PREFACE 301803MRecalls & reported problems

Summary

The FDA's MAUDE database contains 152 adverse event reports that list this exact device (DI 10846835000047), received between Feb 26, 2018 and Aug 13, 2026 — classified as 1 death, 19 injuries, 132 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (50 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 152 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50241523 ↗
• MalfunctionJun 18, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PERSISTENT ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PREFACE SHEATH AND THE HEMOSTATIC VALVE BROKE. THE HEMOSTATIC VALVE OF THE SHEATH BROKE WHEN REMOVING THE OCTARAY CATHETER. NO SIGNIFICANT BLOOD LOSS WAS OBSERVED AND THE HEMOSTATIC VALVE DID NOT DISLODGE INSIDE THE HUB. IT WAS UNCLEAR IF THE VALVE DISLODGED OUTSIDE OF THE HUB. THE BRIM CAP AND HUB DID NOT DETACH FROM THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25546056 ↗
• MalfunctionJun 17, 2026Material Perforation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION CARDIAC ABLATION PROCEDURE WITH A PREFACE SHEATH AND OBSERVED A RUPTURE (PERFORATION) ON THE DILATOR. PREFACE INTRODUCER WAS OPENED DURING THE PROCEDURE. THE INTERATRIAL SEPTUM WAS ADVANCED AND APPROACHED TO PERFORM A TRANSSEPTAL PUNCTURE BUT THERE WAS EVIDENCE OF LOSS OF THE CURVE DURING FLUOROSCOPY. THE INTRODUCER WAS REMOVED AND RUPTURE AND PASSAGE OF THE DILATOR WAS EVIDENCED BY THE RUPTURE, WHICH IS WHY IT WAS NECESSARY TO REPLACE IT WITH ANOTHER ONE. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. ADDITIONAL INFORMATION WAS RECEIVED. RESISTANCE OCCURRED IN THE HEART BEFORE PERFORMING THE TRANSSEPTAL PUNCTURE. AT NO TIME WAS THE INTERNAL SHEATH MECHANISM EXPOSED TO THE PATIENT; RESISTANCE WAS ENCOUNTERED AND IT WAS WITHDRAWN IMMEDIATELY. THE SOFT TIP BUCKLED. IT WAS NOT OBSERVED THAT THE SHAFT WAS ROUGH; THE INTRODUCER WAS FLUSHED NORMALLY WITH HEPARINIZED SOLUTION, AND THE TRANSSEPTAL NEEDLE ADVANCED SMOOTHLY WITHOUT ISSUE. IT WAS NOT OBSERVED TO BE OUTSIDE THE INSTRUCTIONS FOR USE (IFU) SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25536079 ↗
• InjuryJun 10, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. DURING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE. ECHOCARDIOGRAPHY REVEALED A PERICARDIAL EFFUSION CAUSING CARDIAC TAMPONADE. THE BLOOD WAS DRAINED AND THE PATIENT WAS STABILIZED. THE PATIENT WENT TO THE ICU (INTENSIVE CARE UNIT) AND WAS STABLE FOR TWO HOURS AFTER THE PROCEDURE. THE PHYSICIAN SUSPECTED THAT IT MAY HAVE OCCURRED DURING TRANSSEPTAL PUNCTURE.

  Patient problems: Cardiac Tamponade

  MAUDE report 25462738 ↗
• MalfunctionMay 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PREFACE SHEATH AND WHEN OPENING THE DEVICE THE DOCTOR NOTICED THAT AIR LEAKED FROM THE HEMOSTATIC VALVE. THIS DEVICE WAS NEVER USED ON THE PATIENT. THE PHYSICIAN DECIDED TO IMMEDIATELY CHANGE TO A NEW SHEATH AND CONTINUE THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25102498 ↗
• InjuryApr 20, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION WITH A PREFACE SHEATH AND THE PATIENT EXPERIENCED A THROMBOSIS. A TRANSSEPTAL PUNCTURE WAS PERFORMED. HOWEVER, BECAUSE THE PATIENT WAS VERY TALL, THE PREFACE SHEATH DID NOT REACH PROPERLY, SO THE DOCTOR COULD NOT SECURE IT IN THE SEPTUM TO SUBSEQUENTLY ADVANCE THE CATHETER. AFTER SEVERAL ATTEMPTS (AND NO HEPARIN WAS GIVEN), A THROMBUS FORMED NEAR THE FOSSA IN THE LEFT ATRIUM. THE PROCEDURE WAS CANCELLED IMMEDIATELY. THE THROMBUS DISLODGED. THE PATIENT WOKE UP, AND AFTER A NEUROLOGICAL EXAMINATION BY THE DOCTORS THERE WERE NO CONSEQUENCES AT THAT TIME.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24927760 ↗
• MalfunctionMar 25, 2026Backflow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A PREFACE SHEATH. AIR WAS CONTINUOUSLY DRAWN IN THROUGH THE SIDE PORT OF THE PREFACE SHEATH. TIMING WAS WHEN A CATHETER WAS REMOVED FROM THE PREFACE SHEATH FOR SWITCHING. NO PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691316 ↗
• InjuryFeb 5, 2026Patient Device Interaction Problem

  A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE, WHILE GOING TRANSSEPTAL WITH A PREFACE SHEATH, THE PATIENT EXPERIENCED TWO TAMPONADES FOLLOWING A HOLE THAT WAS CREATED. TAMPONADE WERE DRAINED, FOLLOWED BY OPEN THE CHEST SURGICAL INTERVENTION TO TREAT CARDIAC PERFORATION (HOLE). DURING THE REPEAT ABLATION PROCEDURE THE PATIENT EXPERIENCED TWO TAMPONADES FOLLOWING A HOLE THAT WAS CREATED DURING THE TRANSEPTAL PUNCTURE PROCEDURE THAT PRECEDED THE ABLATION STAGE. THE FIRST TAMPONADE WAS DRAINED, WHICH ALLOWED THE ABLATION PROCEDURE TO CONTINUE, AND FOLLOWING THE SECOND TAMPONADE IT WAS DECIDED TO HAVE A SURGICAL INTERVENTION TO OPEN THE CHEST TO TREAT THE TAMPONADE. THE TAMPONADE WAS TREATED SUCCESSFULLY AND PATIENT WAS RECOVERING. ACCORDING TO THE REPORT, THE TRANSEPTAL PUNCTURE WAS PERFORMED USING A BRK NEEDLE THAT WAS PASSED THROUGH THE AFORESAID INITIAL SHEATH OF THE PREFACE. THE BRK NEEDLE AND A SAFESEPT WIRE WAS ADVANCED TO CROSS THE INTERATRIAL SEPTUM FROM THE RIGHT ATRIUM TO THE LEFT ATRIUM. ACCORDING TO THE ELECTROPHYSIOLOGIST, DURING THE PUNCTURE, THE SAFESEPT WIRE THAT LED THE BRK NEEDLE (WHICH IN TURN LED THE AFORESAID BIOSENSE PREFACE SHEATH

  Patient problems: Cardiac Perforation

  MAUDE report 24274166 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PREFACE SHEATH AND THE DILATOR WAS BROKEN. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977771 ↗
• MalfunctionDec 31, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PREFACE SHEATH AND ¿THE BOTTOM PART OF PREFACE BROKE.¿ IT WAS REPORTED AIR COULD HAVE GOT IN IF PHYSICIAN DID NOT PRESS THUMB ON IT. NO CONSEQUENCE FOR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23933159 ↗
• MalfunctionDec 9, 2025Material Perforation; Material Perforation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PREFACE SHEATH AND WHEN INSERTING THE PREFACE IN THE RIGHT ATRIUM THE MEDICAL TEAM LOOKED THROUGH THE FLUOROSCOPY AND REALIZED THE SHEATH HAD BEEN PUNCTURED BY THE NEEDLE WHERE IT SHOULDN'T HAVE BEEN. NO FURTHER DETAILS WERE PROVIDED REGARDING TROUBLESHOOTING OR COMPLETION OF THE PROCEDURE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760197 ↗
• MalfunctionNov 3, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PREFACE SHEATH. IN THIS CASE, THE PHYSICIAN USED THE PREFACE SHEATH SINCE THE FEMORAL VEIN PUNCTURE, TO DO THE CTI ABLATION, AND AFTER THE PATIENT HAD A LEFT SIDE TACHYCARDIA. THEREFORE, THE DOCTOR NEEDED TO DO A SEPTAL PUNCTURE WITH THE PREFACE SHEATH FOR THE LEFT SIDE TACHYCARDIA. HOWEVER, DURING THE SEPTAL PUNCTURE, THE PHYSICIAN COULD NOT PUSH THE SHEATH ALONG WITH THE DILATOR BUT ONLY DILATOR COULD THROUGH TO THE LEFT ATRIUM (LA). THEREFORE, THEY DECIDED TO CHANGE TO A NEW SHEATH (PREFACE) AND IT COULD GO THROUGH. AFTER, SAW THE EDGE AT THE END OF THE SHEATH WAS UNEVEN AND WRINKLED. THE PROCEDURE WAS NOT DELAYED DUE TO THE REPORTED ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23458697 ↗
• MalfunctionOct 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH PREFACE SHEATH AND THE CAP FELL OFF ISSUE WAS OBSERVED. EVERY TIME THE PHYSICIAN PULLED THE CATHETER OUT OF THE PREFACE SHEATH THE CAP/VENTIL FELL OFF AND HE HAD TO REATTACH IT. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. THE SECTION WHERE THE ISSUE WAS OBSERVED WAS THE WHITE ROUND CAP THAT IS ATTACHED AT THE END OF THE SHEATH WHERE THE PHYSICIAN PUTS THE CATHETER THROUGH. IT IS A CAP THAT CAN BE SEPARATED FROM THE SHEATH BUT WAS ALWAYS SEPARATING FROM THE SHEATH WHEN THE CATHETER WAS PULLED. THIS CAP SHOULD BE ABLE TO STAY IN PLACE WHEN THE CATHETER IS PULLED. THE SHEATH WAS BEING USED ON THE PATIENT. NO AIR ENTERED THE PATIENT¿S BODY. NO PATIENT CONSEQUENCE. IT DID NOT REQUIRE TREATMENT. NO BLOOD RETURN WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23319830 ↗
• MalfunctionAug 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE AND WHEN PASSING THE NEEDLE THROUGH THE SHEATH DILATOR AS A TEST BEFORE PASSING THROUGH THE PATIENT'S ACCESS, IT WAS OBSERVED THAT THERE WERE RESIDUES OF THE DILATOR AT THE TIP OF THE NEEDLE WHEN REMOVING IT. AFTER THE EXCHANGE OF THE SHEATH AND NEEDLE, THERE WERE NO MORE PROBLEMS, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AT THE END OF THE PROCEDURE, THE PRODUCTS WERE DISCARDED BY THE CUSTOMER. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22819416 ↗
• MalfunctionJun 26, 2025Material Perforation; Material Perforation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PREFACE AND A HOLE NEAR THE TIP OF THE DILATOR WAS NOTICED. IT WAS REPORTED THAT AFTER THE PREFACE SHEATH WAS REMOVED FROM THE BODY, A HOLE TOWARDS THE DISTAL TIP OF THE PREFACE SHEATH'S DILATOR WAS NOTICED. THE PREFACE SHEATH WAS REPLACED AND THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22343001 ↗
• MalfunctionMay 19, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PREFACE AND WHILE SETTING UP FOR THE PROCEDURE, IT WAS NOTICED THAT THE TWO PRODUCT BOXES FOR THE PREFACE SHEATHS WERE DAMAGED. IT APPEARED AS IF THE "BOXES HAD BEEN LEFT OUT IN THE RAIN," AS WATER HAD SEEPED THROUGH THE BOX AND INTO THE PRODUCT PACKAGING. THERE WAS WATER INSIDE THE INNER BAG AND THE INNER MATERIAL WAS SOAKED. IT WAS ALSO REPORTED THAT THE POUCH SEAL WAS DAMAGED IN BOTH OF THE PRODUCT PACKAGES FOR THE PREFACE SHEATHS, COMPROMISING THE STERILITY. THE PROCEDURE CONTINUED UTILIZING A DIFFERENT PREFACE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22049153 ↗
• MalfunctionMay 19, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PREFACE AND WHILE SETTING UP FOR THE PROCEDURE, IT WAS NOTICED THAT THE TWO PRODUCT BOXES FOR THE PREFACE SHEATHS WERE DAMAGED. IT APPEARED AS IF THE "BOXES HAD BEEN LEFT OUT IN THE RAIN," AS WATER HAD SEEPED THROUGH THE BOX AND INTO THE PRODUCT PACKAGING. THERE WAS WATER INSIDE THE INNER BAG AND THE INNER MATERIAL WAS SOAKED. IT WAS ALSO REPORTED THAT THE POUCH SEAL WAS DAMAGED IN BOTH OF THE PRODUCT PACKAGES FOR THE PREFACE SHEATHS, COMPROMISING THE STERILITY. THE PROCEDURE CONTINUED UTILIZING A DIFFERENT PREFACE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22049151 ↗
• MalfunctionMar 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PAROXYSMAL ABLATION PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE AND DURING THE STERILE PROCESSING OF THE DEVICE A 'PEELED TIP' WAS IDENTIFIED. NO FURTHER DETAILS WERE PROVIDED REGARDING TROUBLESHOOTING OF THE DEVICE OR COMPLETION OF THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21689920 ↗
• MalfunctionJan 16, 2025Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE AND THERE WAS A BROKEN VALVE IDENTIFIED. THERE WERE NO FURTHER DETAILS REGARDING HOW THE DAMAGE OCCURRED OR TROUBLESHOOTING FOR IT. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21173364 ↗
• MalfunctionJan 14, 2025Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH PREFACE SHEATH AND THE VALVE LEAKING AND SIDE PORT LEAKING ISSUES WERE OBSERVED. THE VALVE ON THE PREFACE SHEATH WAS LEAKING AND THERE WAS BLEED BACK COMING FROM THE SHEATH. THEY EXCHANGED THE PREFACE SHEATH AND THE ISSUE WAS RESOLVED AND THE CASE WAS CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. PHYSICIAN STATED THAT THE BLOOD WAS LEAKING BACK OUT OF THE OPENING FOR THE CATHETER INSERTION AS WELL AS SIDE PORT. UNKNOWN IF THE HEMOSTATIC VALVE DISLODGED. UNKNOWN IF THE BRIM CAP/HUB BECAME DETACHED FROM THE SHEATH. THE SHEATH WAS BEING USED ON THE PATIENT, BUT IT WAS EXCHANGED RIGHT AWAY AFTER NOTICING THE LEAKAGE. IT WAS USED IN THE PATIENT UNDER APPROXIMATELY 10 MINUTES. AIR DID NOT ENTER THE PATIENT¿S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21146898 ↗
• MalfunctionDec 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PREFACE SHEATH AND THE VALVE WAS RELEASED FROM THE SHEATH. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GAIN CLARIFICATION AND ADDITIONAL INFORMATION ABOUT THIS EVENT WITH NO RESPONSE. SHOULD ANY NEW INFORMATION BE OBTAINED IT WILL BE ASSESSED AND PROCESSED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20921059 ↗
• MalfunctionNov 19, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PREFACE SHEATH AND THE TIP LACERATE (TORE) ISSUE WAS OBSERVED. PREFACE TIP LACERATE. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE TIP TORE AS THE PHYSICIAN TRIED TRANSEPTAL AND THE NEEDLE WAS PUSHED THROUGH THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20730661 ↗
• MalfunctionOct 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FASCICULAR VENTRICULAR TACHYCARDIA PROCEDURE WITH A PREFACE AND THE HUB WAS TOTALLY SEPARATED. PREFACE SHEATH HAD A PROBLEM WITH CLOSER VALVE. THE ACTION TAKEN WHEN THE EVENT OCCURRED WAS TO CHANGE THE PREFACE SHEATH. THE PROCEDURE WAS DELAYED BY 5 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 24-SEP-2024. THE HUB WAS THE SECTION WHERE THE ISSUE WAS OBSERVED. IT WAS TOTALLY SEPARATED. UNKNOWN IF THE HEMOSTATIC VALVE DISLODGED INSIDE THE HUB. UNKNOWN IF THE HEMOSTATIC VALVE DISLODGED OUTSIDE THE HUB. THE SHEATH WAS USED ON THE PATIENT. THE PATIENT DID NOT REQUIRE TREATMENT. BLOOD RETURN WAS OBSERVED. THE VOLUME OF BLOOD LOSS WAS UNKNOWN. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE ON 24-SEP-2024 THAT THE HUB WAS TOTALLY SEPARATED AND HAVE REASSESSED THE EVENT AS REPORTABLE. THE AWARENESS DATE FOR THIS RECORD IS 24-SEP-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20427524 ↗
• MalfunctionSep 10, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE AND AFTER THE RIGHT ATRIAL (RA) CAVOTRICUSPID ISTHMUS (CTI) ABLATION, THE HEMOSTATIC VALVE WAS DAMAGED WHEN THE QDOT CATHETER WAS REMOVED, AND REVERSE BLOOD WAS OBSERVED. BLOOD RETURN ONLY AMOUNTED TO 'A FEW DROPS'. THE ISSUE WAS NOTED 4 HOURS AFTER THE START OF THE SHEATH USE, AFTER CTI ABLATION. THE ISSUE WAS RESOLVED BY REPLACING THE PREFACE SHEATH. THE HEMOSTATIC VALVE ITSELF WAS NOT BROKEN. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182829 ↗
• MalfunctionSep 3, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE AND THE SHEATH WOULD NOT ALLOW THE PHYSICIAN TO DRAW BLOOD. WHEN THE SHEATH WAS REPLACED, THE ISSUE WAS RESOLVED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20131375 ↗