding the cause on the occurrence of patient injury. Unknown. Was there a problem with the appearance or functionality of this device? No problem. Was t

  Patient problems: Cardiac Tamponade

  MAUDE report 50514825 ↗
• InjuryAug 18, 2026Entrapment of Device; Difficult to Remove

  eCN Event Description: Ablations performed in Left Pulmonary veins, no issues noted. Physician having issues attempting to wire RPVs. What troubleshooting steps took place? What troubleshooting steps, if any, resolved the issue?: Deployed 'flower' conformation when FARAWAVE catheter partially in sheath. Non-recoverable. What is the next course of action?: New FARAWAVE catheter opened. Patient present at time of event?: Yes

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50298101 ↗
• MalfunctionAug 12, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222369 ↗
• InjuryJul 30, 2026Entrapment of Device

  Device/Procedure Outcome: Procedure Completed,Unable to Use Device - Attempted,Different Device Used (Same Model)Patient Outcome: F26: No Health Consequences or Impact.Event Description: Per CNF, It was reported that: -Event; It was stuck. -Please indicate the details leading up to the event in which it got stuck.; While approaching the LI, the catheter and guidewire did not move at all. When it was forcibly pulled from the body along with the catheter, tissue was found trapped between the catheter and the guidewire. -Please specify the physician's opinion on the cause of the device being stuck; It is possible that the issue was caused by the roof-side portion rubbing against the tissue, as the transition from the flower configuration to the basket configuration was performed within the pulmonary vein in LI. -Please indicate how it was released from being stuck; While approaching the LI, the catheter and guidewire did not move at all. When it was forcibly pulled from the body along with the catheter, tissue was found trapped between the catheter and the guidewire. -Were there any other catheters in the heart when it got stuck?; No -Was the ORION catheter used as a concomitant devic

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50082353 ↗
• MalfunctionJul 29, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50077210 ↗
• MalfunctionJul 29, 2026Fracture; Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50075603 ↗
• MalfunctionJul 27, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50046662 ↗
• InjuryJul 12, 2026Adverse Event Without Identified Device or Use Problem

  ECN EVENT DESCRIPTION: NO EFFUSION ON PRE-PROCEDURE CHECK. TRANSEPTAL PUNCTURE WITH AGILIS SHEATH AND BAYLIS RF WIRE, WAS AS PLANNED DESPITE WIRE ONLY TRACKING RSPV IN THE BEGINNING: CONFIRMED NOT AORTIC WITH BUBBLE VISUALIZATION UPON PUNCTURE, AND WIRE VISUALIZATION WITH ICE AFTER REPOSITIONING INTO THE LSPV. PROCEDURE WENT AS PLANNED COMPLETING PVI WITH OLIVE LESIONS AND PWI WITH FARAWAVE 31 MM CATHETER. THE LSPV WAS THEN WIRED AND A CARDIOVERSION WAS PERFORMED WITH FARAWAVE CATHETER STILL DWELLING INSIDE LEFT ATRIUM. ADDITIONAL LESIONS WERE GIVEN TO LSPV ALONG WITH EXIT BLOCK PACING MANEUVERS AND PHYSICIAN RETRACTED CATHETER INTO AGILIS SHEATH AND ENTIRE SYSTEM WAS RETRACTED INTO RIGHT ATRIUM. PHYSICIAN UTILIZED ICE TO COMPLETE A POST PROCEDURE EFFUSION CHECK AND SAW A SIZABLE EFFUSION ON THE INFERIOR/POSTERIOR RIGHT ATRIUM/RIGHT VENTRICULAR AREA. ATTEMPTS WERE MADE TO COMPLETE A PERICARDIOCENTESIS, HOWEVER, DUE TO BODY HABITUS THE PHYSICIAN WAS UNABLE TO PERFORM AND CARDIOTHORACIC SURGERY WAS CALLED. CARDIOTHORACIC SURGERY SHOWED UP AFTER A 20 MINUTE WAIT AND DECIDED THAT TAKING THE PATIENT TO THE OPERATING ROOM WAS THE BEST CLINICAL DECISION. IN THE OR, A PERICARDIAL WINDOW WA

