Pacific PlusRecalls & reported problems across all models

We found 25 models of Pacific Plus by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between Jul 14, 2017 and Mar 3, 2026 — classified as 7 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (12 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Pacific Plus problems

Pacific Plus models

25 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Pacific™ Plus PCP050120130

  Catheter, angioplasty, peripheral, transluminal
  2 reports
• Pacific™ Plus PCP020040150

  Catheter, angioplasty, peripheral, transluminal
  2 reports
• Pacific™ Plus PCP060300150

  Catheter, angioplasty, peripheral, transluminal
  2 reports
• Pacific™ Plus PCP070040130

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Pacific™ Plus PCP070060130

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Pacific™ Plus PCP060120130

  CATHETER, PERCUTANEOUS
  1 report
• Pacific™ Plus PCP025120130

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Pacific™ Plus PCP030020180

  CATHETER, PERCUTANEOUS
  1 report
• Pacific™ Plus PCP030150130

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Pacific™ Plus PCP035060130

  CATHETER, PERCUTANEOUS
  1 report
• Pacific™ Plus PCP020120180

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Pacific™ Plus PCP025080150

  CATHETER, PERCUTANEOUS
  1 report
• Pacific™ Plus PCP030120150

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Pacific™ Plus PCP020150150

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Pacific™ Plus PCP060250150

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Pacific™ Plus PCP040300150

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Pacific™ Plus PCP040020090

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Pacific™ Plus PCP040100150

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Pacific™ Plus PCP040150150

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Pacific™ Plus PCP060200150

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Pacific™ Plus PCP070040150

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Pacific™ Plus PCP070100150

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Pacific™ Plus PCP040200200

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Pacific™ Plus PCP030040130

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Pacific™ Plus PCP050120180

  Catheter, percutaneous
  1 report

Recent Pacific Plus adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Leak/Splash

  A PHYSICIAN ATTEMPTED TO USE A (B (4) PACIFIC PLUS PTA BALLOON TO TREAT A CALCIFIED LESION IN A PATIENT. THE BALLOON WAS SUCCESSFULLY PREPPED, INSERTED, INFLATED, DEFLATED, AND REMOVED ONCE WITH NO ISSUE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. WHEN ATTEMPTING TO FLUSH TO PREPARE FOR A SECOND INSERTION <(>&<)> USE, THE SALINE SOLUTION WAS INJECTED INTO THE APPROPRIATE PORT TO FLUSH THE CATHETER LUMEN, THE SOLUTION CAME OUT THE BALLOON PORT INSTEAD. THE BALLOON WAS NOT USED AFTER THIS DISCOVERY. IT WAS NOTED THAT THE VESSEL WAS HEAVILY CALCIFIED, AND THAT THERE WERE OTHER UNKNOWN DEVICES USED THROUGHOUT THE PROCEDURE (SUCH AS WIRES/CATHETERS) THAT HAD BECOME KINKED WITH NORMAL USE, BUT IT WAS UNCLEAR IF THAT WAS THE CAUSE OF THE ISSUE OR IF THERE WAS A DEFECT IN THE BALLOON. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24495722 ↗
• MalfunctionFeb 3, 2026Burst Container or Vessel

  IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED LESION IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY USING THE PACIFIC PLUS, THE BALLOON EXHIBITED A PIN HOLE BURST AT 6 ATM PRESSURE ON THE FIRST INFLATION. THE LESION WAS CHARACTERISED BY SEVERE CALCIFICATION, 60-80% STENOSIS, A LENGTH OF 200 MM, AND AN ARTERY DIAMETER OF 6.2-5.8 MM. THE PROCEDURE UTILIZED A 6FR NON MEDTRONIC SHEATH, SPIDER WIRE GUIDEWIRE, AND SPIDER EMBOLIC PROTECTION. THE VESSEL WAS NOT PRE-DILATED BUT WAS POST-DILATED WITH A NON MEDTRONIC DEVICE. INFLATION WAS PERFORMED WITH A NON MEDTRONIC INFLATION DEVICE USING 50/50 CONTRAST FLUID. THERE WAS NO RESISTANCE ENCOUNTERED DURING DEVICE ADVANCEMENT, AND THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. THE BALLOON DID NOT DETACH, AND THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW PACIFIC PLUS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247058 ↗
• MalfunctionJan 19, 2026Material Twisted/Bent

