PACIFIC XTREMERecalls & reported problems across all models

We found 25 models of PACIFIC XTREME by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 55 adverse event reports in the FDA's MAUDE database, received between Jan 4, 2017 and Jul 3, 2023 — classified as 5 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (21 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 XTREME problems

PACIFIC XTREME models

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

• PACIFIC XTREME PCU060150130

  Catheter, angioplasty, peripheral, transluminal
  6 reports
• PACIFIC XTREME PCU060200130

  Catheter, angioplasty, peripheral, transluminal
  5 reports
• PACIFIC XTREME PCU060300130

  Catheter, percutaneous
  5 reports
• PACIFIC XTREME PCU050300130

  Catheter, angioplasty, peripheral, transluminal
  4 reports
• PACIFIC XTREME PCU050300130

  CATHETER, PERCUTANEOUS
  3 reports
• PACIFIC XTREME PCU060250130

  Catheter, percutaneous
  3 reports
• PACIFIC XTREME PCU070200130

  Catheter, percutaneous
  3 reports
• PACIFIC XTREME PCU050200130

  Catheter, percutaneous
  3 reports
• PACIFIC XTREME PCU050250130

  Catheter, angioplasty, peripheral, transluminal
  2 reports
• PACIFIC XTREME PCU050300130

  Catheter, angioplasty, peripheral, transluminal
  2 reports
• PACIFIC XTREME PCU050200130

  CATHETER, PERCUTANEOUS
  2 reports
• PACIFIC XTREME PCU040150130

  Catheter, angioplasty, peripheral, transluminal
  2 reports
• PACIFIC XTREME PCU040200130

  Catheter, percutaneous
  2 reports
• PACIFIC XTREME PCU050150130

  Catheter, angioplasty, peripheral, transluminal
  2 reports
• PACIFIC XTREME PCU060200130

  Catheter, angioplasty, peripheral, transluminal
  1 report
• PACIFIC XTREME PCU070200130

  CATHETER, PERCUTANEOUS
  1 report
• PACIFIC XTREME PCU050150130

  Catheter, angioplasty, peripheral, transluminal
  1 report
• PACIFIC XTREME PCU060150130

  CATHETER, PERCUTANEOUS
  1 report
• PACIFIC XTREME PCU060200130

  CATHETER, PERCUTANEOUS
  1 report
• PACIFIC XTREME PCU060300130

  Catheter, angioplasty, peripheral, transluminal
  1 report
• PACIFIC XTREME PCU070200130

  Catheter, angioplasty, peripheral, transluminal
  1 report
• PACIFIC XTREME PCU040250130

  Catheter, angioplasty, peripheral, transluminal
  1 report
• PACIFIC XTREME PCU040300130

  Catheter, angioplasty, peripheral, transluminal
  1 report
• PACIFIC XTREME PCU070150130

  Catheter, percutaneous
  1 report
• PACIFIC XTREME PCU070250130

  Catheter, angioplasty, peripheral, transluminal
  1 report

Recent PACIFIC XTREME adverse event reports

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

• MalfunctionJul 3, 2023Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN WAS ATTEMPTING TO USE A PACIFIC XTREME DURING TREATMENT OF A 150MM CALCIFIED PLAQUE LESION WITH 90% STENOSIS OF THE MID RIGHT SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS 6MM IN DIAMETER WITH MODERATE CALCIFICATION AND NO TORTUOSITY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. A 6FR NON MEDTRONIC SHEATH AND NON MEDTRONIC GUIDEWIRE WERE USED. THE BALLOON WAS INFLATED WITH 50/50 CONTRAST. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE USED. IT WAS REPORTED BALLOON INFLATION DIFFICULTIES WERE ENCOUNTERED AND AT NOMINAL BALLOON PRESSURE (NBP) BALLOON TWIST WAS OBSERVED. A REWRAP TOOL WAS NOT USED. THE PROCEDURE WAS COMPLETED WITH NO ISSUES. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17245832 ↗
• MalfunctionNov 14, 2022Burst Container or Vessel; Burst Container or Vessel