  Patient problems: Pericardial Effusion

  MAUDE report 25791421 ↗
• MalfunctionApr 29, 2026Entrapment of Device

  DEVICE/PROCEDURE OUTCOME: PROCEDURE COMPLETED, UNABLE TO USE DEVICE - ATTEMPTED, DIFFERENT DEVICE USED (SAME MODEL) PATIENT OUTCOME: F26: NO HEALTH CONSEQUENCES OR IMPACT. EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: "[?]"EVENT"[?]"STUCK GUIDEWIRE "[?]"WHEN DID IT OCCUR?"[?]"DURING THE PROCEDURE "[?]"WHAT TYPE OF GUIDEWIRE WAS USED?"[?]"COMPATIBLE GUIDEWIRE "[?]"IF THE GUIDEWIRE WAS A BSC DEVICE, WHAT WAS THE LOT OR J-POS NUMBER?"[?]""[?]"WAS A NEW GUIDEWIRE USED TO CONTINUE THE PROCEDURE OR WAS THE SAME GUIDEWIRE USED?"[?]"YES "[?]"WAS THE GUIDEWIRE REMOVED AS USUAL?"[?]"IT WAS REMOVED BY FORCE "[?]"DID YOU EXPERIENCE ANY RESISTANCE WHILE MANIPULATING THE GUIDEWIRE?"[?]"YES "[?]"WAS THE GUIDEWIRE MOVED IN AND OUT OF THE CATHETER SEVERAL TIMES?"[?]"YES "[?]"HOW LONG WAS THE COAGULATION TIME (ACT) WHEN THE STUCK OCCURRED?"[?]"300 "[?]"PLEASE DESCRIBE IN DETAIL HOW IT HAPPENED; DURING THE PROCEDURE, WHEN ATTEMPTING TO WITHDRAW THE GUIDEWIRE, IT COULD NOT BE PULLED BACK. THE CATHETER ITSELF COULD BE REMOVED, INDICATING THAT THE GUIDEWIRE WAS NOT CAUGHT IN TISSUE. AFTER REMOVING THE CATHETER, THE GUIDEWIRE WAS FORCIBLY PULLED OUT AND REMOVED; HOWEVER, IT WAS NO LONGER USABLE. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25029656 ↗
• MalfunctionMar 16, 2026Difficult to Advance

  EVENT DESCRIPTION: ECN EVENT DESCRIPTION: FARAWAVE OPENED AND PREPPED ON BACK TABLE WITH NO ISSUE. FARAWAVE INSERTED INTO 13F AGILIS SHEATH, ROSEN WIRE WAS DIFFICULT TO ADVANCE OUT PAST THE TIP OF THE DEVICE (CATHETER WAS STILL IN SHEATH, ATTEMPTING TO LEAD WITH WIRE). FARAWAVE WAS REMOVED AND NEW ROSEN WIRE WAS USED. CATHETER WAS RE-INSERTED ALONG WITH WIRE, GUIDED UP TO LA. ABLATIONS STARTED AT LSPV IN 'BASKET' NO ISSUE. PHYSICIAN DEPLOYED 'FLOWER' AND TRIED TO ADVANCE WIRE FURTHER INTO VEIN, NOTICED SIGNIFICANT RESISTANCE WHEN EITHER ADVANCING OR RETRACTING WIRE. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: SWAPPED OUT ROSEN FOR NEW GUIDEWIRE CHECKED FOR OCCLUSION BY MANUALLY FLUSHING GUIDEWIRE LUMEN WITH SYRINGE NO OCCLUSION NOTED. WHAT IS THE NEXT COURSE OF ACTION?: NEW FARAWAVE CATHETER OPENED. PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS PATIENT OUTCOME: FULLY RECOVERED PROCEDURE NUMBER: (B)(4) EVENT DATE: 2026-3-4 AS REPORTED DEVICE CODES: 1274: DIFFICULT TO ADVANCE AS REPORTED PATIENT CODES: 9398: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS COUNTRY OF EVENT: UNITED STATES RELATED PRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24602966 ↗
• InjuryMar 15, 2026Adverse Event Without Identified Device or Use Problem