  IT WAS REPORTED THAT DURING A POST-DILATION BALLOON PROCEDURE, WHICH WAS THE FINAL STEP OF TREATMENT FOR PLAQUE IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY (PERIPHERAL ARTERY DISEASE), A BALLOON TWIST/DOG-BONE TWIST WAS VISIBLE WITHIN THE BALLOON IN THE VESSEL USING A PACIFIC PLUS US CATHETER. THE ARTERY DIAMETER WAS 6 MILLIMETERS AND THE DEGREE OF TORTUOSITY WAS MINIMAL. EMBOLIC PROTECTION WAS USED WITH A SPIDERFX DEVICE. THE BALLOON WAS INFLATED WITH A 50/50 CONTRAST SOLUTION USING AN INFLATION DEVICE. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24108659 ↗
• MalfunctionNov 20, 2025Deflation Problem; Difficult to Insert; Deflation Problem; Difficult to Insert

  IT WAS REPORTED THAT THERE WAS DIFFICULTY INSERTING THE CATHETER AND THE PACIFIC PLUS WAS SLOW TO DEFLATE. THE SHEATH USED WAS A 6FR NON MEDTRONIC DEVICE, AND THE VESSEL WAS PRE-DILATED WITH A MEDTRONIC PACIFIC PLUS DEVICE. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. THE DEVICE WAS SAFELY REMOVED, AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO DAMAGE WAS NOTED TO THE BALLOON CATHETER. THE BALLOON WAS INFLATED USING A INFLATIONS DEVICE AND NO ISSUES WERE NOTED DURING INFLATION. CONTRAST/SALINE INFLATION FLUID WAS USED (% UNKNOWN). THE BALLOON WAS EVENTUALLY FULLY DEFLATED FOR REMOVAL NORMALLY, THE ISSUE WAS THE BALLOON WAS NOT ABLE TO BE RE-INSERTED FOR A 2ND TIME. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606383 ↗
• MalfunctionSep 8, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING A PERIPHERAL ARTERY INTERVENTION INVOLVING THE CATHETER PACIFIC PLUS BALLOON, A PATIENT WAS TREATED FOR A CALCIFIED LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE TARGET LESION EXHIBITED 100% STENOSIS, MEASURED 150 MM IN LENGTH, AND HAD A MODERATE DEGREE OF CALCIFICATION. INFLATION DIFFICULTIES WERE ENCOUNTERED WITH THE REPORTED CATHETER DEVICE, AND A LEAK WAS NOTED ON THE SHAFT. THE DEVICE FUNCTIONED DURING VESSEL PREPARATION BUT WOULD NOT INFLATE TO POST-DILATE AFTER STENT PLACEMENT (MEDTRONIC EVERFLEX PRB35-06-200-120 AND MEDTRONIC EVERFLEX EVD35-06-150-120). THE VESSEL WAS PRE-DILATED USING THE SAME DEVICE AND POST-DILATED WITH A MEDTRONIC ADMIRAL XTREME 6 X 250 X 130 CM AFTER THE REPORTED DEVICE FAILED TO INFLATE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THERE WAS NO DAMAGE NOTED TO THE STENTS. THE PHYSICIAN EXPERIENCE A LOT OF RESISTANCE THROUGHOUT THE PROCEDURE PARTICULARLY WHEN WITHDRAWING THE BALLOON FROM THE PATIENT INTO THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22991589 ↗
• MalfunctionJul 9, 2025Difficult to Remove; Defective Component; Difficult to Advance; Difficult to Remove; Defective Component; Difficult to Advance

