Pacific™ Plus PCP070060130Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033477054391), received between Jul 17, 2019 and Jul 17, 2019 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 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 17, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A HAWKONE H1-M DEVICE WITH A NON-MEDTRONIC 7FR SHEATH AND 0.014 NON-MEDTRONIC DEVICE DURING TREATMENT OF AN 80MM 90% STENOTIC FIBROUS, CALCIFIED LESION IN THE PATIENT¿S RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 7MM. SEVERE TORTUOSITY AND MODERATE CALCIFICATION WERE REPORTED. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE VESSEL WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. HOWEVER, THE HAWKONE WAS UNABLE TO REACH THE LESION. A NON-MEDTRONIC ATHERECTOMY DEVICE WAS USED TO TREAT THE LESION. THIS WAS FOLLOWED BY A 7X60 PACIFIC PLUS DEVICE. THE DEVICE WAS INFLATED TO 5ATM USING A NON-MEDTRONIC DEVICE BUT THE BALLOON BURST. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. A NON-MEDTRONIC BALLOON WAS USED TO TREAT THE COMMON FEMORAL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8798169 ↗