LUTONIX® Drug Coated Balloon LX3513061505FRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00801741123306), received between Nov 2, 2016 and Dec 30, 2024 — classified as 13 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2024Failure to Advance; Device-Device Incompatibility; Material Deformation; Failure to Advance; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG-COATED BALLOON ALLEGEDLY GOT STUCK ON THE DISTAL PART OF THE WIRE AND COULD NOT ADVANCE TO THE DESIGNATED VESSEL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21033749 ↗
• MalfunctionNov 29, 2022Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG-COATED BALLOON ALLEGEDLY RUPTURED AT 3 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15876026 ↗
• MalfunctionFeb 25, 2021Material Rupture; Material Rupture

  IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE, THE DRUG-COATED BALLOON WAS ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT, ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11377979 ↗
• InjuryJun 15, 2020Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN LEFT SUPERFICIAL FEMORAL ARTERY VIA IPSILATERAL APPROACH, THE DRUG-COATED BALLOON ALLEGEDLY BECAME STUCK IN THE SHEATH UPON REMOVAL. IT WAS FURTHER REPORTED THAT THE PHYSICIAN LOST ACCESS AFTER REMOVING THE DEVICE. THE PHYSICIAN USED ANOTHER PINNACLE SHEATH TO REGAIN ACCESS AND COMPLETE THE PROCEDURE. PATIENT STATUS IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 10153200 ↗
• MalfunctionNov 21, 2019Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY, THE DRUG COATED BALLOON RUPTURED AT 8 ATM, ON THE 3RD INFLATION ATTEMPT. AN ATHERECTOMY WAS REPORTEDLY PERFORMED PRIOR TO USE OF THE DRUG COATED BALLOON. THE HEALTH CARE PROVIDER IDENTIFIED A PINHOLE RUPTURE, AND ATTRIBUTED IT TO THE CALCIFICATION OF THE VESSEL. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ISSUE AND NO FURTHER TREATMENT WAS NEEDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9359190 ↗
• InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A (B)(6) CLINICAL STUDY THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WERE USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT FEMORAL ARTERY. APPROXIMATELY 10 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT FEMORAL ARTERY WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HEALTH CARE PROFESSIONAL (HCP) DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE, BUT NOT RELATED TO THE PROCEDURE.

  Patient problems: Reocclusion

  MAUDE report 9142523 ↗
• MalfunctionMay 9, 2019Material Rupture; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY FAILED TO INFLATE WHEN ATTEMPTING TO TREAT THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE HEALTH CARE PROFESSIONAL (HCP) USED A CONTRALATERAL APPROACH TO GAIN PATIENT ACCESS WITH A 6 FRENCH COOK INTRODUCER SHEATH OVER AN 018 TERUMO GUIDEWIRE. THE HCP PREDILATED THE HEAVILY CALCIFIED TARGET LESION. THE LUTONIX DCB WAS PREPARED BY ESTABLISHING NEGATIVE PRESSURE AND REMOVING THE BALLOON PROTECTOR WITHOUT ISSUES. THE HCP REPORTED NO NOTICEABLE DEFECTS OF THE LUTONIX DCB CATHETER. AFTER PREDILATION, THE HCP ADVANCED THE LUTONIX DCB TO THE TARGET LESION THROUGH A PREVIOUSLY PLACED STENT IN THE LEFT PROXIMAL SFA. THE HCP USED AN INFLATION DEVICE, BUT THE LUTONIX DCB BALLOON WOULD NOT INFLATE. THE HCP USED ANOTHER LUTONIX DCB TO COMPLETE THE PROCEDURE. THE LUTONIX DCB WAS RETURNED FOR EVALUATION AND A MATERIAL RUPTURE WAS DISCOVERED. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8597501 ↗
• MalfunctionApr 23, 2019Material Rupture; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURE AT 7 ATMOSPHERES (ATMS) WHILE TREATING A HEAVILY CALCIFIED TARGET LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE HEALTH CARE PROFESSIONAL (HCP) USED A CONTRALATERAL APPROACH TO GAIN PATIENT ACCESS WITH A 6 FRENCH COOK INTRODUCER SHEATH OVER AN 018 TERUMO GUIDEWIRE TO ACCESS THE TARGET LESION. THE HCP PREDILATED THE LESION SUCCESSFULLY. THE HCP PREPARED THE LUTONIX DCB BY REMOVING THE BALLOON PROTECTOR WITHOUT ISSUES. THE HCP ADVANCED THE LUTONIX DCB TO THE LEFT SFA, UNDER NEGATIVE PRESSURE, AND INFLATED THE BALLOON TO NOMINAL PRESSURE OF 7 ATMS. ONCE AT FULL INFLATION, THE BALLOON STARTED TO DEFLATE. IN THE OPINION OF THE HCP, THE HEAVILY CALCIFIED LESION MAY BE THE REASON FOR THE MATERIAL RUPTURE. THE HCP ALSO NOTED IT COULD BE A PINHOLE RUPTURE IN THE BALLOON. ANOTHER LUTONIX DCB WAS USED TO COMPLETE THE PROCEDURE. THE LUTONIX DCB WAS RETURNED FOR EVALUATION. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8542603 ↗
• InjuryJan 22, 2019Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT COMMON FEMORAL ARTERY (CFA) AND RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). TREATMENT IN THE RIGHT CFA IS NOT AN APPROVED INDICATION PER THE INSTRUCTIONS FOR USE (IFU), THUS THE PHYSICIAN USED THE LUTONIX DCB OFF-LABEL. APPROXIMATELY 6 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT'S TARGET LESION WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED ON THE TARGET LESION, RIGHT COMMON FEMORAL ARTERY (CFA), AND RIGHT MID SFA. THE REVASCULARIZATION ON THE TARGET LESION AND RIGHT CFA (NOT TARGET LESION) INVOLVED A SCORING BALLOON AND A NON-LUTONIX DCB. THE RIGHT MID SFA WAS TREATED WITH A DRUG ELUTING STENT (DES). THE HEATH CARE PROFESSIONAL (HCP) DEEMED THE REVASCULARIZATION SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE AND PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Reocclusion