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE CATHETER PACIFIC PLUS, LOSS OF WIRE ACCESS OCCURRED WHEN THE GUIDEWIRE BECAME STUCK IN THE BALLOON WHILE TREATING A MODERATE, CALCIFIED LESION IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY. HAD TO ABORT BALLOONING, AND ACCESS ACROSS THE LESION HAD TO BE RE-ESTABLISHED. A NEW PACIFIC PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER (4MMX200MMX200MM) WAS USED TO COMPLETE THE PROCEDURE. THE RADIOPAQUE BALLOON MARKERS WERE REPORTEDLY MARKED INCORRECTLY, WITH DOUBLE MIDDLE MARKERS IN THE WRONG POSITION. TRACKING DIFFICULTY WAS NOTED DURING INITIAL ADVANCEMENT DUE TO AN ANCILLARY DEVICE, AND AFTER INFLATION, THERE WAS DIFFICULTY REMOVING THE BALLOON BECAUSE THE 0.018 GUIDEWIRE WAS STUCK INSIDE. THE BALLOON WAS SUCCESSFULLY REMOVED IN TANDEM WITHOUT INJURY OR INTERVENTION, AND THERE WAS NO VESSEL DAMAGE. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE, AND THE VESSEL WAS POST-DILATED WITH 50/50 CONTRAST AS THE INFLATION FLUID. NO ABNORMALITIES WERE REPORTED IN RELATION TO ANATOMY, AND THE DEGREE OF TORTUOSITY WAS MINIMAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459872 ↗
• MalfunctionMay 27, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE CATHETER PCP040300150 PACIFIC PLUS US D4L300UL1500, A BALLOON BURST OCCURRED ON THE FIRST INFLATION. A 7X45 NON-MEDTRONIC SHEATH AND A 014X300CM NITREX GUIDEWIRE WERE USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 CONTRAST. EMBOLIC PROTECTION WAS NOT USED AND THE VESSEL WAS NOT PRE-OR POST-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE EVENT TOOK PLACE IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY, WHICH WERE IDENTIFIED AS CALCIFIED TARGET LESIONS. THE BALLOON BURST WAS NOTED DURING THE PROCEDURE, THE TYPE OF BALLOON BURST AND PRESSURE IT BURST AT IS UNKNOWN. THE BALLOON DID NOT DETACH DURING THE EVENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT AND THERE WAS NO INJURY/INTERVENTION ASSOCIATED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE, SPECIFICALLY A TURBOHAWK PLUS LX. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087141 ↗
• InjuryMar 10, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A PACIFIC PLUS, THERE WERE DEFLATION DIFFICULTIES WITH THE BALLOON CATHETER IN THE RIGHT MID COMMON FEMORAL ARTERY. THE TARGET LESION WAS IDENTIFIED AS CALCIFIED WITH MODERATE CALCIFICATION AND TORTUOSITY. ARTERY DIAMETER REPORTED AS 6-7MM AND LESION DIAMETER REPORTED AS 80MM. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 CONTRAST. THE PATIENT EXPERIENCED A 15-MINUTE DELAY IN SURGERY DUE TO THE PRODUCT MALFUNCTION. THE BALLOON WAS EVENTUALLY DEFLATED MANUALLY WITH A NEEDLE STICK AFTER 15 MINUTES OF NEGATIVE PRESSURE, USING ULTRASOUND GUIDANCE INTO THE RIGHT GROIN WHERE THE BALLOON WAS STUCK INFLATED. THE PROCEDURE WAS COMPLETED USING A NEW 7X80 IN.PACT 018 DRUG COATED BALLOON. THE PATIENT RECOVERED AND WAS EXPOSED TO UNNECESSARY RISK ASSOCIATED WITH ADDITIONAL VESSEL TRAUMA. NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558019 ↗