  A PHYSICIAN WAS ATTEMPTING TO USE TWO PACIFIC XTREME PTA BALLOON DILATATION CATHETER DURING TREATMENT OF A CALCIFIED LESION WITH 80% STENOSIS IN THE MID REGION OF THE SUPERFICIAL FEMORAL ARTERY. THE DEVICES WERE PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. A NON-MDT INFLATION DEVICE WAS USED, AND CONTRAST HEP SALINE WAS USED DURING INFLATION. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLYDEPLOYED STENT, RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES, EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT BOTH BALLOONS BURST AT 4 ATM. A NON-MEDTRONIC NEW BALLOON WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15789704 ↗
• MalfunctionNov 14, 2022Burst Container or Vessel; Burst Container or Vessel

  A PHYSICIAN WAS ATTEMPTING TO USE TWO PACIFIC XTREME PTA BALLOON DILATATION CATHETER DURING TREATMENT OF A CALCIFIED LESION WITH 80% STENOSIS IN THE MID REGION OF THE SUPERFICIAL FEMORAL ARTERY. THE DEVICES WERE PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. A NON-MDT INFLATION DEVICE WAS USED, AND CONTRAST HEP SALINE WAS USED DURING INFLATION. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLYDEPLOYED STENT, RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES, EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT BOTH BALLOONS BURST AT 4 ATM. A NON-MEDTRONIC NEW BALLOON WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15789654 ↗
• 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 ↗
• MalfunctionMar 21, 2022Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS ELITE AND PACIFIC XTREME PTA BALLOON CATHETERS DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE PROXIMAL POPLITEAL ARTERY (POP). THE VESSEL WAS A LITTLE TORTUOUS. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATIOON. 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. IT WAS REPORTED THAT DURING BALLOON INFLATION, BALLOON BURST/LEAK/RUPTURE OCCURRED AT 8ATM. ALL FRAGMENTS OF THE NANOCROSS BALLOON WERE RETRIEVED. PHYSICIAN REPLACED WITH A PACIFIC XTREME AND SAME THING OCCURRED. BALLOON RUPTURE OCCURRED AT 8ATM. ALL FRAGMENTS OF THE PACIFIC XTREME BALLOON WERE ALSO RETRIEVED. PROCEDURE WAS COMPLETED AFTER SECOND BALLOON RUPTURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13838706 ↗
• MalfunctionNov 10, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE A PACIFIC XTREME PTA BALLOON WITH A 6FRENCH 45CM NON-MEDTRONIC SHEATH AND 6MM SPIDER FX EMBOLIC PROTECTION DEVICE DURING TREATMENT OF A 20MM CALCIFIED LESION IN THE PATIENT'S PROXIMAL RIGHT POPLITEAL ARTERY. SEVERE VESSEL CALCIFICATION IS REPORTED. ARTERY DIAMETER REPORTED AS 6MM. LESION EXHIBITED 80% STENOSIS. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 SALINE CONTRAST MIX FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITHOUT ISSUE. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT.  A BALLOON BURST IS REPORTED AT 8ATM ON FIRST INFLATION. NO FRAGMENTS WERE LEFT IN THE PATIENT. NO VESSEL DAMAGE. A SECOND PACIFIC XTREME PTA BALLOON WAS OPENED AND PREPPED WITHOUT ISSUE. THE SECOND PACIFIC XTREME BALLOON BURST AT 8ATM ON FIRST INFLATION. NO BALLOON FRAGMENTATION. NO FRAGMENTS WERE LEFT IN THE PATIENT. NO VESSEL DAMAGE.AN ADDITIONAL BALLOON OF THE IDENTICAL SIZE WAS TAKEN FROM THE CUSTOMERS CONSIGNMENT TO COMPLETE THE ANGIOPLASTY. NO PATIENT INJURY REP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12786739 ↗
• MalfunctionNov 7, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE A PACIFIC XTREME PTA BALLOON WITH A 6FRENCH 45CM NON-MEDTRONIC SHEATH AND 6MM SPIDER FX EMBOLIC PROTECTION DEVICE DURING TREATMENT OF A 20MM CALCIFIED LESION IN THE PATIENT'S PROXIMAL RIGHT POPLITEAL ARTERY. SEVERE VESSEL CALCIFICATION IS REPORTED. ARTERY DIAMETER REPORTED AS 6MM. LESION EXHIBITED 80% STENOSIS. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 SALINE CONTRAST MIX FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITHOUT ISSUE. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT.  A BALLOON BURST IS REPORTED AY 8ATM ON FIRST INFLATION. NO FRAGMENTS WERE LEFT IN THE PATIENT. NO VESSEL DAMAGE. A SECOND PACIFIC XTREME PTA BALLOON WAS OPENED AND PREPPED WITHOUT ISSUE. THE SECOND PACIFIC XTREME BALLOON BURST AT 8ATM ON FIRST INFLATION. NO BALLOON FRAGMENTATION. NO FRAGMENTS WERE LEFT IN THE PATIENT. NO VESSEL DAMAGE. AN ADDITIONAL BALLOON OF THE IDENTICAL SIZE WAS TAKEN FROM THE CUSTOMERS CONSIGNMENT TO COMPLETE THE ANGIOPLASTY. NO PATIENT INJURY RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12758111 ↗
• MalfunctionMar 27, 2021Burst Container or Vessel; Leak/Splash; Material Twisted/Bent; Burst Container or Vessel; Leak/Splash; Material Twisted/Bent

