Pacific™ Plus PCP050120180Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033477080833), received between Apr 8, 2019 and Apr 8, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Burst Container or Vessel” (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.

• InjuryApr 8, 2019Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A PACIFIC PLUS PTA BALLOON TO TREAT A SEVERELY CALCIFIED, SLIGHTLY TORTUOUS LESION IN THE MID DISTAL LEFT SUPERFICIAL FEMORAL ARTERY(SFA). THE ARTERY DIAMETER AND LESION LENGTH WERE REPORTED TO BE 5MM & 120MM, RESPECTIVELY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE TRAY/HOOP. THE DEVICE WAS PREPPED WITHOUT ISSUE. A 6FR SHEATH AND A NON-MEDTRONIC GUIDEWIRE WERE USED WITH NO EMBOLIC PROTECTION. THE DEVICE WAS INFLATED WITH AN INFLATION DEVICE. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT BUT NO RESISTANCE WAS ENCOUNTERED NOR EXCESSIVE FORCE USED ON ADVANCING THE DEVICE TO THE TARGET LESION. THE PACIFIC PLUS PTA BALLOON IS REPORTED TO HAVE RUPTURED ON POST DILATION OF THE STENT. REMOVAL DIFFICULTIES WERE REPORTED FOLLOWING THE BALLOON INFLATION. THE BALLOON WAS REMOVED VIA A CUT DOWN ON THE PTA. THE PATIENT WAS TRANSFERRED TO RECOVERY AND IS REPORTED TO BE DOING WELL. A CT SCAN IS PLANNED FOR THE PATIENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8491482 ↗