Prelude IDeal™ 10884450381868Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884450381868), received between Oct 27, 2020 and Jul 1, 2022 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Defective Device” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2022Failure to Advance; Material Twisted/Bent

  EARLY 50¿S MALE WITH HISTORY OF CHEST PAIN AND SUSPECTED CORONARY HEART DISEASE. PROCEDURE: LEFT AND RIGHT CORONARY HEART CATHETERIZATION. FIRST SHEATH DILATATOR KINKED WHEN USED, 2ND SHEATH WOULD NOT GO OVER THE FIRST ONE. ALL REMOVED WITHOUT KNOWN HARM TO PATIENT. NEW ACCESS WITH THIRD SHEATH THAT WAS SUCCESSFUL. MINOR DELAY IN PROCEDURE. MANUFACTURER RESPONSE FOR INTRODUCER, CATHETER, PRELUDE IDEAL (PER SITE REPORTER) WILL OBTAIN. MANUFACTURER RESPONSE FOR INTRODUCER, CATHETER, PRELUDE IDEAL (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14884899 ↗
• MalfunctionApr 14, 2022Defective Device

  ELDERLY FEMALE WITH HISTORY OF CORONARY ARTERY DISEASE (CAD), DEEP VEIN THROMBOSIS (DVT) AND RECENT CHEST PAIN. PROCEDURE: L&R CORONARY ANGIOPLASTY, L HEART CATH, PERCUTANEOUS CORONARY INTERVENTION (PCI) IN MID- LEFT ANTERIOR DESCENDING ARTERY (LAD) AND STENT PLACEMENT. PHYSICIAN AND RN WERE UNABLE TO LOAD SHEATH ONTO ACCESS WIRE. NO KNOWN HARM TO PATIENT, MINOR DELAY. NEW SHEATH USED WITHOUT PROBLEMS. MANUFACTURER RESPONSE FOR INTRODUCER, CATHETER, PRELUDE IDEAL¿ (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14111154 ↗
• InjuryFeb 2, 2022Unraveled Material; Unraveled Material

  THE ACCOUNT ALLEGES THAT DURING ACCESS FOR A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOGRAM [PTCA] PROCEDURE, THE 6F ACCESS WIRE UNRAVELED WITHIN THE PATIENT VASCULAR SYSTEM. THE WIRE WAS NO LONGER ABLE TO BE USED FOR VASCULAR ACCESS AND HAD TO BE REMOVED. A VASCULAR SURGEON WAS CONSULTED TO ASSIST IN THE REMOVAL OF THE ACCESS WIRE WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13426005 ↗
• MalfunctionJul 14, 2021Deformation Due to Compressive Stress

  PATIENT WITH HISTORY OF DIABETES MELLITUS, HYPERTENSION, COLON CANCER AND PERIPHERAL VASCULAR DISEASE WAS ASSESSED IN THE EMERGENCY DEPARTMENT DUE TO COMPLAINS OF A NEW ONSET OF WEAKNESS. THE PATIENT WAS ADMITTED FOR A LEFT HEART CATHETERIZATION WITH LEFT AND RIGHT CORONARY ANGIOGRAPHY. THE RADIAL SHEATH, FROM THE PRELUDE IDEAL¿ VASCULAR CATHETER INTRODUCTION SET, KINKED AT THE PROXIMAL END OF THE HUB. ANOTHER PRODUCT WAS USED FOR THE MEDICAL PROCEDURE. NO KNOWN HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12165708 ↗
• InjuryJul 8, 2021Fracture; Difficult to Insert; Difficult to Remove; Material Separation; Fracture; Difficult to Insert; Difficult to Remove; Material Separation

