PINNACLE PRECISION ACCESS SYSTEM 70-8130Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00389701010502), received between Oct 11, 2018 and Oct 11, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Advance” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2018Difficult to Advance; Difficult to Advance

  THE USER FACILITY REPORTED THAT WHILE USING A PRECISION DEVICE THE 021 WIRE WOULD NOT PASS THROUGH THE HUB INTO THE BODY OF THE NEEDLE. THE REPORTED BLOOD LOSS WAS LESS THAN 250CC. THE PATIENT WAS REPORTED TO BE STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WERE NO OTHER EQUIPMENT OR OTHER DEVICES WERE USED WITH THE REPORTED PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON 9/28/18: THE TYPE OF PROCEDURE BEING PERFORMED WAS A NEURO INTERVENTIONAL PROCEDURE, PIPELINE PLACEMENT FOR A RESIDUAL ANEURYSM. A COOK MICRO PUNCTURE KIT WAS OPENED, ACCESS WITH THE COOK NEEDLE WAS GAINED, 018 COOK WIRE WAS THEN USED TO INTRODUCE THE MICRO PUNCTURE INTRODUCER SHEATH. THEN THE 021 SS WIRE WAS PLACED FOLLOWED BY THE 8FR PRECISION SHEATH.

  Patient problems: Blood Loss

  MAUDE report 7956117 ↗