PREFACE 301803MSRecalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10846835000030), received between Dec 27, 2018 and Sep 9, 2026 — classified as 2 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Material Separation” (17 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698426 ↗
• MalfunctionJun 4, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PAROXYSMAL ABLATION PROCEDURE WITH A PREFACE SHEATH AND WHEN REMOVING THE DEVICE FROM ITS PACKAGING, THE HEMOSTATIC VALVE 'FELT DIFFERENT FROM USUAL'. THE PHYSICIAN TOUCHED THE SHEATH AND FELT A 'SENSE OF ABNORMALITY', NOTING THAT THE VALVE APPEARED TO BE LOOSELY SECURED TO THE REST OF THE DEVICE. AFTER A PERIOD OF OBSERVATION, THE PHYSICIAN DECIDED THAT THEY WOULD BE UNCOMFORTABLE USING THE DEVICE, AND DECIDED TO REPLACE THE SHEATH. THE PROCEDURE WAS THEN COMPLETED WITH A NEW PREFACE SHEATH 'WITHOUT ANY SENSE OF ABNORMALITY' OR DEFECT. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399130 ↗
• MalfunctionApr 22, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A VIZIGO SHEATH AND WHEN TAKING THE DEVICE OUT OF THE BAG FOR USE, THE HEMOSTATIC VALVE FELT DIFFERENT FROM USUAL, AND THERE WAS A SENSE OF ABNORMALITY (THE VALVE APPEARED TO BE LOOSELY SECURED), CAUSING CONCERN TO THE PHYSICIAN. THE DEVICE WAS NOT USED ON THE PATIENT. THE PHYSICIAN REPLACED THE SHEATH AND CONTINUED THE PROCEDURE. THE CASE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957521 ↗
• MalfunctionMar 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER ABLATION PROCEDURE WITH A PREFACE SHEATH AND THERE WAS BLOOD LEAKAGE IN THE HEMOSTATIC VALVE. IT WAS NOTED THAT THE HUB WAS COMPLETELY DETACHED FROM THE SHEATH. A NEW DEVICE WAS USED TO COMPLETE THE SURGERY AND THERE WAS NO PATIENT INJURY REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24704370 ↗
• MalfunctionMar 26, 2026Material Separation; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PREFACE SHEATH AND THE HEMOSTATIC VALVE HAD "COLLAPSED". THIS WAS NOTED WHEN THE PACKAGING WAS OPENED. THE PROCEDURE ONLY COMMENCED ONCE A REPLACEMENT SHEATH WAS OPENED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701702 ↗
• MalfunctionJan 23, 2026Material Separation; Detachment of Device or Device Component; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PREFACE AND A BRIM CAP AND HEMOSTATIC VALVE SEPARATION OCCURRED. UPON OPENING THE PACKAGE, THE HEMOSTATIC VALVE COLLAPSE WAS FOUND. OPENED ANOTHER NEW ONE TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUES. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. ADDITIONAL INFORMATION RECEIVED INDICATING THE HEMOSTATIC VALVE WAS DISLODGED OUTSIDE THE HUB AND THE BRIM CAP HAD DETACHED FROM THE SHEATH. IT WAS DESCRIBED AS BROKEN/CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160622 ↗
• MalfunctionNov 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PREFACE SHEATH AND THE HEMOSTATIC VALVE WAS DISLODGED WHEN INSERTING THE CATHETER. THE ISSUE WAS RESOLVED BY REPLACING THE SHEATH WITH ANOTHER NEW ONE. AFTER THAT, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23538723 ↗
• MalfunctionJul 2, 2025Break; Device-Device Incompatibility; Material Protrusion/Extrusion; Break; Device-Device Incompatibility; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A PREFACE SHEATH. THE BRK NEEDLE WAS ADVANCED THROUGH THE PREFACE SHEATH AND THE DILATOR WAS SHEARED OFF. THE SHEATH WAS REPLACED AND THE CASE CONTINUED. NO PATIENT CONSEQUENCE. A FARAPULSE¿ GENERATOR WAS IN USE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391321 ↗
• MalfunctionJun 10, 2025Backflow; Backflow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PREFACE AND DURING THE FLUSH, SOMETHING RESEMBLING AIR WAS LEAKED FROM THE SYRINGE. THE PHYSICIAN DECIDED TO REPLACE THE PREFACE WITH A NEW ONE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT AIR WAS CONFIRMED INSIDE THE SIDE PORT. NO AIR WAS INTRODUCED INTO THE PATIENT. NO NEEDLE PRODUCT WAS USED WITH THE PREFACE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22181349 ↗