  THE ACCOUNT ALLEGES WHILE ACCESSING THE FEMORAL ARTERY USING THE IDEAL SHEATH, THE WIRE WENT INTO THE ARTERY BUT THE SHEATH WAS DIFFICULT TO ADVANCE. THE DILATOR WAS PULLED OFF THE SHEATH AND ATTEMPTED TO INSERT INTO THE ARTERY. THE ATTEMPT FAILED AND RESULTED IN THE DIALATOR BEING BENT AND REMOVED SUCCESSFULLY. THE GROIN HAD A LOT OF SCAR TISSUE AND THE ARTERY WAS HEAVILY CALCIFIED. RETRACTING THE WIRE WAS DIFFICULT AND IS BELIEVED TO HAVE POTENTIALLY BEEN CAUGHT ON CALCIUM. ADDITIONAL FORCE WAS APPLIED TO THE WIRE IN ATTEMPT TO REMOVE IT. THE WIRE SEPARATED WITHIN THE FEMORAL ARTERY. PRESSURE WAS HELD ON THE GROIN AND A SAFEGUARD FEMORAL WAS PLACED. THE PATIENT WAS SENT BY AMBULANCE TO THE HOSPITAL TO HAVE THE WIRE SURGICALLY REMOVED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12137848 ↗
• MalfunctionMay 11, 2021Material Twisted/Bent

  A FEMALE PATIENT WITH A HISTORY OF HYPERTENSION, CHRONIC HEART FAILURE, AND INCREASED SHORTNESS OF BREATH WAS ADMITTED FOR A LEFT AND RIGHT CARDIAC CATHETERIZATION. THE RADIAL WIRE, FROM THE PRELUDE IDEAL" VASCULAR CATHETER INTRODUCTION SET, WAS BENT UPON REMOVING IT FROM THE PACKAGE. DEVICE WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805547 ↗
• MalfunctionMay 11, 2021Unraveled Material

  A PATIENT WITH A HISTORY OF HYPERTENSION AND CORONARY ARTERY DISEASE WAS ADMITTED FOR A RIGHT AND LEFT ANGIOGRAPHY, BALLOON ANGIOPLASTY AND STENT PLACEMENT. SURGICAL PROCEDURE WAS COMPLETED. WHEN THE INTRODUCER SHEATH, FROM THE PRELUDE IDEAL" VASCULAR CATHETER INTRODUCTION SET, WAS BEING REMOVED, THERE WAS BLEEDING FROM THE PROXIMAL END OF THE HUB AND THE SHEATH APPEARED UNCOILED (DIFFERENT THICKNESS WAS EVIDENCED IN THE TUBING). NO KNOWN HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805504 ↗
• MalfunctionApr 19, 2021Break; Physical Resistance/Sticking

  A (B)(6) YEARS-OLD PATIENT WITH A HISTORY OF HYPERTENSION WAS A UNDERGOING A LEFT HEART CATHETERIZATION PROCEDURE. WHILE USING THE PRELUDE IDEAL¿ VASCULAR CATHETER INTRODUCTION SET, RESISTANCE MET AND THE SHEATH DILATOR BROKE WHILE IN VESSEL. ATTENDING PHYSICIAN REMOVED ALL PIECES, NO KNOWN HARM TO PATIENT. NEW PRODUCT OBTAINED AND PROCEDURE DONE THROUGH ANOTHER SITE. SALES MANUFACTURER WAS PRESENT DURING THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 11684663 ↗
• MalfunctionApr 2, 2021Difficult to Insert; Defective Device

  A (B)(6) PATIENT WITH A HISTORY OF CORONARY ARTERY DISEASE UNDERWENT A DIAGNOSTIC HEART CATHETERIZATION. DURING THE PROCEDURE, 6F PRELUDE IDEAL HYDROPHILIC SHEATH WOULD NOT PASS OVER THE INTRODUCER WIRE DUE TO A DEFECT INSIDE THE INNER DILATOR BLOCKING THE WIRE DURING ITS INSERTION. ANOTHER DEVICE WAS USED FOR THE PROCEDURE. PLEASE NOTE THIS IS THE 3RD INCIDENT WITH THE PRELUDE IDEAL¿ WITH THE SAME COMPLAINT. PLEASE REFER TO REPORTS (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11607129 ↗
• MalfunctionApr 1, 2021Break