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: EVENT: OCCURRENCE OF HEALTH INJURY PLEASE PROVIDE DETAILS OF THE HEALTH DAMAGE OBSERVED IN THE PATIENT; DUE TO PERICARDIAL EFFUSION DETECTED ON ECHOCARDIOGRAPHY, PERICARDIAL DRAINAGE WAS PERFORMED. PLEASE PROVIDE THE DETAILS OF THE PROCESS LEADING UP TO THE OCCURRENCE OF HEALTH DAMAGE; IT SEEMS THAT THE PATIENT'S HEART IS SLIGHTLY TILTED, MAKING IT DIFFICULT TO OPERATE THE BROCKENBROUGH SHEATH. THE BROCKENBROUGH SHEATH IS ALSO INSERTED INTO THE LEFT ATRIUM WITHOUT ANY ELECTRICAL STIMULATION. PLEASE PROVIDE THE DETAILS OF THE MEASURES OF THE HEALTH DAMAGE THAT OCCURRED; TOWARD THE END OF THE PFA PROCEDURE, THE BLOOD PRESSURE HAD DROPPED FROM WHEN THE PATIENT ENTERED THE ROOM. AN ECHO EXAMINATION WAS PERFORMED, WHICH CONFIRMED THE PRESENCE OF PERICARDIAL EFFUSION, SO PERICARDIAL DRAINAGE WAS CARRIED OUT. THE AMOUNT OF BLEEDING IN THE CATHETERIZATION ROOM WAS AROUND 150CC. AFTERWARD, THE PATIENT WAS TRANSFERRED TO THE ICU. WHAT IS THE PATIENT'S CONDITION AFTER THE PROCEDURE? WHAT IS THE DOCTOR'S OPINION ON THE CAUSE OF THE HEALTH DAMAGE?; IT IS BEING SUGGESTED THAT THE RIGHT ATRIUM MAY HAVE BEEN INJURED DURING THE SHEATH MANIPULATION W

  Patient problems: Pericardial Effusion

  MAUDE report 24601550 ↗
• InjuryMar 15, 2026Adverse Event Without Identified Device or Use Problem

  EVENT DESCRIPTION: ECN EVENT DESCRIPTION: DURING THE PROCEDURE, THE PHYSICIAN PERFORMED THE FIRST TRANSSEPTAL, CROSSED WITH THE WIRE, AND DECIDED TO PERFORM A SECOND TRANSSEPTAL. THE PHYSICIAN EXCHANGED FOR THE CATHETER AND BEGAN ABLATING WHEN NOTICING A DROP IN PRESSURE AND EFFUSION. THE ABLATION WAS COMPLETED AND THE REMOVED FROM THE LA AS A PERICARDIOCENTESIS WAS PREPPED AND PERFORMED. PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: PERICARDIAL EFFUSION IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION?: YES PLEASE DESCRIBE THE WAY IN WHICH THE DEVICE OR PROCEDURE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATION?: A PERFORATION LIKELY OCCURRED DURING TRANSSEPTAL OR DURING THE ABLATION MEDICAL OR SURGICAL INTERVENTIONS: PERICARDIOCENTESIS PATIENT ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE: YES PATIENT DISCHARGED FROM HOSPITAL?: NO PATIENT OUTCOME: THE ISSUE IS ONGOING PROCEDURE NUMBER: PN-3059043 EVENT DATE: 2026-3-2 AS REPORTED DEVICE CODES: 2099: NO KNOWN DEVICE PROBLEM AS REPORTED PATIENT CODES: 9221: PERICARDIAL EFFUSION, 9213: PERFORATION COUNTRY OF EVENT: UNITED STATES RETURNED PRODUCT EXPECTED: NO R

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 24601548 ↗
• MalfunctionMar 11, 2026Fracture; Difficult to Remove

