Pacific™ Plus PCP060120130Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033477054902), received between Jul 25, 2017 and Jul 25, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionJul 25, 2017Inflation Problem; Difficult to Remove; Detachment of Device or Device Component; Inflation Problem; Difficult to Remove; Detachment of Device or Device Component

  THE PHYSICIAN INTENDED TO USE A PACIFIC PLUS DURING PROCEDURE FOR TREATMENT OF THE MID COMMON ILIAC ARTERY. THE FIBROUS LESION EXHIBITED LITTLE TORTUOSITY, NO CALCIFICATION WITH 70% STENOSIS. ARTERY DIAMETER IS REPORTED TO BE 7MM WITH A LESION LENGTH OF 120MM. IT IS REPORTED THAT THE PATIENT HAD A TUMOR THAT COMPRESSED THE ARTERY. THE BALLOON WAS INFLATED USING A NON-MEDTRONIC INFLATION DEVICE, AND 50/50 CONTRAST/SALINE WAS USED. THERE WAS NO DAMAGE TO THE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED WITH NO ISSUES IDENTIFIED. IT IS REPORTED THAT BALLOON INFLATION DIFFICULTIES OCCURRED. THE EVENT WAS NOT OBSERVED DURING BALLOON INFLATION. IT IS REPORTED THAT 2ND INFLATION WAS UNSUCCESSFUL. WHEN NEGATIVE WAS PULLED ON THE DEVICE, BLOOD WAS PRESENT IN THE INFLATOR. THE PHYSICIAN REMOVED THE BALLOON AND OBSERVED THE BALLOON WAS NO LONGER ON THE CATHETER. THE PHYSICIAN IMAGED THE ANATOMY AND FOUND THE BALLOON SLEEVE INSIDE THE SHEATH. THE PHYSICIAN WAS ABLE TO REMOVE THE SHEATH AND MAINTAIN WIRE ACCESS TO REMOVE THE BALLOON PIECE. IT IS REPORTED THAT 4 ATM WAS APPLIED WHEN IT WAS DETERMINED THAT THERE WAS INFLATION DIFFICULTI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6742377 ↗