  PHYSICIAN WAS ATTEMPTING TO USE PACIFIC XTREME PTA BALLOON DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT MID TO DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 50% STENOSIS. THE VESSEL WAS NONE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 5MM AND 170MM RESPECTIVELY. A MEDTRONIC INFLATION DEVICE WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS NOT PREPPED PER IFU WITH NO ISSUES IDENTIFIED. DURING BALLOON INFLATION A PINHOLE LEAK WAS NOTED AT 8ATM. ALL BALLOON FRAGMENTS WERE RETRIEVED. BALLOON TWIST WAS ALSO NOTED. THE DEVICE DID NOT PASS THROUGHA PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE BALLOON WAS ADVANCED AND UPON INFLATION, UNDEPLOYED SEGMENT WAS NOTED UNDER FLUOROSCOPY. BALLOON WAS DEFLATED AND REINFLATED BUT UNDEPLOYED SEGMENT STILL VISIBLE. DURING SECOND INFLATION BALLOON BURST AT NOMINAL PRESSURE. BALLOON WAS REMOVED AND ANOTHER BALLOON WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11579997 ↗
• MalfunctionMar 19, 2021Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  PHYSICIAN WAS ATTEMPTING TO USE A PACIFIC XTREME PTA DURING PROCEDURE TO TREAT A LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 150MM RESPECTIVELY. 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. IT WAS REPORTED THAT BALLOON INFLATION DIFFICULTIES OCCURRED WITH BALLOON TWIST NOTED AT 6ATM. A REWRAP ISSUE WAS NOTED. A SECOND PACIFIC XTREME WAS ATTEMPTING AND SAME ISSUE OCCURRED. A TWIST WAS NOTED DURING BALLOON INFLATION AT 6ATM. A NON-MEDTRONIC BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11527780 ↗
• MalfunctionMar 19, 2021Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  PHYSICIAN WAS ATTEMPTING TO USE A PACIFIC XTREME PTA DURING PROCEDURE TO TREAT A LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 150MM RESPECTIVELY. 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. IT WAS REPORTED THAT BALLOON INFLATION DIFFICULTIES OCCURRED WITH BALLOON TWIST NOTED AT 6ATM. A REWRAP ISSUE WAS NOTED. A SECOND PACIFIC XTREME WAS ATTEMPTING AND SAME ISSUE OCCURRED. A TWIST WAS NOTED DURING BALLOON INFLATION AT 6ATM. A NON-MEDTRONIC BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11527724 ↗
• MalfunctionFeb 17, 2021Material Twisted/Bent

  PHYSICIAN INTENDED TO USE A PACIFIC XTREME PTA BALLOON DURING TREATMENT OF THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA). 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. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. A BALLOON TWIST IS REPORTED. A REWRAP ISSUE WAS NOT NOTED. IT IS REPORTED THE SAME BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11337551 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionOct 20, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN INTENDED TO USE A PACIFIC XTREME PTA BALLOON WITH A 6FR NON-MEDTRONIC SHEATH AND 0.014 SPIDER FX EMBOLIC PROTECTION DEVICE DURING TREATMENT OF A SOFT TISSUE LESION IN THE PATIENT¿S MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. 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. A PIN HOLE BURST ON THE BALLOON IS REPORTED AT INFLATION PRESSURE OF 12ATM. THE BALLOON WAS REMOVED, AND NO OTHER TREATMENT WAS PERFORMED AS IT WAS THE END OF THE PROCEDURE. NO PATIENT INJURY REPORTED.

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

  MAUDE report 10703741 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls