PINNACLE RSS502Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00389701007465), received between May 17, 2017 and Feb 21, 2024 — classified as 3 injuries, 3 malfunctions.

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

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2024Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE INVOLVED IK DEVICE PROXIMAL PORTION OF THE SHEATH CRUMBLED UPON INSERTION. ATTEMPTED TO INSERT THE WIRE THROUGH THE SHEATH AND WAS UNABLE TO. THE SHEATH WAS CUT TO TRY AND GET WIRE ACCESS. THIS WAS NOT SUCCESSFUL, AND ACCESS TO THE VESSEL WAS LOST. THE PATIENT WAS NOT INJURED DURING THE EVENT AND MEDICAL/SURGICAL INTERVENTION WAS NOT NEEDED. ADDITIONAL INFORMATION WAS RECEIVED ON 26 JAN 2024: PATIENT PROCEDURE WAS A NEURO DIAGNOSTIC PROCEDURE. TO RESOLVE THE ISSUE, THE SHEATH WAS PULLED, AND VESSEL ACCESS WAS LOST. PRESSURE WAS HELD AT THE SITE. NO DIFFICULT ANATOMY NOTED. THE PATIENT WAS IN STABLE CONDITION. NO CONCOMITANT MEDICAL PRODUCTS WERE USED WITH THE INVOLVED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18755200 ↗
• InjuryJan 20, 2024Break; Break

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW514836. THE EVENT DESCRIPTION STATES: AN 8 CM OF THE INTRODUCER SHEATH BROKE OFF INSIDE PATIENT IN PREPARATION FOR CARDIAC SURGERY. WE HAVE NEVER EXPERIENCED A PROBLEM WITH THIS PRODUCT BEFORE. DEVICE EMBEDDED IN TISSUE OR PLAQUE."

  Patient problems: Foreign Body In Patient

  MAUDE report 18549007 ↗
• MalfunctionMar 1, 2023Obstruction of Flow; Obstruction of Flow

  THE USER FACILITY REPORTED THAT WHILE TRYING TO ASPIRATE FROM THE SHEATHS SIDEPORT, THE DOCTOR WAS UNABLE TO DRAW ANY BLOOD. SHE SUSPECTED THERE MAY BE A CRACK IN THE SHEATHS SIDE PORT AND DECIDED TO EXCHANGE FOR ANOTHER 5FR PINNACLE SHEATH. THE CASE WAS AN ABDOMINAL ANGIOGRAM WITH RUNOFF (AARO)/DIAGNOSTIC OF THE RIGHT LEG. THE SHEATH WAS SUCCESSFULLY PLACED IN THE LEFT GROIN WITH NO ISSUES. PICTURES WERE TAKEN WITH THE ORIGINAL SHEATH. THE ATTEMPT TO ASPIRATE WAS DONE MID CASE WHEN THE ISSUE WAS NOTICED. THE PROCEDURE CONTINUED SUCCESSFULLY AFTER THE SHEATH EXCHANGE. THE PATIENT WAS STABLE. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON 06 FEB 2023: SHE WAS PULLING BACK AIR, NOT BLOOD, AND SUSPECTED A CRACK OR HOLE. WHEN THEY WERE ASPIRATING, THEY USED A SYRINGE AND PULLING FROM THE 3-WAY STOPCOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16462185 ↗
• InjuryMar 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDWATCH REPORT WAS RECEIVED ON (B)(6) 2021. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2021. THE PROCEDURE BEING PERFORMED WAS AN ELECTROPHYSIOLOGY (EP) ABLATION. WHEN THE SHEATH WAS BEING PULLED, THE SHEATH HUB SEPARATED FROM THE SHAFT. THE USER FACILITY STATED THAT THEY DID NOT BELIEVE THE SHEATH CAUSED THE PSEUDOANEURYSM. THE PATIENT WAS EVENTUALLY TAKEN TO SURGERY AND THE VASCULAR SURGEON CLOSED HER UP.

  Patient problems: Hematoma; Pseudoaneurysm

  MAUDE report 11397091 ↗
• MalfunctionSep 18, 2019Difficult to Remove; Difficult to Advance; Material Deformation; Difficult to Remove; Difficult to Advance; Material Deformation

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT #: 2300170000-2019-8015. THE EVENT DESCRIPTION STATES: "APPROXIMATELY 2 MONTH AGO, WE WERE PLACING A 5FR PINNACLE AFTER USING A MICRO PUNCTURE FOR GROIN ACCESS. WE HAD FED THE WIRE FROM THE PINNACLE THROUGH THE INTRODUCER OF THE MICRO PUNCTURE WHICH APPEARED TO GO JUST FINE. UPON FEEDING THE SHEATH OVER THE WIRE, IT WAS OBSERVED THAT THE SHEATH WOULD NOT ADVANCE. SHEATH WAS REMOVED AND WIRE APPEARED TO BE STUCK TO THE SUBCUTANEOUS TISSUE. DR. ATTEMPTED TO REMOVE THE WIRE, REALIZING THAT IT WAS STUCK AND NOT BUDGING HE CALLED ANOTHER DOCTOR TO ASSIST. THE DOCTOR WAS SUCCESSFUL IN REMOVING THE WIRE ALL IN ONE PIECE. VISUALIZING THE WIRE POST REMOVAL THERE ARE TWO KINKS. THIS HAPPENED DURING THE ORIGINAL INTENDED PROCEDURE OF A DIAGNOSTIC CEREBRAL ANGIOGRAM". ADDITIONAL INFORMATION WAS RECEIVED ON 04SEPT2019. THE PATIENT WAS DISCHARGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9083800 ↗
• MalfunctionMay 17, 2017Detachment Of Device Component; Detachment Of Device Component

  THE USER FACILITY REPORTED THE DISTAL TIP OF THE DILATOR CAME OFF THE (B)(4) DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE SPECIFIC DATE IS UNKNOWN AT THIS TIME; THE ISSUE OCCURRED AS IT WAS BEING LOADED OVER THE GUIDEWIRE, PRIOR TO INSERTION INTO THE PATIENT; IT WAS REPORTED THAT PHYSICIAN AND STAFF NOTICED THE PIECE, AND PROMPTLY REMOVED BOTH ITEMS FROM THE GUIDEWIRE AND SET ASIDE; THE PROCEDURE WAS SUCCESSFUL; AND THE PATIENT WAS UNAFFECTED. ADDITIONAL INFORMATION WAS PROVIDED ON 5/15/17. IT WAS REPORTED THAT THE SAMPLE WAS NOT USED ON THE PATIENT. THE DILATOR WAS INSERTED IN THE SHEATH AND THEN THE SHEATH AND DILATOR WERE PUT OVER THE WIRE. IT WAS NOTED ONCE THE SHEATH/DILATOR WERE TRACKING OVER THE WIRE THAT THE TIP OF THE DILATOR HAD BECOME DETACHED. THE DEVICE NEVER ENTERED THE PATIENT'S BODY AND WAS REMOVED FROM THE WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6572259 ↗