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: AROUND THE RSPV, THE WIRE WAS ONCE RETRACTED INTO THE CATHETER, AND WHEN AN ATTEMPT WAS MADE TO ANCHOR IT AGAIN, IT GOT STUCK, THE WIRE PROTRUDED SLIGHTLY FROM THE TIP AND IT COULD NO LONGER BE ADVANCED. WHILE PULLING BACK THE CATHETER AND SHEATH, THE CATHETER WAS SAFELY RETRACTED INTO THE SHEATH, AND IT WAS REMOVED FROM THE BODY, PART OF THE FIBER LIKE STRUCTURE WAS FOUND CAUGHT AT THE TIP OF THE WIRE LUMEN; THEREFORE, THE CATHETER AND WIRE WERE REPLACED, AND THE EVENT WAS RESOLVED. AT PRESENT, THERE IS NO INFORMATION INDICATING ANY COMPLICATIONS. NOTE: FOR ANY PATIENT INFORMATION FIELD(S) LEFT BLANK IN THE CNF: 'ASKED BUT NOT AVAILABLE AS PER ACCOUNT.' IN ADDITION, THE EMAIL ADDRESSES OF BOTH THE PHYSICIAN AND THE INITIAL REPORTER WERE NOT AVAILABLE. PHYSICIAN COMMENTS: PATIENT OUTCOME: NO ADVERSE EVENT INFECTED: NO GENERATOR/CONTROLLER: ABLATION CATHETER USED: OTHER USED: DEVICE/PROCEDURE OUTCOME: PROCEDURE COMPLETED, UNABLE TO USE DEVICE. ATTEMPTED, DIFFERENT DEVICE USED (SAME MODEL). PATIENT OUTCOME: F26: NO HEALTH CONSEQUENCES OR IMPACT. AS REPORTED DEVICE CODES: 1457: ENTRAPMENT OF DEVICE OR DEVICE COMPONENT. AS REPORTED PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575212 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: - EVENT; OCCURRENCE OF HEALTH PROBLEMS. - PLEASE PROVIDE DETAILS OF THE HEALTH PROBLEMS OBSERVED IN THE PATIENTS; THE PATIENT DEVELOPED CARDIAC TAMPONADE FROM THE LEFT ATRIAL APPENDAGE. THE EVENT OCCURRED IN A MANNER WHERE THE LEFT ATRIAL APPENDAGE WAS SCRATCHED. - WHAT ARE THE DETAILS OF THE EVENTS LEADING UP TO THE OUTBREAK OF THE HEALTH HAZARD? AFTER USING THE VERSA CROSS CONNECT AND PERFORMING A SEPTAL PUNCTURE, A PIGTAIL CATHETER WAS ADVANCED INTO THE LEFT ATRIAL APPENDAGE. DURING PRE-MAPPING WITH OCTARAY, A SUDDEN DROP IN BLOOD PRESSURE WAS OBSERVED, AND CARDIAC TAMPONADE WAS DETECTED. THE PATIENT WAS THEN TRANSPORTED TO THE OPERATING ROOM FOR OPEN CHEST SURGERY. SUBSEQUENT ECHOCARDIOGRAPHY REVEALED THAT THE PIGTAIL CATHETER WAS DEFORMED, WITH THE TIP EXTENDING OUTSIDE THE CIRCULAR AREA AND MAKING CONTACT WITH THE LEFT ATRIAL APPENDAGE. - PLEASE PROVIDE DETAILS ON THE TREATMENT OF HEALTH HAZARDS THAT HAVE OCCURRED.; THE CARDIAC TAMPONADE WAS RESOLVED THROUGH OPEN CHEST SURGERY. NO LIFE SUPPORT DEVICES WERE USED. --WHAT WAS THE PATIENT'S CONDITION AFTER THE PROCEDURE? - WHAT WAS YOUR PHYSICIAN'S OPINION ON THE CAUSE OF THE HEAL

