VersaCross Access Solution VXSK0032 (REF NA)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00685447011835), received between May 22, 2023 and May 22, 2025 — classified as 8 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. Jun 10, 2025Open, Classified

   Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.

   Z-2103-2025 · Root cause: Packaging change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT VERSACROSS ACCESS SOLUTION WAS SELECTED FOR PULSE FIELD ABLATION FARAPULSE PROCEDURE. DURING THE PROCEDURE, IT WAS MENTIONED THAT WHEN THE PHYSICIAN OPENED THE VERSACROSS ACCESS SOLUTION, THE RF WIRE WAS NOTED BROKEN INSIDE THE SEALED PACKAGE. AS THE DEVICE CAN NOT BE USED, IT WAS REPLACED WITH ANOTHER SAME MODEL KIT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070535 ↗
• MalfunctionMar 10, 2025Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED THAT A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR AN ATRIAL FIBRILLATION (A FIB) ABLATION PROCEDURE. DURING THE PROCEDURE, IT WAS CONFIRMED THROUGH ICE THAT THE RF WIRE WAS EXPOSED AND TENTING APPROPRIATELY. HOWEVER, THE RF WIRE WOULD NOT CROSS WHEN RF WAS APPLIED. THE RF SETTINGS WERE ADJUSTED TO 2 SECONDS, YET NO CHANGE OBSERVED. IN ADDITION, REWIRING AND REPOSITIONING THE RF WIRE DID NOT RESULT IN A CHANGE EITHER. NEXT, THE RF WIRE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS REPORTED. PRODUCT IS AVAILABLE FOR RETURN. IT HAS BEEN FURTHER MENTIONED THAT RF WAS DELIVERED AND THE RF TONE WAS HEARD FROM THE BMC RF GENERATOR BUT THE WIRE WOULD NOT CROSS. TENTING WAS OBSERVED BEFORE ATTEMPTED CROSSING AND WIRE TIP WAS OUT OF THE DILATOR. CROSSING WAS ATTEMPTED 5 TIMES AND RF WAS APPLIED EACH TIME. NO OTHER ISSUES WERE NOTED. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561535 ↗
• InjuryAug 30, 2024Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  A PERFORATION AND A PERICARDIAL EFFUSION (PE) OCCURRED. IT WAS REPORTED THAT A VERSACROSS CONNECT LAAC ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A WATCHMAN PROCEDURE. PRIOR TO THE PROCEDURE, A BASELINE PE WAS IDENTIFIED IN THE PATIENT (GREATER THAN 1CM). FOLLOWING THE COMPLETION OF THE PROCEDURE, HAVING THE WATCHMAN DEVICE IMPLANTED WITHOUT ISSUE, THE BASELINE PE WAS MONITORED, AND IT WAS DETERMINED THAT IT HAD WORSENED AROUND THE RIGHT VENTRICLE. A PERICARDIOCENTESIS WAS THEN PERFORMED, BUT THE RIGHT-SIDE EFFUSION SLOWLY RE-ACCUMULATED. NEXT, A SURGERY WAS PERFORMED, AND A PERFORATION OF THE RIGHT VENTRICLE APEX WAS DISCOVERED AND REPAIRED. IT WAS DETERMINED TO BE UNRELATED TO ANY IMPLANTATION OF THE WATCHMAN DEVICE, BUT LIKELY CAUSED BY THE VERSACROSS WIRE OR SHEATH INSERTED PRIOR/DURING TRANSEPTAL PUNCTURE. DURING TRANSSEPTAL PUNCTURE, LIMITED FLUORO WAS USED AND VERSACROSS WIRE WERE INSERTED IN THE SUPERIOR VENA CAVA (SVC) USING TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). IT IS THOUGHT THAT BEFORE THE WIRE/SHEATH COULD BE SEEN IN THE SVC, IT MAY HAVE DROPPED INTO THE RIGHT VENTRICLE CAUSING DAMAGE. PATIENT WAS SENT TO INTENSIVE CARE UNIT (ICU) FOR RECOVERY, PARTIALLY DUE TO OTHER

