VersaCross RF WireRecalls & reported problems across all models

We found 2 models of VersaCross RF Wire by Baylis Médicale Cie Inc in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Feb 4, 2021 and Jan 28, 2025 — classified as 15 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (2 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 VersaCross RF Wire problems

VersaCross RF Wire models

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

• VersaCross RF Wire VXW-35-230-P

  Catheter, Septostomy
  15 reports
• VersaCross RF Wire VXW-35-180-P

  Catheter, Septostomy
  7 reports

Recent VersaCross RF Wire adverse event reports

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

• MalfunctionJan 28, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT BMC RF WIRE WAS SELECTED FOR PULSE FIELD ABLATION. DURING THE PROCEDURE, RADIO FREQUENCY WAS APPLIED ONCE, AND THEN, WHEN PERFORMING AGAIN THE TRANSEPTAL PUNCTURE, SINCE THE PHYSICIAN WAS NOT SURE ABOUT THE POSITION, THE RADIO FREQUENCY DID NOT WORK. THUS, THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURN FOR ANALYSIS. NO OTHER ISSUES WERE REPORTED. THE DEVICE HAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21256482 ↗
• MalfunctionMay 1, 2024Difficult to Remove; Material Deformation; Physical Resistance/Sticking; Difficult to Remove; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A TRANSSEPTAL PUNCTURE PROCEDURE, A VERSACROSS RF WIRE WAS SELECTED FOR USE. THE PHYSICIAN TRIED TO INSERT THE VERSACROSS RF WIRE DIRECTLY THROUGH THE NON-BOSTON SCIENTIFIC SYRINGE NEEDLE CAUSING BENDING OF THE WIRE TIP. THUS, THE DEVICE WAS REPLACED, AND THE ISSUE WAS RESOLVED. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS STILL ON HOSPITAL FACILITIES AND THE PRODUCT WILL NOT RETURN FOR ANALYSIS. IT HAS BEEN FURTHER MENTIONED THAT WHEN THE VERSACROSS RF WIRE WAS INSERTED DIRECTLY INTO THE NON-BOSTON SCIENTIFIC NEEDLE UTILIZED FOR FEMORAL ACCESS, IT BECAME STUCK JUST AFTER THE TIP OF THE NON-BOSTON SCIENTIFIC NEEDLE. THE PHYSICIAN ATTEMPTED TO PULL IT OUT, BUT WAS UNABLE TO DO SO AND THEREFORE REMOVED THE VERSACROSS RF WIRE AND NEEDLE ALTOGETHER. OUTSIDE THE PATIENT'S BODY, THE PHYSICIAN WAS ABLE TO RETRACT THE VERSACROSS RF WIRE FROM THE NEEDLE, AND THAT'S WHEN THE KINK WAS NOTED. NO OTHER ISSUES WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226449 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERICARDIAL EFFUSION WAS NOTED THAT LEAD TO A PROCEDURAL ABORTION WHERE VERSACROSS LARGE ACCESS TRANSSEPTAL DILATOR, VERSACROSS RF WIRE AND AGILIS SHEATH (NON-BAYLIS DEVICE) WERE USED. TRANSSEPTAL WAS UNSUCCESSFUL USING THE VERSCROSS LARGE ACCESS TRANSSEPTAL DILATOR AND VERSACROSS RF WIRE. BOTH TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND ICE IMAGING WERE USED BUT THE PHYSICIAN WAS UNABLE TO VIEW THE DILATOR TENT THE SEPTUM.. THE PHYSICIAN DECIDED TO USE THE AGILIS SHEATH WITH THE VERSACROSS RF WIRE. THE PHYSICIAN HAD DIFFICULTY VIEWING THE LOCATION OF THE CATHETER ON THE BICAVAL VIEW. TRANSSEPTAL WAS ATTEMPTED THREE TIMES HOWEVER, THE PHYSICIAN WAS UNABLE TO ADVANCE THE DEVICES INTO THE SEPTUM. AN EFFUSION WAS NOTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND ON FLUOROSCOPY. THE PATIENT'S BLOOD PRESSURE DROPPED, AND A PERICARDIAL TAP WAS PERFORMED STABILIZING THE PATIENTS' BLOOD PRESSURE. BLOOD WAS RE-INFUSED INTO THE PATIENT. ONCE THE FLUID COLLECTION STOPPED, THE PHYSICIAN DECIDED TO REMOVE THE DRAIN. PATIENT WAS EXTUBATED, DRESSING WAS APPLIED TO SUBXYPHOID AREA AND THE PROCEDURE WAS ABORTED. THE PATIENT WAS SENT TO RECOVERY AREA. AS A BAYLIS MEDICAL DEVICE WAS REPORTED TO B

  Patient problems: Pericardial Effusion

  MAUDE report 16154491 ↗
• MalfunctionJan 6, 2023Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A PROCEDURE, THE VERSACROSS RF WIRE USED DURING TRANSSEPTAL SHEARED OFF. THERE IS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16118767 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CASE OF AORTIC PERFORATION LEADING TO PROCEDURAL ABORTION WAS REPORTED WHERE THE VERSACROSS TRANSSEPTAL SHEATH AND VERSACROSS RF WIRE WERE USED FOR TRANSSEPTAL PUNCTURE. TRANSSEPTAL PUNCTURE WAS COMPLETED SUCCESSFULLY TWICE. HOWEVER, THE LOCATION OF THE PUNCTURE WAS NOT OPTIMAL FOR IMPLANTATION OF THE WATCHMAN DEVICE. ON THE THIRD ATTEMPT, THE VERSACROSS RF WIRE AND VERSACROSS TRANSSPETAL SHEATH CROSSED THE SEPTUM SUCCESSFULLY AND ADVANCED INTO THE LEFT ATRIUM WHERE A PERFORATION OCCURRED. AN EFFUSION WAS ALSO NOTED USING TRANSESOPHAGEAL ECHOCARDIOGRAPHY AND WAS TREATED WITH PERICARDIOCENTESIS. THE PHYSICIAN CONSULTED SURGERY AND THE PROCEDURE WAS ABORTED. AS A BAYLIS MEDICAL DEVICE WAS REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT. A SEPARATE PROBLEM REPORT HAS BEEN SUBMITTED FOR THE VERSACROSS TRANSSEPTAL SHEATH WITH THE REPORT NUMBER 3019751610-2022-00030.

  Patient problems: Perforation

  MAUDE report 15337611 ↗
• InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CASE OF AN AORTIC PERFORATION LEADING TO A PROCEDURAL ABORTION DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WAS REPORTED WHERE THE BAYLIS MEDICAL VERSACROSS RF WIRE (RF WIRE) WAS USED FOR THE INITIAL TRANSSEPTAL PUNCTURE OF THE PROCEDURE. THE PATIENT'S ATRIAL SEPTUM WAS NOTED TO BE HYPER ELASTIC ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE RF WIRE WAS POSITIONED ON THE SEPTUM. THE RF WIRE CROSSED THE SEPTUM AND WAS NOTED TO BE ADVANCED IN THE AORTA ON TEE. THE RF WIRE WAS RETRACTED INTO THE RIGHT ATRIUM. A PIGTAIL CATHETER WAS INTRODUCED INTO THE AORTA. CONTRAST WAS ADMINISTERED, AND A PUNCTURE TO THE AORTA WAS CONFIRMED. THE LAAC PROCEDURE WAS ABORTED. THE PATIENT WAS STABLE AND UNDERWENT COMPUTED TOMOGRAPHY IMAGING. MINIMAL PERICARDIAL EFFUSION WAS NOTED. THE AORTIC PERFORATION WAS REPORTED TO HEAL AS THE PATIENT CONTINUED TO REMAIN IN STABLE CONDITION 12 HOURS LATER. AS A BAYLIS MEDICAL DEVICE WAS REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT.

  Patient problems: Perforation

  MAUDE report 14957870 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CASE OF PERICARDIAL EFFUSION REQUIRING INTERVENTION WAS REPORTED DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, WHERE THE BAYLIS MEDICAL, VERSACROSS STEERABLE SHEATH (VST), VERSACROSS TRANSSEPTAL SHEATH (VXS) AND VERSACROSS RF WIRE (VXW) WERE USED FOR THE INITIAL TRANSSEPTAL PUNCTURE. THE VST WAS WIRED WITH THE VXW AND INSERTED IN THE PATIENT. DUE TO COMPLEX PATIENT ANATOMY, THE PHYSICIAN EXPERIENCED DIFFICULTY MANEUVERING THE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) PROBE TO VISUALIZE TENTING OF THE SEPTUM. THE PHYSICIAN ATTEMPTED TO REWIRE AND RE-POSITION THE VST ON THE SEPTUM SIX MORE TIMES. TENTING OF THE SEPTUM COULD NOT BE CONFIRMED DUE TO POOR IMAGING AND THE VST WAS EXCHANGED WITH THE VXS. THE VXS WAS SHAPED, WIRED AND INSERTED FOR POSITIONING. WITH NO CLEAR IMAGING OF THE SEPTUM OR THE VXS, THE PHYSICIAN REQUESTED ANOTHER SIZED SHEATH. BEFORE THE SHEATH COULD BE EXCHANGED, THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP. A PERFORATION LEADING TO PERICARDIAL EFFUSION WAS NOTED IN THE RIGHT ATRIAL APPENDAGE. THE LAAC PROCEDURE WAS ABORTED. PERICARDIOCENTESIS WAS PERFORMED. CARDIOTHORACIC SURGERY WAS CONSULTED. MORE FLUID WAS REMOVED AND THE PATIENT WAS STABILIZED. THERE

  Patient problems: Pericardial Effusion

  MAUDE report 14597532 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CASE OF A BLOOD CLOT FORMATION REQUIRING INTERVENTION WAS REPORTED DURING A CRYOABLATION PROCEDURE WHERE THE BAYLIS MEDICAL VERSACROSS RF WIRE (RF WIRE), AND VERSACROSS LARGE ACCESS TRANSSEPTAL DILATOR WERE USED FOR INITIAL TRANSSEPTAL PUNCTURE. TRANSSPETAL PUNCTURE WAS SUCCESSFULLY COMPLETED AND THE VERSACROSS LARGE ACCESS DILATOR WAS REMOVED FROM THE PATIENT. THE RF WIRE REMAINED IN THE LEFT ATRIUM OF THE PATIENT MAINTAINING TRANSSEPTAL ACCESS. AFTER ABOUT 10 MINUTES POST TRANSSEPTAL, HEPARIN WAS ADMINISTERED. WHILE ADVANCING THE CRYOABLATION SHEATH INTO THE LEFT ATRIUM OVER THE RF WIRE USING AN INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER, A BLOOD CLOT ON THE RF WIRE WAS NOTED. AN INTERVENTIONAL CARDIOLOGIST WAS CONSULTED. DURING DEPLOYMENT OF A SENTINEL CEREBRAL PROTECTION SYSTEM (BOSTON SCIENTIFIC), THE RF WIRE WAS INADVERTENTLY PULLED BACK DISPLACING THE BLOOD CLOT FROM THE RF WIRE. VASCULAR SURGERY AND NEURO-INTERVENTION WERE CONSULTED. THE PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY (CT) SCAN. CT RESULTS WERE NORMAL. THERE IS NO REASONABLE EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICES CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS BAYLIS MEDICAL DEVICES

