PACIFIC XTREME PCU060200130 (UDI 08033477075853)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08033477075853), received between Aug 20, 2020 and Sep 21, 2020 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2020Material Deformation; Material Deformation

  PHYSICIAN INTENDED TO USE A PACIFIC XTREME PTA BALLOON DURING TREATMENT OF A PLAQUE CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL CALCIFICATION IS REPORTED. A 7FR NON-MEDTRONIC SHEATH AND SPIDER FX EMBOLIC PROTECTION DEVICE WERE USED. A NON-MEDTRONIC INFLATION DEVICE AS USED FOR BALLOON INFLATION. 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. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT FOR POST-DILATION OF THE DEPLOYED COVERED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. A BALLOON TWIST IS REPORTED. DURING INFLATION THERE WAS AN AREA OF THE BALLOON THAT WAS NOT INFLATING, LOOKED TO BE PINCHED. PHYSICIAN THEN PULLED BALLOON BACK TO PUT IN DIFFERENT AREA OF THE STENT AND THE SAME THING WAS NOTED IN THE SAME SPOT OF THE BALLOON. A REWRAP TOOL WAS NOT USED. IT IS REPORTED THE BALLOON WAS ADJUSTED SO THAT THE TWISTED AREA WAS NOT IN THE SAME SPOT TWICE DURING INFLATION. NO PATIENT INJURY REPORTED.

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

  MAUDE report 10559281 ↗
• MalfunctionSep 10, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN INTENDED TO USE A TURBOHAWK ATHERECTOMY DEVICE AND PACIFIC XTREME PTA BALLOON WITH A 7FR NON-MEDTRONIC SHEATH AND 0.014 NITREX GUIDEWIRE DURING TREATMENT OF A 20CM CALCIFIED LESION IN THE PATIENT¿S DISTAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA). VESSEL DIAMETER REPORTED AS 6MM. SLIGHT VESSEL TORTUOSITY AND SEVERE CALCIFICATION ARE REPORTED. LESION EXHIBITED 90% STENOSIS. NO DAMAGE WAS NOTED TO THE PRODUCTS PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICES FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND BOTH THE TURBOHAWK AND PACIFIC XTREME DEVICES WERE PREPPED WITHOUT ISSUE. IT IS REPORTED THE HAWKONE ATHERECTOMY DEVICE WAS USED INITIALLY. AFTER COMPLETING 3 PASSES IT IS REPORTED THE DEVICE WOULD NOT CLOSE COMPLETELY. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PACIFIC XTREME PTA BALLOON WAS USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH A 50/50 CONTRAST AND SALINE MIX FOR BALLOON INFLATION. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. IT IS REPORTED THAT A PINHOLE BALLOON BURST OCCURRED AT A PRESSURE OF ATM ON 4TH INFLATION OF THE DEVICE. IT WAS DETERMINED THAT THE INFLATION WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10513461 ↗
• MalfunctionSep 7, 2020Material Twisted/Bent; Material Twisted/Bent

  PHYSICIAN INTENDED TO USE A PACIFIC XTREME DEVICE DURING PATIENT TREATMENT. 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. IT IS REPORTED DURING THE PROCEDURE THE BALLOON TWISTED MIDSHAFT AND CREATED A WAIST. THE SAME ISSUE IS REPORTED FOR A SECOND PACIFIC XTREME DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10498635 ↗
• MalfunctionSep 7, 2020Material Twisted/Bent; Material Twisted/Bent

  PHYSICIAN INTENDED TO USE A PACIFIC XTREME DEVICE DURING PATIENT TREATMENT. 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. IT IS REPORTED DURING THE PROCEDURE THE BALLOON TWISTED MIDSHAFT AND CREATED A WAIST. THE SAME ISSUE IS REPORTED FOR A SECOND PACIFIC XTREME DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10498634 ↗
• MalfunctionAug 20, 2020Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  PHYSICIAN WAS ATTEMPTING TO USE A PACIFIC XTREME PTA BALLOON ALONG WITH A NON-MEDTRONIC 7FR SHEATH DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE PROXIMAL, MID AND DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 75% STENOSIS. THE VESSEL IS LITTLE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 300MM RESPECTIVELY. AN INFLATION DEVICE WAS USED TO INFLATE THE BALLOON. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. BALLOON INFLATION DIFFICULTIES WAS OBSERVED DURING BALLOON INFLATION. IT WAS REPORTED THAT BALLOON TWIST AT 14ATM WITH A REWRAP ISSUE NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE WHILE ADVANCING THE DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10429701 ↗

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)