• MalfunctionMay 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PREFACE GUIDING SHEATH AND WHILE INSERTING A CATHETER INTO THE SHEATH, THE HEMOSTATIC VALVE OF THE PREFACE SHEATH WAS DISLODGED OUTSIDE THE HUB. THE ISSUE WAS RESOLVED BY REPLACING THE PREFACE WITH A NEW ONE. THE PROCEDURE WAS COMPLETED WITHOUT ANY DELAY AND WAS COMPLETED WITHOUT PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22058021 ↗
• MalfunctionNov 24, 2024Backflow; Backflow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A PREFACE SHEATH AND OBSERVED BLOOD RETURN FROM THE HEMOSTATIC VALVE. INITIALLY IT WAS REPORTED THAT THE PREFACE'S HEMOSTATIC VALVE WAS DAMAGED. TIMING WAS 1 HOUR AND 30 MINUTES AFTER THE START OF USE, AFTER PULMONARY VEIN ISOLATION (PVI) CAVOTRICUSPID ISHMUS (CTI) WAS COMPLETED, WHEN REINSERTING THE CATHETER TO THE LEFT ATRIUM (LA). THE ISSUE WAS RESOLVED BY REPLACING THE SHEATH TO ANOTHER NEW ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. THERE WAS NO REVERSE BLEEDING OR AIR CONTAMINATION DUE TO THIS. THE HEMOSTATIC VALVE ITSELF WAS NOT DAMAGED. ADDITIONAL INFORMATION WAS RECEIVED ON 06-OCT-2024 WHICH CLARIFIED THAT THE HEMOSTATIC VALVE GOT DAMAGED, ALTHOUGH IT WAS NOT BROKEN/CRACKED. THE SHEATH WAS BEING USED ON THE PATIENT. NO AIR ENTERED THE PATIENT¿S BODY. NO BLOOD RETURN WAS OBSERVED. ADDITIONAL INFORMATION WAS RECEIVED ON 04-NOV-2024. BLOOD RETURN FROM THE HEMOSTATIC VALVE WAS CONFIRMED. THE HEMOSTATIC VALVE DID NOT DISLODGE INSIDE THE HUB NOR OUTSIDE THE HUB. THE BRIM CAP / DID NOT BECOME DETACHED FROM THE SHEATH. THE APPROXIMATE VOLUME OF BLOOD THAT WAS LOST WAS A FEW DR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20768858 ↗
• MalfunctionJun 10, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A SUPERFICIAL DAMAGE IN THE SHAFT AT THE END OF THE VESSEL DILATOR. INITIALLY IT WAS REPORTED THAT THEY WERE UNABLE TO ADVANCE THE TRANSSEPTAL NEEDLE THROUGH THE DILATOR OF THE PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE. THE DILATOR WAS REPLACED WITH ONE FROM A NEW PREFACE SHEATH AND THE ISSUE RESOLVED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCE REPORTED. THE DILATOR OF THE PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE IS AVAILABLE OR RETURN. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 14-MAY-2024 THERE WAS A SUPERFICIAL DAMAGE IN THE SHAFT AT THE END OF THE VESSEL DILATOR. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF A SUPERFICIAL DAMAGE IN THE SHAFT AT THE END OF THE VESSEL DILATOR ON 14-MAY-2024 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19506975 ↗
• MalfunctionApr 19, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE AND THERE WAS PROBLEM WITH CONNECTOR OF THE DEVICE OR CABLE. THE MEDICAL TEAM CONFIRMED THAT THE COMPONENTS AT THE END OF THE DEVICE (HEMOSTATIC VALVE) FELL OFF. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19148091 ↗
• MalfunctionJun 27, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE AND THE HEMOSTATIC VALVE LEAKED. THE ISSUE OCCURRED DURING SHEATH INSERTION. THE SHEATH WAS REPLACED WITH A LIKE DEVICE--WHICH THEN HAD A HEMOSTATIC VALVE SEPARATION AFTER AN HOUR OF USAGE. THE SHEATH WAS REPLACED WITH A THIRD LIKE DEVICE. THE ISSUES WERE RESOLVED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED. HEMOSTATIC VALVE SEPARATION IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17207367 ↗
• MalfunctionJun 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE AND THE HEMOSTATIC VALVE LEAKED. THE ISSUE OCCURRED DURING SHEATH INSERTION. THE SHEATH WAS REPLACED WITH A LIKE DEVICE--WHICH THEN HAD A HEMOSTATIC VALVE SEPARATION AFTER AN HOUR OF USAGE. THE SHEATH WAS REPLACED WITH A THIRD LIKE DEVICE. THE ISSUES WERE RESOLVED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED. HEMOSTATIC VALVE LEAK IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17207365 ↗
• MalfunctionMar 31, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ABLATION PROCEDURE INVOLVING A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE IN WHICH THE HEMOSTATIC VALVE WAS DAMAGED DURING PREPARATION BEFORE USE AND DID NOT FILL NORMAL SALINE. THE VALVE WAS NOT DISLODGED INSIDE THE HUB. THE BRIM CAP AND HUB WERE NOT DISLODGED EITHER. THE SHEATH WAS REPLACED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. HEMOSTATIC VALVE SEPARATION IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16659442 ↗
• MalfunctionFeb 4, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE AND A HEMOSTATIC VALVE SEPARATION ISSUE OCCURRED. INITIALLY IT WAS REPORTED THAT A DEFECTIVE HEMOSTATIC VALVE WAS DETECTED DURING CATHETER INSERTION AND RESOLVED BY REPLACING THE SHEATH. THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT'S CONSEQUENCE. THE EVENT WAS ASSESSED AS NOT MDR REPORTABLE FOR A HEMOSTATIC VALVE DAMAGE ISSUE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS DETERIORATION IN STATE OF HEALTH WAS REMOTE. ADDITIONAL INFORMATION RECEIVED ON 12-JAN-2023. THE HEMOSTATIC VALVE WAS BROKE/SEPARATED. THE HEMOSTASIS VALVE DID NOT DISLODGE INSIDE OR OUTSIDE OF THE HUB. THE BRIM CAP/HUB DID NOT DETACH FROM THE SHEATH. THE SHEATH WAS BEING USED ON THE PATIENT. THERE WAS NO REFLUX OF BLOOD. THE ADDITIONAL INFORMATION OF THE HEMOSTATIC VALVE WAS BROKE/SEPARATED WAS ASSESSED AS MDR REPORTABLE FOR A HEMOSTATIC VALVE SEPARATION ISSUE. THEREFORE, THE MDR REPORTABLE AWARENESS DATE IS 12-JAN-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16301041 ↗
• MalfunctionNov 18, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE AND A HEMOSTATIC VALVE SEPARATION OCCURRED. IT WAS REPORTED THERE WAS DAMAGE OF THE HEMOSTATIC VALVE. THE ISSUE OCCURRED WAS DURING CATHETER REPLACEMENT (TIME OF ONSET UNKNOWN). THE PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE WAS REPLACED WITH A NEW PREFACE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. THE EVENT OCCURRED ON A DAY A BWI REPRESENTATIVE WAS NOT PRESENT DURING THE PROCEDURE AND WAS JUST FOUND OUT ABOUT THE ISSUE DUE TO THE OMISSION OF THE REPORT FROM THE AGENCY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15823757 ↗
• MalfunctionAug 30, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE. THERE WAS A VALVE PHYSICAL ABNORMALITY. THERE WAS A HEMOSTASIS VALVE FAILURE, VALVE PHYSICAL ABNORMALITY. REVERSE BLOOD WAS PRESENT AT THE TIME OF THE SEPTAL PUNCTURE INTO THE LEFT ATRIUM. THIS OCCURRED 1 HOUR AND 30 MINUTES AFTER INSERTION OF THE SHEATH, AT THE TIME OF THE SEPTAL PUNCTURE IN THE LEFT ATRIUM. THE CATHETER WAS EXCHANGED TO RESOLVE THE EVENT, AND THE PROCEDURE WAS CONTINUED. THE SHEATH WAS NOT BEING USED ON THE PATIENT. THE COMPLAINT PRODUCT WAS REPLACED TO ANOTHER SHEATH. BLOOD RETURN WAS OBSERVED. NO PATIENT CONSEQUENCES WERE REPORTED. HEMOSTATIC VALVE SEPARATION IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15317748 ↗
• MalfunctionJun 21, 2022Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE AND A HEMOSTATIC VALVE SEPARATION ISSUE OCCURRED. AFTER TRANSSEPTAL PUNCTURE, WHEN THE STSF WAS INSERTED INTO THE PREFACE GUIDING SHEATH, THE VALVE WAS BROKEN. THE PREFACE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. THE HEMOSTASIS VALVE (GASKET) DID NOT BREAK INTO TWO OR MORE SEPARATE PIECES. THE HEMOSTATIC VALVE/BRIM CAP/HUB DID NOT BECOME DETACHED FROM THE SHEATH. AIR DID NOT ENTER THE PATIENT¿S BODY. THE ISSUE DID NOT REQUIRE PERCUTANEOUS OR SURGICAL REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14752044 ↗
• MalfunctionFeb 22, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE. THE HEMOSTATIC VALVE WAS LEAKING. IT WAS REPORTED THAT AFTER INSERTING THE BROCKENBROUGH (B.B) TRANSSEPTAL NEEDLE, THERE WAS A TRACE OF REVERSED BLOOD FROM THE SHEATH. THIS OCCURRED 40 MINUTES AFTER THE PATIENT WAS ENTERED. THE ISSUE WAS RESOLVED BY CHANGING OUT THE PRODUCT. THE HEMOSTATIC VALVE WAS INTACT, AND THE REVERSED BLOOD VOLUME WAS A FEW DROPS. THERE WAS NO OCCURRENCE OF HEALTH HAZARD DUE TO REVERSED BLOOD. NO MEDICAL TREATMENT WAS PERFORMED IN ASSOCIATION WITH THE OCCURRENCE OF REVERSED BLOOD. THE PATIENT HAD NO AIR CONTAMINATION. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. THE PATIENT¿S HEMODYNAMICS WERE NOT COMPROMISED DUE TO BLEEDING. A FEW DROPS OF BLOOD WERE LOST, BUT THE EXACT AMOUNT IS UNKNOWN. IT WAS ALSO REPORTED THAT THE REVERSED BLOOD WAS COMING FROM THE HEMOSTATIC VALVE PORTION OF THE SHEATH. THE REVERSED BLOOD REPORTED WAS NOT RELATED WITH THE BB. HEMOSTATIC VALVE LEAK IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13575200 ↗
• MalfunctionFeb 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE AND A HUB DETACHMENT ISSUE OCCURRED. DURING THE PROCEDURE, THE COMPONENT FELL OFF. COMPONENT WAS SEPARATED FROM SHEATH. A SECOND CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SHEATH WAS NOT BEING USED ON THE PATIENT. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR A HUB DETACHMENT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13503529 ↗
• MalfunctionDec 22, 2021Backflow; Backflow

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN UNKNOWN ABLATION PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE. THERE WAS A BUBBLE IN THE TUBE. THERE WAS A BUBBLE AN IN THE TUBE, ALTHOUGH FLUSHED, IT COULD NOT BE REMOVED. THIS OCCURRED WHEN PREPARING, BEFORE THE START OF THE PROCEDURE, WAS ONGOING. THE PROCEDURE WAS COMPLETED BY FLUSHING THE TUBE, BUT THE ISSUE CONTINUED, SO SHEATH WAS CHANGED, PROCEDURE WAS STARTED AS NORMAL. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. AIR WAS NOT BEING INTRODUCED INTO THE PATIENT. THE PHYSICIAN DID NOT PERFORMED ANY MANEUVER TO ELIMINATE BUBBLES. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT HAS NOT EXHIBITED ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. AIR FLOW INTO SIDE PORT IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13058763 ↗
• MalfunctionOct 31, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE AND A HEMOSTATIC VALVE SEPARATION ISSUE OCCURRED. THE VALVE CAP BROKE OFF AND WAS DETACHED FROM THE SHEATH AT THE BEGINNING OF THE PROCEDURE. THE HEMOSTASIS VALVE (GASKET) DID NOT BREAK INTO TWO OR MORE SEPARATE PIECES. THE HEMOSTATIC VALVE/BRIM CAP/HUB DID BECOME DETACHED FROM THE SHEATH. THE ISSUE WAS NOTICED BEFORE ANY CATHETERS WERE INSERTED INTO THE SHEATH. NO AIR ENTERED THE PATIENT AND THIS ISSUE DID NOT REQUIRE PERCUTANEOUS OR SURGICAL REMOVAL. THE SHEATH WAS REPLACED AND THE ISSUE RESOLVED. THE SHEATH IS BEING RETURNED ALONG WITH THE CAP. THE EVENT WAS ASSESSED AS A MDR REPORTABLE HEMOSTATIC VALVE SEPARATION ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12725758 ↗
• InjuryJul 23, 2021Backflow; Material Twisted/Bent; Patient Device Interaction Problem; Backflow; Material Twisted/Bent; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) ABLATION PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE WHEREIN AIR ENTERED THE PATIENT AND THE PATIENT HAD ELECTROCARDIOGRAM ST SEGMENT ELEVATION. WHEN MAPPING INSIDE THE CARDIAC CAVITY, ST INCREASED, AND AIR WAS FOUND IN THE RIGHT CORONARY ARTERY AND AORTA. WHEN THE CATHETER WAS REMOVED FROM THE PATIENT¿S BODY AND FLUSHED, THE AIR BLEW OUT. THIS OCCURRED AFTER MAPPING INSIDE THE CARDIAC CAVITY. THE CATHETER AND THE PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE WERE REMOVED FROM THE PATIENT¿S BODY, AND WHEN FLUSHED, AIR WAS CHECKED AND THE PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE WITH AIR WAS REPLACED WITH SL0. ADDITIONAL INFORMATION RECEIVED INDICATED THE PHYSICIAN SAID THAT THERE WAS NO DOUBT THAT AIR ENTERED FROM THE SHEATH, BUT IT WAS UNKNOWN WHETHER THIS PRODUCT WAS THE CAUSE.

  Patient problems: Air Embolism; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12215813 ↗