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14596407 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CASE OF PERICARDIAL EFFUSION REQUIRING INTERVENTION WAS REPORTED DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WHERE THE VERSACROSS LARGE ACCESS TRANSSEPTAL DILATOR AND VERSACROSS RF WIRE WERE USED AMONG OTHER DEVICES INCLUDING THE WATCHMAN DEVICES (BOSTON SCIENTIFIC CORPORATION) THE PHYSICIAN EXPERIENCED DIFFICULTY VISUALIZING THE POSITIONING OF THE DEVICES DUE TO POOR TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING. THE VERSACROSS DEVICES WERE POSITIONED ON THE SEPTUM AND TRANSSEPTAL PUNCTURE WAS SUCCESSFULLY COMPLETED. THE VERSACROSS RF WIRE, VERSACROSS LARGE ACCESS TRANSSEPTAL DILATOR AND WATCHMAN SHEATH WERE ADVANCED INTO THE LEFT ATRIUM. UNABLE TO VISUALIZE THE DEVICES USING TEE, THE PHYSICIAN USED CONTRAST FOR FLUOROSCOPIC VISUALIZATION. DARKENING IN THE PERICARDIAL SPACE WAS NOTED AND A PERICARDIAL EFFUSION WAS NOTED ON ECHO. THE LAAC PROCEDURE WAS ABORTED, ALL DEVICES WERE REMOVED AND PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT REMAINED STABLE THROUGHOUT PROCEDURE AND WAS KEPT FOR OVERNIGHT OBSERVATION. THERE IS NO REASONABLE EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICES CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS BAYLIS MEDICAL DEVICES W

  Patient problems: Pericardial Effusion

  MAUDE report 14278755 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CASE OF PERICARDIAL EFFUSION REQUIRING INTERVENTION WAS REPORTED DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WHERE THE VERSACROSS LARGE ACCESS TRANSSEPTAL DILATOR AND VERSACROSS RF WIRE WERE USED AMONG OTHER DEVICES INCLUDING THE WATCHMAN DEVICES (BOSTON SCIENTIFIC CORPORATION) THE PHYSICIAN EXPERIENCED DIFFICULTY VISUALIZING THE POSITIONING OF THE DEVICES DUE TO POOR TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING. THE VERSACROSS DEVICES WERE POSITIONED ON THE SEPTUM AND TRANSSEPTAL PUNCTURE WAS SUCCESSFULLY COMPLETED. THE VERSACROSS RF WIRE, VERSACROSS LARGE ACCESS TRANSSEPTAL DILATOR AND WATCHMAN SHEATH WERE ADVANCED INTO THE LEFT ATRIUM. UNABLE TO VISUALIZE THE DEVICES USING TEE, THE PHYSICIAN USED CONTRAST FOR FLUOROSCOPIC VISUALIZATION. DARKENING IN THE PERICARDIAL SPACE WAS NOTED AND A PERICARDIAL EFFUSION WAS NOTED ON ECHO. THE LAAC PROCEDURE WAS ABORTED, ALL DEVICES WERE REMOVED AND PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT REMAINED STABLE THROUGHOUT PROCEDURE AND WAS KEPT FOR OVERNIGHT OBSERVATION. THERE IS NO REASONABLE EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICES CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS BAYLIS MEDICAL DEVICES W

  Patient problems: Pericardial Effusion

  MAUDE report 14278754 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A LEFT ATRIAL APPENDAGE CLOUSE (LAAC) PROCEDURE, THE VERSACROSS TRANSSEPTAL SHEATH AND VERSACROSS RF WIRE (BAYLIS MEDICAL COMPANY INC.) WERE USED FOR THE INITIAL TRANSSEPTAL PUNCTURE OF THE PROCEDURE WITH NO OBSERVED INITIAL COMPLICATIONS. AFTER TRANSSEPTAL PUNCTURE, THE WATCHMAN FLX (BOSTON SCIENTIFIC CORP.) DEVICES WERE USED TO COMPLETE THE LAAC PROCEDURE. UPON POST-PROCEDURE VERIFICATION, THE PATIENT WAS NOTED TO HAVE A HEMOTHORAX. THE HEMOTHORAX WAS DRAINED AND THE PATIENT WAS KEPT FOR OBSERVATION. FOLLOW-UP REQUESTS REVELED THAT THE PATIENT IS DOING WELL AND IS EXPECTED TO RECOVER. AS THE HEMOTHROAX WAS IDENTIFIED AFTER COMPLETION OF THE CLOSURE PROCEDURE, THERE IS NO OBJECTIVE EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICES CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS THE BAYLIS DEVICES WERE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT. A SEPARATE PROBLEM REPORT HAS BEEN SUBMITTED FOR THE VERSACROSS TRANSSEPTAL SHEATH WITH REPORT NUMBER 9710452-2022-00024.

