PACIFIC XTREME PCU050300130 (UDI 08033477076102)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08033477076102), received between Jun 2, 2020 and Apr 27, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K103464); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2022Deflation Problem; Inflation Problem; Difficult to Remove; Material Twisted/Bent; Deflation Problem; Inflation Problem; Difficult to Remove; Material Twisted/Bent

  PHYSICIAN WAS ATTEMPTING TO USE THE PACIFIC XTREME BALLOON DURING PROCEDURE TO TREAT MODERATELY CALCIFIED LESION IN THE DISTAL MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL HAD LITTLE TORTUOSITY. THE ARTERY DIAMETER WAS 5MM AND LESION LENGTH WAS 300MM. THE BALLOON WAS INFLATED WITH AN INFLATION DEVICE. HALF CONTRAST HALF SALINE INFLATION FLUID WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. IT WAS REPORTED THAT THERE WERE BALLOON INFLATION DIFFICULTIES AT 6AM. IT WAS REPORTED THAT THERE WAS A BALLOON WRAP. A REWRAP ISSUE WAS NOT NOTED. BALLOON WAS PLACED IN DISTAL SFA AND INFLATED, TWIST WAS RECOGNIZED AND BALLOON WAS DEFLATED. CONTRAST WOULD NOT COME OUT OF DISTAL PORTION OF BALLOON DUE TO THE WRAP SO PHYSICIAN HAD TO PULL BALLOON BACK ACROSS LESION TO DEFLATE  THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14216767 ↗
• InjuryDec 18, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  PHYSICIAN USED PACIFIC XTREME PTA BALLOON TO TREAT A CHRONIC TOTAL OCCLUSION (CTO-100%) LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION LENGTH WAS 10CM. THERE WAS NO DAMAGE NOTED TO 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 THE DEVICE WAS USED TO BALLOON ANGIOPLASTY THE LEFT SFA. WHEN THE BALLOON WAS DEFLATED, PATIENT'S BLOOD PRESSURE DROPPED TO ZERO AND CHEST COMPRESSIONS WERE REPORTEDLY PERFORMED. DOPAMINE WAS PROVIDED ON SITE. IT WAS POSTULATED THAT PATIENT HAD AN ALLERGIC/ANAPHYLACTIC REACTION TO THE DEVICE. PATIENT HAD A HISTORY OF THIS HAPPENING ONCE BEFORE DURING A PREVIOUS INTERVENTION ON THE CONTRALATERAL SIDE (RIGHT SIDE) AT AN UNKNOWN DATE. AT THAT TIME, IT WAS POSTULATED THAT IT MAY HAVE BEEN DUE TO MEDICATION OR HAVING A POSSIBLE LATEX ALLERGY. DURING INTERVENTION, FENTANYL WAS NOT USED AND PHYSICIAN CAREFULLY MONITORED VITALS EVERY STEP OF THE WAY AS REPORTED. THE PATIENT REPORTEDLY RECOVERED ON SITE WITH PATIENT'S BLOOD PRESSURE AT 80/40. NO FURTHER INJURY REPORTED.

  Patient problems: Anaphylactic Shock; Low Blood Pressure/ Hypotension

  MAUDE report 11035269 ↗
• MalfunctionOct 20, 2020Material Twisted/Bent; Material Twisted/Bent

  PHYSICIAN INTENDED TO USE A PACIFIC XTREME PTA BALLOON WITH A 7FR NON-MEDTRONIC SHEATH DURING TREATMENT OF A 300MM CALCIFIED LESION IN THE PATIENT¿S MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). SEVERE VESSEL CALCIFICATION IS REPORTED. NO VESSEL TORTUOSITY REPORTED. ARTERY DIAMETER REPORTED AS 5MM. LESION EXHIBITED 90% STENOSIS. NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. IT IS REPORTED THE BALLOON FAILED TO UNWRAP PROPERLY DURING INFLATION RESULTING IN A TWIST IN THE MIDDLE OF THE BALLOON AT AN INFLATION PRESSURE OF 14ATM. A REWRAP ISSUE WAS NOT NOTED. A REWRAP TOOL WAS NOT USED. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

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

  MAUDE report 10703675 ↗
• MalfunctionJun 2, 2020Material Twisted/Bent; Material Twisted/Bent

  PHYSICIAN WAS ATTEMPTING TO USE A PACIFIC XTREME PTA BALLOON CATHETER DURING PROCEDURE. THERE WAS NO DAMAGE TO DEVICE PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. BALLOON INFLATION DIFFICULTY OCCURRED. IT WAS REPORTED THAT DURING BALLOON INFLATION, BALLOON WRAP OCCURRED AND THE BALLOON DID NOT INFLATE IN CENTER. THE VESSEL WAS NOT PRE DILATED. THE DEVICE DID NOT PASS THROUGH PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10107875 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103464. One submission often covers many models, so check the product and lot details in each record.

• Z-3055-2020 · Aug 26, 2020 · Terminated
  Pacific Xtreme (PTCA Balloon Dilation Catheter)