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 20107370 ↗
• InjuryAug 30, 2024Display or Visual Feedback Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Display or Visual Feedback Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  A PERFORATION AND A PERICARDIAL EFFUSION (PE) OCCURRED. IT WAS REPORTED THAT A VERSACROSS CONNECT LAAC ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A WATCHMAN PROCEDURE. PRIOR TO THE PROCEDURE, A BASELINE PE WAS IDENTIFIED IN THE PATIENT (GREATER THAN 1CM). FOLLOWING THE COMPLETION OF THE PROCEDURE, HAVING THE WATCHMAN DEVICE IMPLANTED WITHOUT ISSUE, THE BASELINE PE WAS MONITORED, AND IT WAS DETERMINED THAT IT HAD WORSENED AROUND THE RIGHT VENTRICLE. A PERICARDIOCENTESIS WAS THEN PERFORMED, BUT THE RIGHT-SIDE EFFUSION SLOWLY RE-ACCUMULATED. NEXT, A SURGERY WAS PERFORMED, AND A PERFORATION OF THE RIGHT VENTRICLE APEX WAS DISCOVERED AND REPAIRED. IT WAS DETERMINED TO BE UNRELATED TO ANY IMPLANTATION OF THE WATCHMAN DEVICE, BUT LIKELY CAUSED BY THE VERSACROSS WIRE OR SHEATH INSERTED PRIOR/DURING TRANSEPTAL PUNCTURE. DURING TRANSSEPTAL PUNCTURE, LIMITED FLUORO WAS USED AND VERSACROSS WIRE WERE INSERTED IN THE SUPERIOR VENA CAVA (SVC) USING TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). IT IS THOUGHT THAT BEFORE THE WIRE/SHEATH COULD BE SEEN IN THE SVC, IT MAY HAVE DROPPED INTO THE RIGHT VENTRICLE CAUSING DAMAGE. PATIENT WAS SENT TO INTENSIVE CARE UNIT (ICU) FOR RECOVERY, PARTIALLY DUE TO OTHER

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 20107270 ↗
• InjuryJul 9, 2024Positioning Problem; Positioning Problem

  A PERFORATION AND A PERICARDIAL EFFUSION (PE) OCCURRED, PROCEDURE CANCELLED. DURING THE PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A WATCHMAN CASE. THE RIGHT FEMORAL VEIN WAS ACCESSED, AND THE VERSACROSS RF WIRE WAS ADVANCED INTO THE SUPERIOR VENA CAVA (SVC), AND THE VERSACROSS SHEATH WAS ADVANCED OVER THE RF WIRE. FOUR ATTEMPTS WERE MADE TO DROP ONTO THE INTERATRIAL SEPTUM (IAS), BUT WERE UNSUCCESSFULLY. THUS, THE VERSACROSS RF WIRE WAS EXCHANGED FOR THE J-TIP GUIDEWIRE. THE J-WIRE WAS THEN ADVANCED TOWARDS TO IAS ALONG WITH THE VERSACROSS AND THE PHYSICIAN WAS ABLE TO SUCCESSFULLY ENGAGED THE SEPTUM. THE J-WIRE WAS THE RE-EXCHANGED FOR THE VERSACROSS RF WIRE, RF WAS DELIVERED, AND LEFT ATRIUM (LA) ACCESS WAS ACHIEVED. THE WIRE WAS THEN ADVANCED INTO THE LEFT ATRIAL APPENDAGE (LAA), ATTEMPTS MADE TO ENGAGE THE LEFT SUPERIOR PULMONARY VEIN (LSPV) WITH THE VERSACROSS WIRE WERE UNSUCCESSFUL. THUS, IT WAS CHOSEN TO ADVANCE THE WIRE INTO THE RIGHT SUPERIOR PULMONARY VEIN (RSPV) INSTEAD. THE VERSACROSS SHEATH WAS THEN USED TO FLOSS THE SEPTUM AND THEN EXCHANGED FOR THE WATCHMAN SINGLE CURVE SHEATH. WHEN MANIPULATING THE VERSACROSS WIRE AND THE SHEATH FROM THE R

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 19706198 ↗
• InjuryApr 3, 2024Failure to Advance; Failure to Advance

