Pacific™ Plus PCP050120130Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033477054759), received between Jul 14, 2017 and Sep 30, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE A PACIFIC PLUS ALONG WITH NON-MEDTRONIC 6FR SHEATH, AND 0.018" GUIDE WIRE DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL WAS LITTLE TORTUOUS. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUE IDENTIFIED. IT WAS REPORTED THAT DURING 3RD BALLOON INFLATION, BALLOON LEAK WITH PIN HOLE WAS NOTED AT 8ATM. ALL FRAGMENTS WERE RETRIEVED FROM PATIENT. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE WHILE ADVANCING THE DEVICE. PHYSICIAN USED ANOTHER BALLOON TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10606682 ↗
• MalfunctionJul 14, 2017Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN USED THE PACIFIC PLUS TO PRE-DILATE A SEVERELY CALCIFIED LESION WITH LITTLE TORTUOSITY IN THE SUPERFICIAL FEMORAL ARTERY AS PER IFU. THE DEVICE WAS PREPPED AND LOADED WITH NO RESISTANCE ENCOUNTERED, OR EXCESSIVE FORCE USED ADVANCING THE BALLOON TO THE LESION. IT WAS REPORTED THE BALLOON RUPTURED WHEN FULLY OPENED ON FIRST INFLATION, AT 8ATMS 20 SECONDS AFTER INFLATION. ANOTHER DEVICE WAS USED TO COMPLETER THE PROCEDURE WITH NO FURTHER ISSUES NOTED. THE DEVICE WAS BEING USED FOR PRE DILATATION. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6713324 ↗