PINNACLE RSB811Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00389701009162), received between May 13, 2016 and May 13, 2016 — classified as 1 injury.

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

• InjuryMay 13, 2016Break; Break

  THE USER FACILITY REPORTED SHEARING OF THE WIRE TIP ON THE INVOLVED DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: DURING ACCESS THE DOCTOR FELT RESISTANCE WHEN ADVANCING THE WIRE AND PULLED BACK TO GET A DIFFERENT ANGLE; THE WIRE BECAME RESISTANT TO COME BACK; THE DOCTOR DECIDED TO REMOVE THE NEEDLE AND WIRE TOGETHER; WHEN REMOVED, IT WAS NOTICED THAT THE WIRE WAS SHEARED OFF AT THE TIP; FLUORO OF THE GROIN SHOWED THAT THE WIRE WAS PRESENT BUT WAS NOT INTRAVASCULAR; THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SMALL INCISION UNDER FLUORO WHERE THE WIRE WAS REMOVED; POST FLUORO SHOWED NO WIRE PRESENT; BLOOD LOSS WAS LESS THAN 250ML; AND THERE WAS NO HARM TO THE PATIENT, JUST PROLONGED THE CASE.

  Patient problems: Blood Loss; Device Embedded In Tissue or Plaque

  MAUDE report 5654001 ↗