  Patient problems: Cardiac Tamponade

  MAUDE report 24545640 ↗
• MalfunctionMar 3, 2026Entrapment of Device

  RELATED PRODUCT MODEL#: 42415, RELATED PRODUCT SERIAL#: NO VALUE FOUND, RELATED PRODUCT UPN#: M001491561, RELATED PRODUCT BATCH/LOT: 0009671298, RELATED PRODUCT FAMILY: STARTER, MATERIAL NUMBER: M001491561, RETURNED PRODUCT EXPECTED: NO. DEVICE/PROCEDURE OUTCOME: PROCEDURE COMPLETED, UNABLE TO USE DEVICE - ATTEMPTED, DIFFERENT DEVICE USED (SAME MODEL). PATIENT OUTCOME: F26: NO HEALTH CONSEQUENCES OR IMPACT. EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: EVENT; [FARAWAVE] SPLINE FAILURE (INVERSION, BENDING, DAMAGE, ETC.). WHEN DID IT OCCUR? DURING PROCEDURE. WHAT TYPE OF GUIDEWIRE WAS USED? STARTER WIRE. WAS THE SHEATH STRAIGHT OR BENT UPON RETRACTING THE SPLINE INTO THE SHEATH? IT MIGHT HAVE BEEN BENT. WAS THE SPLINE INVERSION ABLE TO BE RESOLVED IN THE BODY? IT COULD NOT BE INSERTED FROM THE START. WAS THE CATHETER SUCCESSFULLY PULLED OUT FROM THE PATIENT? IT COULD NOT BE INSERTED FROM THE START. WHEN ROTATING THE SPLINE BETWEEN ABLATION, WAS THE CATHETER RETRACTED FIRST FROM THE TISSUE? IT COULD NOT BE INSERTED FROM THE START. DID THE PATIENT HAVE DIFFICULT ANATOMICAL STRUCTURES THAT MIGHT HAVE CONTRIBUTED TO SPLINE FAILURE? NONE IN PARTICULAR. WAS THERE IMAGES AVAILABLE? IF P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496856 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  RELATED PRODUCT MODEL #: 42415. RELATED PRODUCT SERIAL #: NO VALUE FOUND. RELATED PRODUCT UPN #: M001491561. RELATED PRODUCT BATCH/LOT: 0009671426. RELATED PRODUCT FAMILY: STARTER. MATERIAL NUMBER: M001491561. STERILE LOT NUMBER: NO VALUE FOUND. SOLD TO ACCOUNT NUMBER: NO VALUE FOUND. RETURNED PRODUCT EXPECTED: NO. BSC PRODUCT RETURN DATE: NO VALUE FOUND. LOCATION DESCRIPTION: NO VALUE FOUND. DEVICE/PROCEDURE OUTCOME: ORIGINAL DEVICE USED, PROCEDURE COMPLETED PATIENT OUTCOME: F19: SURGICAL INTERVENTION. EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: AFTER ABLATION, THE PATIENT DEVELOPED CARDIAC TAMPONADE SHORTLY AFTER RETURNING TO THE HOSPITAL WARD, AND AN OPEN CHEST PROCEDURE IS SCHEDULED ON THURSDAY. NOTE: FOR ANY PATIENT INFORMATION FIELD(S) LEFT BLANK IN THE CNF - "ASKED BUT NOT AVAILABLE AS PER ACCOUNT" INFECTED: NO INFECTION NAME: DIAGNOSIS OR TREATMENT: RESOLUTION: COMPLETED WITH THIS DEVICE WHERE DID EVENT OCCUR: INSIDE THE PATIENT OUTCOME: ADVERSE EVENT FIRST TIME THE UNIT WAS USED: TESTED PRIOR TO USE: USED BEFORE EXPIRY DATE: GENERATOR USED ABLATION[?]CATHETER USED OTHER USED EVENT DATE: 2026-1-30. AS REPORTED DEVICE CODES: 2099: NO KNOWN DEVICE PROBLEM. AS REPORTED P

  Patient problems: Cardiac Tamponade

  MAUDE report 24447438 ↗
• InjuryFeb 22, 2026Adverse Event Without Identified Device or Use Problem

  DEVICE/PROCEDURE OUTCOME: PROCEDURE CANCELLED/RESCHEDULED PATIENT OUTCOME: F23: UNEXPECTED MEDICAL INTERVENTION, F08: HOSPITALIZATION OR PROLONGED HOSPITALIZATION, 104: CANCELLED/RESCHEDULED - POST SEDATION/SEDATION UNKNOWN. EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: [?]EVENT; HEALTH INJURY [?]PLEASE SPECIFY THE DETAILS OF HEALTH INJURY; CARDIAC TAMPONADE HAS OCCURRED AND PERICARDIOCENTESIS WAS PERFORMED. [?]PLEASE SPECIFY THE DETAILS LEADING UP TO THE OCCURRENCE OF HEALTH INJURY; TAMPONADE HAS OCCURRED DURING PRE-MAPPING WITH FARAWAVE. [?]PLEASE SPECIFY THE DETAILS OF THE TREATMENT FOR THE OCCURRED HEALTH INJURY; PERICARDIOCENTESIS WAS PERFORMED AND THE PROCEDURE HAD BEEN DISCONTINUED. [?]PLEASE SPECIFY THE PATIENT'S CONDITION AFTER THE TREATMENT; THE PATIENT RETURNED TO THE WARD AFTER THE PERICARDIOCENTESIS. [?]PLEASE SPECIFY THE PHYSICIAN'S OPINION ABOUT THE CAUSE OF THE HEALTH INJURY; THE CAUSE OF CARDIAC TAMPONADE WAS UNKNOWN, HOWEVER, THE PHYSICIAN SUSPECTED THAT IT WAS NOT CAUSED BY THE WIRE. [?]WAS THERE ANY PROBLEM WITH THE APPEARANCE OR FUNCTIONALITY OF THE DEVICE?; NO ISSUES WERE NOTED. [?]WAS THERE ANY OTHER CATHETER IN THE HEART WHEN THE HEALTH INJURY OCCURRED?;