  IT HAS BEEN REPORTED THAT A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE. A PERFORATION AND AN AORTIC HEMATOMA OCCURRED, AND THE PROCEDURE WAS CANCELLED. DURING THE PROCEDURE, THE PHYSICIAN MENTIONED THAT THEY WERE EXPERIENCING DIFFICULTIES VISUALIZING THE VERSACROSS CONNECT SYSTEM DUE TO THE LEADS THAT WERE PRESENT IN THE RIGHT ATRIUM. SINCE IT WAS NOT POSSIBLE TO ACHIEVE THEIR DESIRED LOCATION WITH THE VERSACROSS CONNECT SYSTEM, THESE DEVICES WHERE SWAPPED IT OUT FOR THE VERSACROSS ACCESS KIT. THUS, WITH IT, IT WAS POSSIBLE TO VISUALIZE TENTING AT A MID/SLIGHTLY ANTERIOR POINT. RADIO FREQUENCY (RF) WAS THEN APPLIED, AND IT DID NOT APPEAR THAT IT CROSSED, SO RF WAS APPLIED A SECOND TIME, AND YET STILL UNSUCCESSFUL CROSSING. ONCE PREPARING FOR THE THIRD ATTEMPT, WHILE CHECKING BACK TO THE SHORT AXIS TO MAKE SURE IT WAS STILL A GOOD SPOT, IT WAS DISCOVERED THAT THE PATIENT DEVELOPED AN AORTIC HEMATOMA. NO CHANGE IN EFFUSION SIZE WAS NOTED TO THE INITIALLY NOTED TRACE EFFUSION PRIOR TO PROCEDURE. PATIENT WAS STABLE DURING THE ENTIRE TIME. NO INTERVENTIONS WERE REQUIRED. THE PATIENT WAS SENT FOR A COMPUTED TOMOGRAPHY (CT) A

  Patient problems: Cardiac Perforation; Hematoma

  MAUDE report 19038335 ↗
• InjuryApr 3, 2024Positioning Problem; Positioning Problem

  IT HAS BEEN REPORTED THAT A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE. A PERFORATION AND AN AORTIC HEMATOMA OCCURRED, AND THE PROCEDURE WAS CANCELLED. DURING THE PROCEDURE, THE PHYSICIAN MENTIONED THAT THEY WERE EXPERIENCING DIFFICULTIES VISUALIZING THE VERSACROSS CONNECT SYSTEM DUE TO THE LEADS THAT WERE PRESENT IN THE RIGHT ATRIUM. SINCE IT WAS NOT POSSIBLE TO ACHIEVE THEIR DESIRED LOCATION WITH THE VERSACROSS CONNECT SYSTEM, THESE DEVICES WHERE SWAPPED IT OUT FOR THE VERSACROSS ACCESS KIT. THUS, WITH IT, IT WAS POSSIBLE TO VISUALIZE TENTING AT A MID/SLIGHTLY ANTERIOR POINT. RADIO FREQUENCY (RF) WAS THEN APPLIED, AND IT DID NOT APPEAR THAT IT CROSSED, SO RF WAS APPLIED A SECOND TIME, AND YET STILL UNSUCCESSFUL CROSSING. ONCE PREPARING FOR THE THIRD ATTEMPT, WHILE CHECKING BACK TO THE SHORT AXIS TO MAKE SURE IT WAS STILL A GOOD SPOT, IT WAS DISCOVERED THAT THE PATIENT DEVELOPED AN AORTIC HEMATOMA. NO CHANGE IN EFFUSION SIZE WAS NOTED TO THE INITIALLY NOTED TRACE EFFUSION PRIOR TO PROCEDURE. PATIENT WAS STABLE DURING THE ENTIRE TIME. NO INTERVENTIONS WERE REQUIRED. THE PATIENT WAS SENT FOR A COMPUTED TOMOGRAPHY (CT) A

