PINNACLE PRECISION ACCESS SYSTEM 70-6130Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00389701010489), received between Feb 20, 2018 and Aug 16, 2018 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 16, 2018Difficult to Remove; Difficult to Remove

  THE USER FACILITY REPORTED THAT THE IK WIRE WAS NOT ADVANCING SMOOTHLY WHEN THE PHYSICIAN WAS OBTAINING ACCESS AND ADVANCING THE WIRE INTO THE NEEDLE. UPON TRYING TO REMOVE THE WIRE IT BECAME STUCK IN THE NEEDLE. THE NEEDLE AND WIRE WERE REMOVED TOGETHER AND MANUAL PRESSURE WAS USED AT THE SITE. A 18 GAUGE NEEDLE WAS USED AND A 6 FR PINNACLE SHEATH WAS THEN INSERTED TO COMPLETE THE CASE SUCCESSFULLY. THE BLOOD LOSS WAS LESS THAN 250 CC'S. THE PATIENT IS IN STABLE CONDITION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED ON 8/8/18: THE PROCEDURE WAS A LEFT HEART CARDIAC CATHETERIZATION

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 7789495 ↗
• MalfunctionAug 15, 2018Failure to Advance; Failure to Advance

  THE USER FACILITY REPORTED THAT AFTER THE DOCTOR GAINED ACCESS WITH THE INTRO NEEDLE HE INSERTED A MINI GUIDEWIRE IK DEVICE. AFTER MULTIPLE ATTEMPTS TO ADVANCE, THE WIRE COULD NOT BE REMOVED FROM THE NEEDLE. THE WIRE AND NEEDLE WERE PULLED OUT TOGETHER AND THE WIRE TIP WAS NOTED TO BE MANGLED AND "TIED IN A KNOT". THE DOCTOR TRIED TO ADVANCE TWO DIFFERENT SHEATHS, HOWEVER, THEY WOULD NOT ADVANCE. THE DOCTOR THEN SWITCHED TO A REGULAR PINNACLE SHEATH AND PROCEEDED WITH THE CASE. THERE WAS NO INJURY TO THE PATIENT. THE PATIENT WAS STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 8/13/18. THE PROCEDURE BEING PERFORMED WAS A PERIPHERAL INTERVENTION (LEFT LEG).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7784855 ↗
• MalfunctionJun 15, 2018Break; Break

  THE USER FACILITY REPORTED THAT THE PHYSICIAN EXPERIENCED DIFFICULTY WHEN ATTEMPTING TO GAIN FEMORAL ACCESS WITH A PRECISION DEVICE. IT WAS REPORTED THAT THE WIRE BROKE APART DURING INSERTION OF THE SHEATH. THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WERE NO PARTS OF THE DEVICE REMAINING IN THE PATIENT. THE PATIENT HAD A LARGE PANUS. THE PATIENT IS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 6/5/2018: IT WAS REPORTED THAT THERE WAS NO BLOOD LOSS. THE DEVICE CAME OUT OF BODY WHEN THE ENTIRE SYSTEM WAS REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7605429 ↗
• MalfunctionFeb 20, 2018Kinked; Kinked

  ADDITIONAL INFORMATION WAS RECEIVED ON 2/7/2018: IT WAS REPORTED THAT THE PATIENT'S CONDITION WAS GOOD AND THE PROCEDURE WAS A SUCCESS. IT WAS REPORTED THEY OPENED ANOTHER PACK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7284122 ↗