INFINITI 538476Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032014922), received between Dec 9, 2019 and Mar 16, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE DISTAL TIP OF 4F 100CM 3-DIMENSIONAL RIGHT CORONARY (DRC) INFINITI DIAGNOSTIC CATHETER WAS DETACHED FROM THE CATHETER BODY AFTER REMOVING THE DEVICE FROM A 4F NON-CORDIS SHEATH. THE SCRUB TECH INFORMED THE PHYSICIAN AND THE PHYSICIAN ASSUMED THAT THE "FOREIGN BODY" WAS STILL ON THE WIRE AND POSSIBLE INSIDE THE SHEATH. HOWEVER, AFTER DOING FLUOROSCOPY UP FROM THE FEMORAL ARTERY TO THE AORTA THEY WERE UNABLE TO FIND THE "FOREIGN BODY" IN BOTH FEMORAL AND IN THE AORTA. THEY CONTINUE DOING THE FLUOROSCOPY DOWN THE RIGHT ILIAC AND THEY "FOUND THE FOREIGN" BODY WAS SECURED IN THE PROFUNDA ARTERY. THEY THEN COMPLETED THE LEFT VENTRICULOGRAM (LVGRAM) AND REMOVED THE SHEATH, HOLDING A MANUAL COMPRESSION , PHYSICIAN WAS CALLED IN TO REMOVE THE CATHETER TIP. THE PHYSICIAN WENT IN THE LEFT COMMON FEMORAL ARTERY AND REMOVED THE FOREIGN BODY BY GETTING AN 0.014" WIRE THROUGH THE TIP. HE THEN RAN A SMALL BALLOON INTO THE TIP, INFLATED, AND SUCCESSFULLY REMOVED THE TIP. NO ADVERSE PATIENT EFFECTS, OUTSIDE OF THE SECONDARY SURGERY. THE PROCEDURE WAS LEFT HEART CATHETERIZATION AFTER A RIGHT CORONARY ANGIOGRAM. A 0.035" UNKNOWN GUIDEWIRE WAS INSERTED THROUGH THE INFINITI 3DRC CATHETE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9834762 ↗
• MalfunctionDec 9, 2019Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, A 4F 100CM RIGHT CORONARY 3-DIMENSIONAL (3DRC) INFINITI DIAGNOSTIC CATHETER WAS KINKED WITH A HOLE DURING PREP. IT WAS NOTICED THAT THE DEVICE WAS KINKED AFTER PRE-LOADING THE J-WIRE. A J-WIRE WHICH IS FRESH OUT OF PACKAGE WENT THROUGH HOLE. THEREFORE, THE PROCEDURE WAS COMPLETED USING ANOTHER UNKNOWN DIAGNOSTIC CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE PRIOR TO USE. THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THE DEVICE WAS OPENED IN THE STERILE FIELD. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9438648 ↗