PINNACLE RSB502Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00389701009315), received between Apr 26, 2019 and Jan 13, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE INTRODUCER KIT (IK) SHEATH WOULD NOT RESPOND TO A PRESSURE DRIP DURING ARTERIAL CASE. THEY TRIED TO RE-PRIME THE SHEATH AND IT CAME APART. A DIFFERENT SHEATH WAS PULLED, AND THEY WERE ABLE TO SUCCESSFULLY EXCHANGE THE SHEATH AND COMPLETE THE CASE WITH THE NEW SHEATH. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS STABLE, AND THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2020. THE DEVICE WAS IN THE PATIENT, HOWEVER THE VALVE WAS THE PORTION THAT BROKE, SO THAT PIECE WAS ALWAYS OUTSIDE THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11159987 ↗
• MalfunctionSep 17, 2019Break; Break

  THE USER FACILITY REPORTED THAT THE PINNACLE SHEATH DISTAL TIP OF THE IK 5FR DILATOR SHEARED OFF. IT WAS A SMOOTH SEPARATION AS IF IT WERE CUT. THE TECH NOTICED BEFORE LOADING ON THE WIRE; SHE HAD ATTEMPTED TO LOAD ON THE WIRE; HOWEVER, HAD NOT. THE CASE WAS A LEG ANGIO PERFORMED BY THE DOCTOR. A SECOND SHEATH WAS REQUESTED AND OPENED. THE PROCEDURE WAS CONTINUED AND COMPLETED WITHOUT DELAY OR INJURY. THE DEVICE NEVER TOUCHED THE PATIENT, THEIR CONDITION WAS REPORTED TO BE UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 29AUG2019. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9075805 ↗
• MalfunctionApr 26, 2019Break; Break

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH WITH ADDITIONAL INFORMATION ON APRIL 5, 2019. THE EVENT DESCRIPTION STATES: AFTER ESTABLISHING ACCESS, THE DOCTOR WAS TRYING TO FEED THE INTRODUCER INTO THE SHEATH. THE DOCTOR WAS UNABLE TO ADVANCE DUE TO THE TIP BEING BROKEN. THE BROKEN ITEM WAS REMOVED FROM SURGICAL FIELD AND A NEW SHEATH SET OPENED TO STERILE FIELD. THE PATIENT PROCEDURE WAS A ATHEROSCLEROSIS OF NATIVE ARTERY OF BOTH LOWER EXTREMITIES WITH REST PAIN AND TISSUE LOSS. ADDITIONAL INFORMATION WAS RECEIVED APRIL 24, 2019: THERE WAS NO INTERVENTION REQUIRED FOR THE PATIENT. IT WAS NOT CONFIRMED IF THE ACTUAL TIP OF THE DEVICE BROKE OFF, OR WAS ACTUALLY DAMAGED CAUSING THE ISSUE WITH ADVANCEMENT

  Patient problems: No Information

  MAUDE report 8556733 ↗