  Patient problems: Cardiac Perforation; Hematoma

  MAUDE report 19038331 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMORAL VEIN PERFORATION, BLEEDING AND HYPOTENSION OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE FELLOW PHYSICIAN USED A NON-BOSTON SCIENTIFIC GUIDEWIRE TO GAIN FEMORAL VEIN ACCESS AND ANCHORED IT IN THE SUPERIOR VENA CAVA (SVC). THEN THE VERSACROSS SHEATH WAS ADVANCED WITHOUT PANNING DOWN TO THE GROIN WHICH WAS NOTED ONLY AFTER THE SHEATH NOT ABLE TO TRACK UP TO THE SVC. THE GUIDEWIRE WAS LOOPED AROUND IN THE FEMORAL VEIN AND THE VERSACROSS SHEATH WAS BOWING DOWN INSTEAD OF UP. THE PHYSICIAN REMOVED THE SHEATH AND STRAIGHTENED THE GUIDEWIRE. THEN A NON-BOSTON SCIENTIFIC 16 FRENCH INTRODUCER WAS USED OVER THE GUIDEWIRE AND RE-INSERTED THE SHEATH OVER THE GUIDEWIRE THROUGH THE 16 FRENCH INTRODUCER. THE SHEATH WAS PLACED IN THE SVC, THE GUIDEWIRE WAS SWAPPED OUT FOR THE VERSACROSS RF WIRE. THE TRANSSEPTAL PUNCTURE WAS PERFORMED SUCCESSFULLY AT AN INFERIOR-MID LOCATION AND THE WIRE WAS ADVANCED IN THE LEFT ATRIUM (NO ISSUES NOTED). THE VERSACROSS SHEATH WAS THEN SWAPPED WITH A WATCHMAN SHEATH. IT WAS NOTED THAT THE PATIENT BLOOD PRESSURE DROPPED

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Perforation; Perforation of Vessels; Swelling/ Edema

  MAUDE report 18995098 ↗
• MalfunctionMar 22, 2024Difficult to Insert; Material Integrity Problem; Difficult to Insert; Material Integrity Problem

  IT WAS REPORTED THAT A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. ONCE TRIED TO LOAD THE VERSACROSS RF WIRE, IT HAD A ROUGHED UP COATING (DAMAGE) AND IT WOULD NOT ADVANCE INTO VERSACROSS SHEATH. THUS, A NEW DEVICE WAS OPENED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. IT WAS FURTHER NOTED THAT THE ISSUE HAPPENED ONCE TRIED TO LOAD THE WIRE. THE VERSACROSS RF WIRE WOULD NOT ENTER THE SHEATH. THE ISSUE WAS NOTED WITH THE RF WIRE AND VERSACROSS SHEATH. IT WAS DIFFICULTY NOTED DURING BACKLOADING THE WIRE. THE PATIENT DID NOT HAVE ANY LEADS OR MECHANICAL HARDWARE. THE DAMAGE WAS NOTED ON THE WIRE BEFORE OR AFTER THE DIFFICULTY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18961558 ↗
• MalfunctionDec 18, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE DURING AN ATRIAL FIBRILLATION (A FIB) ABLATION. DURING THE PROCEDURE, THE SHEATH/DILATOR BECAME BENT/KINKED/DEFORMED, AND IT WAS NOTICED THAT THE INSULATION MATERIAL ON THE VERSACROSS RF WIRE AT THE PROXIMAL END WAS PULLING AWAY FROM THE DEVICE AND UNRAVELING. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE ISSUE WAS NOTED UPON OPENING THE PACKAGE. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18352920 ↗
• MalfunctionDec 6, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A PULMONARY VEIN ISOLATION PROCEDURE, A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. ONCE TRIED TO LOAD THE VERSACROSS RF WIRE INTO THE SHEATH, THE COATING CAME OFF (DISTAL END). HENCE TO RESOLVE THE ISSUE, A NEW DEVICE WAS OPENED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. IT WAS FURTHER CONFIRMED THAT THERE WERE NO DIFFICULTY NOTED WITH PATIENT ANATOMY. PATIENT HAD NO HARDWARE LEADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18276285 ↗
• InjuryNov 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED AND THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. HEPARIN 10,000 UNITS WAS ADMINISTERED. THE TRANSSEPTAL PUNCTURE WAS PERFORMED WITHOUT ANY ISSUES. THE VERSACROSS RADIOFREQUENCY WIRE CROSSED THE SEPTUM, AND THE SEPTUM WAS DILATED WITH THE WATCHMAN SHEATH. THE PHYSICIAN THEN ENCOUNTERED DIFFICULTY IN CROSSING THE SEPTUM WITH THE NON-BSC INTRACARDIAC ECHOCARDIOGRAM (ICE) CATHETER. IT WAS NOTED THAT THE SEPTUM HAD A THICK SUPERIOR LUMBUS. IT WAS NOTED THERE WAS FLUID AROUND THE RIGHT ATRIUM AND VENTRICLE. ECHO STAFF WAS CALLED AND PROTAMINE WAS ORDERED. THE ICE REPRESENTATIVE AND THE PHYSICIAN SUSPECTED THE ICE CATHETER WAS GOING THROUGH A SUPERIOR LIMBUS TUNNEL WHICH CAUSED PERICARDIAL EFFUSION (PE). THE PATIENT WAS UNDER CONSCIOUS SEDATION AND REMAINED STABLE. THE PROCEDURE WAS CANCELLED AND A PERICARDIOCENTESIS WAS PERFORMED. TRACE PE WAS NOTED VIA TRANSTHORACIC ECHOCARDIOGRAM AND FLUID WAS REMOVED. CT SURGERY WAS CONSULTED. A BLOOD TRANSFUSION WAS INITIATED AND LATER DECISION WAS MADE TO SEND THE PATIENT TO SURGERY. POST-SURGERY TH

