PACIFIC XTREME PCU060300130 (UDI 08033477075891)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08033477075891), received between Mar 24, 2020 and Feb 10, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN INTENDED TO USE A PACIFIC XTREME PTA BALLOON DURING TREATMENT OF A CALCIFIED AND FIBROUS LESION IN THE PATIENT¿S PROXIMAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT VESSEL TORTUOSITY AND SEVERE CALCIFICATION ARE REPORTED. THERE WAS NO DAMAGE 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 SPIDER FX EMBOLIC PROTECTION DEVICE AND NON-MEDTRONIC INFLATION DEVICE WERE USED FOR BALLOON INFLATION. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. IT IS REPORTED THE BALLOON PERFORMED WELL DURING FIRST INFLATION TO NOMINAL PRESSURE, HOWEVER A BURST OCCURRED DURING INFLATION WHEN THE BALLOON WAS SUBSEQUENTLY PULLED BACK TO DILATE A PROXIMAL AREA OF THE ARTERY AT 10ATM. THE DEVICE WAS REPLACED WITH ANOTHER PACIFIC XTREME TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11307467 ↗
• InjuryNov 19, 2020Deflation Problem; Fracture; Detachment of Device or Device Component; Deflation Problem; Fracture; Detachment of Device or Device Component

  PHYSICIAN USED A PACIFIC XTREME PTA BALLOON CATHETER ALONG WITH NON-MEDTRONIC 7FR SHEATH AND 0.014" 300CM GUIDEWIRE DURING PROCEDURE TO TREAT A LITTLE CALCIFIED PLAQUE LESION IN THE MID TO DISTAL POPLITEAL ARTERY. THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 100MM RESPECTIVELY. A MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. INFLATION FLUID USED WAS A CONTRAST 30% AND SALINE70% SOLUTION. 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 ISSUES IDENTIFIED. BALLOON DEFLATION DIFFICULTIES WAS REPORTED. THE DEFLATION ISSUE WAS NOTED DURING SUBSEQUENT INFLATION. DURING WITHDRAWAL BACK INTO SHEATH, THE CATHETER BROKE AND THE DETACHED PIECE WAS REMOVED WITH A SNARE. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. MORE BALLOONS AND STENTS WERE NEEDED TO COMPLETE THE PROCEDURE AS A RESULT OF THE BALLOON ISSUE. IT WAS REPORTED THAT THE BALLOON WAS USED TO PRE DILATE THE LESION BEFORE STENTING WITH A 6MM NON-MEDTRONIC STENT, THEN ALSO USED TO POST DILATE THE STENT. AFTER THE POST DILATION INFLATION, THE BALLOON WOULD NOT D

  Patient problems: Fistula; Vascular Dissection

  MAUDE report 10866197 ↗
• MalfunctionJun 23, 2020Deflation Problem; Inflation Problem; Material Twisted/Bent; Deflation Problem; Inflation Problem; Material Twisted/Bent

  PHYSICIAN WAS ATTEMPTING TO USE A PACIFIC XTREME PTA BALLOON CATHETER ALONG WITH A NON-MEDTRONIC 6FR SHEATH AND A 0.014 GUIDE CATHETER DURING PROCEDURE TO TREAT A LITTLE CALCIFIED PLAQUE LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 270MM RESPECTIVELY. THERE WAS NO DAMAGE TO PRODUCT PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS INSPECTED PER IFU WITH NO ISSUED IDENTIFIED. DURING BALLOON INFLATION, INFLATION DIFFICULTY WAS OBSERVED AT 4ATM. DURING BALLOON INFLATION, THE BALLOON WAS SLOW TO DEFLATE, WITH 40 SEC FOR BALLOON TO DEFLATE. BALLOON TWIST OCCURRED WITH REWRAP ISSUE NOTED. IT WAS REPORTED THAT PHYSICIAN CONTINUES TO HAVE PROBLEMS WITH THE 5 MM AND 6 MM 300MM BALLOONS TWISTING UPON INFLATION AND ARE EXTREMELY SLOW TO DEFLATE WHENEVER THIS TWISTING OCCURS. ANOTHER MEDTRONIC BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10183991 ↗
• MalfunctionMar 26, 2020Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  PHYSICIAN USED A PACIFIC XTREME PTA BALLOON WITH A NON-MEDTRONIC 6FR SHEATH AND 0.014 GUIDEWIRE DURING TREATMENT OF A >250MM PLAQUE LESION IN THE PATIENT¿S MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 6MM. MODERATE VESSEL CALCIFICATION IS REPORTED. NO DAMAGE NOTED TO PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED BALLOON INFLATION DIFFICULTIES WERE NOTED. THE BALLOON APPEARED TO BE STUCK TO THE CATHETER. A BALLOON TWIST IS REPORTED. PROCEDURE WAS COMPLETED WITH SAME BALLOON. THE PHYSICIAN ADVANCED TO AND INFLATED WHERE IT WAS STICKING TO CATHETER. NO VESSEL DAMAGE WAS NOTED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9881971 ↗
• MalfunctionMar 24, 2020Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9872503 ↗

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)