  Patient problems: Hemothorax

  MAUDE report 14249848 ↗
• MalfunctionApr 13, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  A 20-MINUTE PROCEDURAL DELAY WAS REPORTED DUE TO KNOTTING OF THE VERSACROSS RF WIRE (RF WIRE) WHILE ATTEMPTING TO PULL THE WIRE INTO THE VERSACROSS TRANSSEPTAL SHEATH FOR THE DROP DOWN OF THE TRANSSEPTAL PUNCTURE WORKFLOW. THE VERSACROSS TRANSSEPTAL SHEATH BECAME KINKED IN THE PROCESS. THE PROCEDURE WAS ABLE TO CONTINUE AFTER A NEW VERSACROSS RF WIRE AND VERSACROSS TRANSSEPTAL SHEATH WERE USED TO PERFORM A SUCCESSFUL TRANSSEPTAL PUNCTURE. WHILE THERE WAS NO PATIENT INJURY REPORTED, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE PROCEDURAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14106901 ↗
• InjuryMar 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CASE OF AORTIC PERFORATION LEADING TO A PROCEDURAL ABORTION WAS REPORTED DURING A CRYOABLATION ATRIAL FIBRILLATION PROCEDURE, WHERE THE VERSACROSS RF WIRE WAS USED TO ATTEMPT TRANSSEPTAL PUNCTURE. DUE TO COMPLEX PATIENT ANATOMY, THE PHYSICIAN ATTEMPTED A MORE SUPERIOR TRANSSEPTAL APPROACH, AND WHILE ADVANCING THE RF WIRE, THE PHYSICIAN NOTICED AN ARTIFACT AND MANEUVERED AN ICE CATHETER TO INVESTIGATE. UPON INVESTIGATION, THE RF WIRE WAS OBSERVED TO BE IN THE AORTA. THE PHYSICIAN IMMEDIATELY REQUESTED A SURGICAL CONSULT, AFTER WHICH THE RF WIRE WAS REMOVED FROM THE AORTA WITHOUT FURTHER COMPLICATIONS. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS ADMITTED TO THE ICU FOR OVERNIGHT OBSERVATION WHERE THEY WERE LATER SENT HOME.

  Patient problems: Perforation

  MAUDE report 13739460 ↗
• MalfunctionFeb 28, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  A 30-MINUTE PROCEDURAL DELAY WAS REPORTED DUE TO KINKING OF THE VERSACROSS RF WIRE (RF WIRE) AFTER MULTIPLE ATTEMPTS WERE MADE TO CROSS A THICK CALCIFIED SEPTUM. FOLLOWING THIS ISSUE, THE RF WIRE WAS REMOVED FROM THE PATIENT TOGETHER WITH THE VERSACROSS SHEATH/DILATOR ASSEMBLY. UPON INSPECTION OF THE DEVICES, DAMAGE TO THE RF WIRE WAS NOTED. THE PROCEDURE WAS ABLE TO CONTINUE AFTER A NEW VERSACROSS RF WIRE WAS USED TO PERFORM A SUCCESSFUL TRANSSEPTAL PUNCTURE. WHILE THERE WAS NO PATIENT INJURY REPORTED, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE PROCEDURAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13624931 ↗
• InjuryNov 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE VERSACROSS RF WIRE AND VERSACROSS TRANSSEPTAL SHEATH WERE USED DURING A MITRACLIP PROCEDURE. UPON TRANSSEPTAL ACCESS, A BLOOD CLOT WAS OBSERVED ON THE DEVICES ON THE LEFT SIDE OF THE HEART. HEPARIN WAS ADMINISTERED AND THE VERSACROSS RF WIRE WAS RETRACTED WHILE ASPIRATING. THE CLOT WAS CAPTURED AND NO ADVERSE REACTIONS OCCURRED. THERE IS NO EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICES CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS A BAYLIS MEDICAL DEVICES WERE REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT. A SEPARATE PROBLEM REPORT HAS BEEN SUBMITTED FOR THE VERSACROSS TRANSSEPTAL SHEATH WITH THE REPORT NUMBER 9710452-2021-00051.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12804159 ↗

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