  Patient problems: Pericardial Effusion

  MAUDE report 18202736 ↗
• InjuryNov 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED AND THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. HEPARIN 10,000 UNITS WAS ADMINISTERED. THE TRANSSEPTAL PUNCTURE WAS PERFORMED WITHOUT ANY ISSUES. THE VERSACROSS RADIOFREQUENCY WIRE CROSSED THE SEPTUM, AND THE SEPTUM WAS DILATED WITH THE WATCHMAN SHEATH. THE PHYSICIAN THEN ENCOUNTERED DIFFICULTY IN CROSSING THE SEPTUM WITH THE NON-BSC INTRACARDIAC ECHOCARDIOGRAM (ICE) CATHETER. IT WAS NOTED THAT THE SEPTUM HAD A THICK SUPERIOR LUMBUS. IT WAS NOTED THERE WAS FLUID AROUND THE RIGHT ATRIUM AND VENTRICLE. ECHO STAFF WAS CALLED AND PROTAMINE WAS ORDERED. THE ICE REPRESENTATIVE AND THE PHYSICIAN SUSPECTED THE ICE CATHETER WAS GOING THROUGH A SUPERIOR LIMBUS TUNNEL WHICH CAUSED PERICARDIAL EFFUSION (PE). THE PATIENT WAS UNDER CONSCIOUS SEDATION AND REMAINED STABLE. THE PROCEDURE WAS CANCELLED AND A PERICARDIOCENTESIS WAS PERFORMED. TRACE PE WAS NOTED VIA TRANSTHORACIC ECHOCARDIOGRAM AND FLUID WAS REMOVED. CT SURGERY WAS CONSULTED. A BLOOD TRANSFUSION WAS INITIATED AND LATER DECISION WAS MADE TO SEND THE PATIENT TO SURGERY. POST-SURGERY TH

  Patient problems: Pericardial Effusion

  MAUDE report 18202733 ↗
• MalfunctionMay 22, 2023Thermal Decomposition of Device; Failure to Advance; Thermal Decomposition of Device; Failure to Advance

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE, THE RADIO FREQUENCY (RF) WIRE COULD NOT PERFORM TRANSSEPTAL PUNCTURE AS IT DID NOT CROSS THE SEPTUM. THE RF DELIVERY WAS ATTEMPTED AROUND FIVE TIMES BUT CROSSING THE SEPTUM COULD NOT BE PERFORMED. TO TROUBLESHOOT, THE STAFF CONFIRMED THAT THE APPROPRIATE AMOUNT OF THE RF WIRE WAS EXPOSED OUTSIDE THE DILATOR. NO DIFFICULT ANATOMY WAS NOTED DURING THE CASE WHICH MAY HAVE CONTRIBUTED TO THE ISSUE. THERE WERE NO ERRORS DISPLAYED ON THE RF GENERATOR, BUT THE WIRE WASN'T ABLE TO CROSS THE SEPTUM DESPITE APPROPRIATE WIRE EXPOSURE. UPON REMOVAL OF THE RF WIRE THE TIP OF THE WIRE WAS BLACK, NO DAMAGE WAS NOTED PRIOR TO THE PROCEDURE. GENTLE FORWARD PRESSURE WAS APPLIED DURING THE DURATION OF THE RADIO FREQUENCY APPLICATION. A NEW VERSACROSS ACCESS SOLUTION KIT WAS OPENED THE RADIO FREQUENCY WIRE WORKED FINE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16978223 ↗