• MalfunctionFeb 6, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A CO2 ANGIOGRAM OF THE RIGHT LEG, DIFFUSE DISEASE WAS OBSERVED THROUGHOUT THE ENTIRE RIGHT ANTERIOR TIBIAL ARTERY. THE LESION LENGTH WAS 250MM AND THE TARGET LESION WAS PLAQUE. LESION STENOSIS WAS 60-70%. THERE WAS MINIMAL TORTUOSITY AND CALCIFICATION. THE ARTERY WAS 3MM IN DIAMETER.  A PACIFIC PLUS BALLOON WAS USED FOR A THREE-SEGMENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (DISTAL, MIDDLE, PROXIMAL). AFTER THE INITIAL PROCEDURE, A FOLLOW-UP CO2 ANGIOGRAM SHOWED MINIMALLY IMPROVED FLOW, PROMPTING A REPEAT OF THE ANGIOPLASTY. DURING THE PROCEDURE, DIFFICULTY WAS ENCOUNTERED WHEN ATTEMPTING TO BACK OUT THE BALLOON OVER THE WIRE, AS IT KEPT GETTING CAUGHT. THE BALLOON WAS FULLY DEFLATED, THE BALLOON CATHETER WAS FLUSHED, AND THE WIRE WAS WET. THE WIRE WAS CHANGED BUT DESPITE USING A NEW WIRE, THE ISSUE PERSISTED. PTA WAS THEN DONE ON THE PROXIMAL SEGMENT OF THE RIGHT ANTERIOR TIBIAL ARTERY. WHEN THAT WAS DONE, AND THE BALLOON WAS FULLY DEFLATED, THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE BALLOON OVER THE WIRE AGAIN, AND EVEN WITH GREAT FORCE WAS UNABLE TO BACK THE BALLOON OUT. THE PHYSICIAN ULTIMATELY REMOVED BOTH THE WIRE AND THE BALLOON TOGETHER, RISKING L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322240 ↗
• MalfunctionJan 16, 2025Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT THERE WERE DEFLATION AND INFLATION DIFFICULTIES WITH THE CATHETER PACIFIC PLUS  DURING A PROCEDURE INVOLVING THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE BALLOON TOOK LONGER THAN USUAL TO DEFLATE AND WAS REPOSITIONED AND RE-INFLATED WITH SOME DIFFICULTY. THE BALLOON WAS EVENTUALLY FULLY DEFLATED FOR REMOVAL AFTER WAITING FOR IT TO DEFLATE ON ITS OWN. THE PROCEDURE WAS COMPLETED AFTER THE SECOND DEFLATION WAS COMPLETED. THERE WERE NO HEALTH CONSEQUENCES OR IMPACT ON THE PATIENT, AND THE DEVICE WAS SAFELY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21166105 ↗
• MalfunctionDec 11, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A CATHETER PACIFIC PLUS BALLOON FOR TREATMENT IN THE PEDAL ARTERY THE BALLOON BURST DURING THE PROCEDURE, AND SUBSEQUENTLY DETACHED. A PORTION OF THE DEVICE REMAINED IN THE PATIENT. DISTAL EMBOLIZATION WAS ALSO REPORTED FOR THE DETACHED PIECE OF THE BALLOON. THE DETACHED PORTION OF THE DEVICE WAS LEFT IN THE PATIENT WITHOUT INTERVENTION, AND NO INTERVENTION IS PLANNED TO REMOVE THE DETACHED PIECE OF THE BALLOON.

