PINNACLE RSS501Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00389701007243), received between Mar 26, 2018 and Jan 3, 2020 — classified as 1 injury, 1 malfunction.

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. 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.

• InjuryJan 3, 2020Difficult to Remove; Difficult to Advance; Material Deformation; Difficult to Remove; Difficult to Advance; Material Deformation

  THE USER FACILITY REPORTED THAT AFTER ACCESSING THE FEMORAL VEIN, THE DOCTOR TRIED TO REPOSITION THE WIRE, HOWEVER IT WOULD NEITHER ADVANCE NOR PULL BACK. INSPECTION OF WIRE SHOWED THAT THE WIRE COIL SURROUNDING IT HAD BROKEN AND THE WIRE PULLED APART. THE DOCTOR WAS PRESENT TO SAFELY REMOVE THE WIRE. THE WIRE DID NOT BREAK APART; HOWEVER, IT WAS STRETCHED. THE WIRE WAS INTACT. ADDITIONAL INFORMATION WAS RECEIVED ON 04DEC2019. THE TYPE OF PROCEDURE THAT WAS BEING PERFORMED WAS AN EP STUDY- FLUTTER ABLATION. THE PATIENT CONDITION WAS STABLE. THE PROCEDURE WAS ABLE TO BE COMPLETED. A SURGICAL INTERVENTION WAS NOT REQUIRED. HOWEVER, THE VASCULAR SURGEON WAS REQUESTED TO COME IN TO ATTEMPT TO SNARE THE WIRE, HOWEVER, WAS UNSUCCESSFUL. HE THEN OPTED TO REMOVE THE INTACT WIRE MANUALLY WITH SOMEONE READY TO APPLY PRESSURE IF NECESSARY. NO CALCIUM OR TORTUOSITY WAS NOTED IN THE VENOUS STICK. AN 18G THIN WALL COOK NEEDLE WAS USED. THE WIRE WAS NEVER BROKEN IN PIECES, HOWEVER, THE RISK OF THAT HAPPENING WAS THE CONCERN AND WHY THEY HAD THE VASCULAR SURGEON REMOVE IT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9546517 ↗
• MalfunctionMar 26, 2018Kinked; Kinked

  THE USER FACILITY REPORTED THAT THE 5 FR. PINNACLE SHEATH KINKED IN AN ARTERY DURING A LEFT HEART CATH. IT WAS A SINGLE STICK. THE ENTRY ANGLE WAS STEEPER THAN 45%, WHICH PROBABLY CONTRIBUTED TO THE KINK. THE PHYSICIAN HAD DIFFICULTY ADVANCING AND TORQUEING THE CATHETERS. THE SHEATH WAS SWITCHED OUT FOR AN UNKINKED SHEATH AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO INJURY TO PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 3/7/18: IT WAS REPORTED THAT THERE WAS A MINIMAL BLOOD LOSS WHEN GETTING ACCESS.

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

  MAUDE report 7369827 ↗