  A (B)(6) YEARS OLD PATIENT WITH A HISTORY OF HYPERTENSION, DIABETES MELLITUS, AND CIRRHOSIS WAS ADMITTED WITH A NEW ONSET OF CHEST PAIN. IN THE CATHETERIZATION LABORATORY, A DIAGNOSTIC CATH WAS GOING TO BE PERFORMED WHEN THE TIP OF A PRELUDE IDEAL¿ VASCULAR CATHETER INTRODUCTION SET BROKE WHEN ATTEMPTING TO INSERT THE DILATOR INTO THE SHEATH. THE BROKEN PIECE WAS NOTICED BY ONE OF THE HEALTH CARE PROVIDERS. MOREOVER, AS SEEN IN THE ATTACHED IMAGES, THE BROKEN PIECE CAUSED THE DEVICE TO HAVE A JAGGED EDGE. THE FAULTY PRELUDE IDEAL¿ VASCULAR CATHETER INTRODUCTION SET WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11601753 ↗
• MalfunctionMar 29, 2021Failure to Advance

  ELDERLY FEMALE WITH HISTORY OF OBSTRUCTIVE CARDIOMYOPATHY. WHILE HAVING A DIAGNOSTIC HEART CATHETER, THE J WIRE WAS UNABLE TO PASS THROUGH THE INNER DILATOR OF THE RADIAL SHEATH. NO KNOWN HARM TO PATIENT, ANOTHER DEVISE WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 11580994 ↗
• MalfunctionMar 26, 2021Material Twisted/Bent

  ELDERLY MALE WITH HISTORY OF CORONARY ARTERY DISEASE, HYPERTENSION AND DIABETES. TO EMERGENCY DEPT WITH NEW ONSET CHEST PAIN AND FOR DIAGNOSTIC HEART CATH. WHEN THE MERIT MEDICAL PRELUDE IDEAL 6F HYDROPHILIC SHEATH WAS REMOVED FROM THE PACKAGING, THE TIP WAS BENT. DEVICE NOT USED ON THE PATIENT; ANOTHER DEVICE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11574082 ↗
• MalfunctionMar 17, 2021Difficult to Advance

  ELDERLY MALE WITH HISTORY OF HYPERTENSION AND OBESITY. PROCEDURE IS DIAGNOSTIC HEART CATHETER; THE PHYSICIAN WAS UNABLE TO PASS WIRE OF THE 6F PRELUDE, SHEATH INTRODUCER THROUGH INNER DILATOR. NO KNOWN HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11503869 ↗
• MalfunctionNov 18, 2020Defective Device

  ELDERLY MALE WITH HISTORY OF DIABETES, CORONARY ARTERY DISEASE AND SHORTNESS OF BREATH. WHILE HAVING A DIAGNOSTIC HEART CATHETERIZATION, THE PRELUDE DILATOR DID NOT HAVE A HOLE AT THE END. WHEN IRRIGATED, IT WAS DIFFICULT BUT SOME IRRIGANT CAME OUT THROUGH THE SIDES LIKE A SPRINKLER. NO KNOWN HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10859940 ↗
• MalfunctionNov 9, 2020Defective Device

  MIDDLE AGED FEMALE WITH PRESENTATION OF CHEST PAIN AND HYPERTENSION. IN THE HEART CATH LAB, HAVING A HEART CATHETERIZATION, THE MERIT PRELUDE RADIAL SHEATH DILATOR DID NOT HAVE A HOLE FOR THE WIRE. IT WAS MANUFACTURED CLOSED. REMOVED FROM THE PATIENT WITHOUT DIFFICULTY, NO KNOWN HARM TO PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 10808641 ↗
• MalfunctionOct 29, 2020Material Puncture/Hole

  ELDERLY FEMALE WITH HISTORY OF HYPERTENSION, CORONARY ARTERY DISEASE AND DIABETES. SHE PRESENTED WITH CHEST PAIN AND WAS TAKEN TO HEART LAB. WHILE FLUSHING THE MERIT SHEATH INTRODUCER, THE DILATOR HAD MICRO HOLES IN IT. IT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10754847 ↗
• MalfunctionOct 27, 2020Material Twisted/Bent

  ELDERLY MALE WITH HISTORY OF HYPERTENSION AND CORONARY ARTERY DISEASE PRESENTED WITH SHORTNESS OF BREATH. WHILE HAVING A HEART CATHETERIZATION, THE DEVICE WAS REMOVED FROM PACKAGING AND THE WIRE WAS BENT. THE WIRE WAS NOT USED ON THE PATIENT, NO KNOWN HARM TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 10739795 ↗