  Patient problems: Embolism/Embolus

  MAUDE report 20901578 ↗
• InjuryNov 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A 2.5X60MM PACIFIC PLUS PTA BALLOON DURING TREATMENT OF THE PATIENT¿S COMMON ILIAC VEIN (CIV) & EXTERNAL ILIAC VEIN (EIV). THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. AN INFLATION DEVICE WAS USED. 50/50 CONTRAST INFLATIONFLUID WAS USED. TRACKING DIFFICULTY DURING INITIAL ADVANCEMENT WAS REPORTED. MODERATE RESISTANCE WAS NOTED, OTHER BALLOON (BARD ATLAS) WAS UNABLE TO CROSS THE LESION. IT WAS REPORTED THAT THE 2.5X60MM PACIFIC PLUS BALLOON GOT STUCK ON AN 018 NON-MEDTRONIC WIRE AND WAS SAFELY REMOVED WITH THE WIRE FROM THE PATIENT. THE PHYSICIAN THEN ATTEMPTED TO USE A 7X40MM PACIFIC PLUS PTA BALLOON. IT WAS REPORTED THAT THE 7X40MM PACIFIC PLUS GOT STUCK AND DETACHED AT THE TARGET LESION AS THEY TRIED TO REMOVE IT. ONLY A PARTIAL PIECE OF THE BALLOON WAS REMOVED. THE DETACHED COMPONENT WAS LEFT IN THE PATIENT. PHYSICIAN THEN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON TO PULL OUT THE DETACHED 7X40MM PACIFIC PLUS BUT THE NANOCROSS ELITE ALSO GOT STUCK AND DETACHED, THE NANOCROSS WAS REMOVED WITH A SNARE. THE DETACHED NANOCROSS ELITE WAS REMOVED FROM THE PATIENT. PROCEDURE WAS ABORTED. THE PATIENT MAY NEED SURGICAL INTERVENTION TO REMOVE T

  Patient problems: Foreign Body In Patient

  MAUDE report 20706732 ↗
• InjurySep 5, 2024Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A PACIFIC PLUS PTA BALLOON WITH A 45CM 6FR NON-MEDTRONIC SHEATH AND A NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S LEFT PROXIMAL MID RENAL ARTERY. MINIMAL VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION WERE REPORTED. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS PRE-DILATED WITH A PACIFIC PLUS PTA BALLOON. THE VESSEL WAS NOT POST-DILATED. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. 50/50 CONTRAST FLUID WAS USED. THE BALLOON WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. MINIMAL RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THE BALLOON BURST/DETACHED AT THE TARGET LESION. A SNARE WAS USED TO REMOVE THE DETACHED COMPONENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS ABORTED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20143912 ↗
• InjuryAug 22, 2024Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A PACIFIC PLUS PTA BALLOON DURING PERCUTANEOUS BALLOONING OF THE PATIENTS SUBCLAVIAN VEIN. THE ATTENDING PHYSICIAN INSERTED AND INFLATED THE PACIFIC PLUS .018 BALLOON, WHICH RUPTURED. THE PHYSICIAN REMOVED THE BALLOON CATHETER AND OBSERVED THAT THE TIP WAS MISSING. UNDER FLUOROSCOPY IT WAS CONFIRMED THAT THE RADIOPAQUE BAND FROM THE TIP OF THE BALLOON WAS RETAINED IN THE PATIENT. MULTIPLE ATTEMPTS WERE MADE WITH SNARES TO RETRIEVE THE BALLOON REMNANT, BUT THE TEAM WAS UNABLE TO RETRIEVE. PATIENT REMAINED STABLE THROUGHOUT PROCEDURE AND NO PATIENT HARM WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20039976 ↗
• MalfunctionMay 20, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  PHYSICIAN ATTEMPTED TO USE A PACIFIC PLUS PTA BALLOON WITH A 6X45 NON-MEDTRONIC (TERUMO DESTINATION) SHEATH AND A .018 NON-MEDTRONIC (ABBOTT COMMAND) GUIDEWIRE DURING TREATMENT OF AN 80MM CALCIFIED LESION IN THE PATIENT¿S LEFT DISTAL ANTERIOR TIBIAL ARTERY. MODERATE VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED 70% STENOSIS. ARTERY DIAMETER REPORTED AS 2.5MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT PRE OR POST DILATED. A NON-MEDTRONIC (BOSTON SCIENTIFIC ENCORE) INFLATION DEVICE WAS USED FOR BALLOON INFLATION. 50/50 CONTRAST FLUID WAS USED. THE BALLOON WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. SEVERE RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. INFLATION DIFFICULTIES WERE REPORTED. THE BALLOON WOULDN¿T MAINTAIN PRESSURE. NO LEAKS WERE NOTED ON THE DEVICE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT AND THE PROCEDURE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19349938 ↗

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