  Patient problems: Cardiac Tamponade

  MAUDE report 24410667 ↗
• MalfunctionFeb 11, 2026Entrapment of Device

  DEVICE/PROCEDURE OUTCOME: ORIGINAL DEVICE USED, PROCEDURE COMPLETED PATIENT OUTCOME: F26: NO HEALTH CONSEQUENCES OR IMPACT. EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: EVENT: GUIDEWIRE STUCK WHEN DID IT OCCUR? AT THE END OF THE CASE, APPLICATION WAS PERFORMED ON THE RIPV. OCCURRED AFTER POST-MAP. WHAT TYPE OF GUIDEWIRE WAS USED? STARTER IF THE GUIDEWIRE WAS A BSC DEVICE, WHAT WAS THE LOT OR J-POS NUMBER? TO BE CONFIRMED WAS A NEW GUIDEWIRE USED TO CONTINUE THE PROCEDURE OR WAS THE SAME GUIDEWIRE USED? PROCEDURE ENDED AS IS WAS THE GUIDEWIRE ABLE TO BE REMOVED NORMALLY? NO WAS THERE ANY RESISTANCE DURING MANIPULATION OF THE GUIDEWIRE? YES WAS THE GUIDEWIRE MOVED IN AND OUT OF THE CATHETER SEVERAL TIMES? YES HOW MANY ACTS AT THE TIME OF THE STUCK OF BLOOD CLOTTING TIME? TO BE CONFIRMED PLEASE PROVIDE DETAILS ON HOW THIS OCCURRED. EVENT: GUIDEWIRE STUCK WHEN DID IT OCCUR? AT THE END OF THE CASE, APPLICATION WAS PERFORMED ON THE RIPV. OCCURRED AFTER POST-MAP. WHAT TYPE OF GUIDEWIRE WAS USED? STARTER IF THE GUIDEWIRE WAS A BSC DEVICE, WHAT WAS THE LOT OR J-POS NUMBER? TO BE CONFIRMED WAS A NEW GUIDEWIRE USED TO CONTINUE THE PROCEDURE OR WAS THE SAME GUIDEWIRE USED? PROCEDURE ENDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312880 ↗
• MalfunctionFeb 8, 2026Fracture

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: [?]EVENT: GUIDEWIRE STUCK [?]WHEN DID IT OCCUR?; PRESHAPE [?]WHAT TYPE OF GUIDEWIRE WAS USED?; STARTER [?]IF THE GUIDEWIRE WAS A BSC DEVICE, WHAT WAS THE LOT OR J-POS NUMBER?; [?] WAS A NEW GUIDEWIRE USED TO CONTINUE THE PROCEDURE OR WAS THE SAME GUIDEWIRE USED?; NEW GUIDE WIRE [?]WAS THE GUIDEWIRE ABLE TO BE REMOVED NORMALLY?; DIFFERENT WIRE [?]WAS THERE ANY RESISTANCE DURING MANIPULATION OF THE GUIDEWIRE?; NO [?]WAS THE GUIDEWIRE MOVED IN AND OUT OF THE CATHETER SEVERAL TIMES?;NOTHING IN PARTICULAR [?]HOW MANY ACTS AT THE TIME OF THE STUCK OF BLOOD CLOTTING TIME ?; [?]PLEASE PROVIDE DETAILS ON HOW THIS OCCURRED; DURING PRE-SHAPING, IT CANNOT BE DEPLOYED. THE WIRE CANNOT BE INSERTED OR REMOVED. PHYSICIAN COMMENTS: PATIENT OUTCOME: NO ADVERSE EVENT INFECTED: NO GENERATOR/CONTROLLER: ABLATION CATHETER USED: OTHER USED:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288317 ↗