  MAUDE report 8269088 ↗
• InjuryNov 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 18 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S TARGET LESION WAS REPORTEDLY REOCCLUDED VIA DUPLEX ULTRASOUND (DUS) IMAGING. A CLINICALLY DRIVEN REVASCULARIZATION WAS PERFORMED AND THE HEALTH CARE PROFESSIONAL (HCP) DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NEW INFORMATION: IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT APPROXIMATELY 33 MONTHS POST INDEX PROCEDURE, REOCCLUSION WAS IDENTIFIED VIA IMAGING.

  Patient problems: Reocclusion

  MAUDE report 8081966 ↗
• MalfunctionNov 8, 2018Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT ONE OF THREE LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS ALLEGEDLY WAS UNABLE TO BE INFLATED AFTER BEING ADVANCED TO THE TARGET LESION IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE HEALTH CARE PROFESSIONAL (HCP) USED A CONTRALATERAL APPROACH TO GAIN PATIENT ACCESS. THE HCP NOTED SOME VESSEL CALCIFICATION. REPORTEDLY, NO STENTS WERE PRESENT IN THE VESSEL PATHWAY OR IN THE TARGET LESION. THE HCP PREPARED THE FIRST LUTONIX DCB AND TREATED THE TARGET LOCATION WITHOUT ISSUES AND DEEMED THE FIRST TREATMENT SUCCESSFUL. THE HCP USED A SECOND LUTONIX DCB TO TREAT THE TARGET LESION, FURTHER. REPORTEDLY, THE HCP PREPARED THE SECOND LUTONIX DCB AND ADVANCED THE BALLOON UNDER NEGATIVE PRESSURE TO THE TARGET LESION. ALLEGEDLY, WHILE THE HCP WAS INFLATING THE BALLOON, THE DESIRED PRESSURE WAS NEVER ACHIEVED. REPORTEDLY, THE SECOND LUTONIX DCB WOULD NOT INFLATE. THE HCP REMOVED THE SECOND LUTONIX DCB AND TREATED THE TARGET LESION WITH ONE ADDITIONAL LUTONIX DCB, WHICH WAS SUCCESSFUL WITHOUT ISSUES. THE SECOND LUTONIX DCB WAS RETURNED FOR EVALUATION. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8054070 ↗
• InjuryAug 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 21 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA VASCULATURE WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Reocclusion

  MAUDE report 7818415 ↗
• MalfunctionJul 11, 2018Difficult to Remove; Material Split, Cut or Torn; Difficult to Remove; Material Split, Cut or Torn

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY WAS DIFFICULT TO REMOVE FROM THE PATIENT AFTER TREATING THE TARGET LESION IN THE LEFT LOWER EXTREMITY. THE HEALTH CARE PROFESSIONAL (HCP) ENCOUNTERED DIFFICULTY REMOVING THE LUTONIX DCB AFTER TREATMENT. THE INTRODUCER SHEATH (BRAND UNKNOWN) AND THE GUIDEWIRE (BRAND UNKNOWN) ALONG WITH THE CATHETER WERE REMOVED AS A SINGLE UNIT. THE HCP PROVIDED MANUAL COMPRESSION TO THE PATIENT'S ACCESS SITE AFTER THE EQUIPMENT WAS REMOVED. THE PHYSICIAN NOTED THE BALLOON PORTION OF THE LUTONIX DCB WAS SHEARED OFF AND FULLY CONTAINED INSIDE THE INTRODUCER SHEATH. REPORTEDLY, THE HCP CONFIRMED NO FOREIGN BODIES WERE LEFT IN THE PATIENT. THE LUTONIX DCB, ALONG WITH THE INTRODUCER SHEATH, WERE REQUESTED TO BE RETURNED FOR EVALUATION, BUT THE SAMPLE DISPOSITION IS UNKNOWN AT TIS TIME. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7677134 ↗
• InjuryJun 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT MID AND DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 22 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Reocclusion

  MAUDE report 7588002 ↗
• InjuryApr 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING A REVASCULARIZATION PROCEDURE, THREE LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 19 MONTHS AFTER THE REVASCULARIZATION PROCEDURE, THE PATIENT¿S LEFT SFA VASCULATURE WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SAMPLES WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBERS ARE 3006513822-2018-00075 AND 3006513822-2018-00076.

  Patient problems: Reocclusion

  MAUDE report 7394229 ↗
• InjuryApr 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING A REVASCULARIZATION PROCEDURE, THREE LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 19 MONTHS AFTER THE REVASCULARIZATION PROCEDURE, THE PATIENT¿S LEFT SFA VASCULATURE WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SAMPLES WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBERS ARE 3006513822-2018-00075 AND 3006513822-2018-00077.

  Patient problems: Reocclusion

  MAUDE report 7394099 ↗
• MalfunctionMar 16, 2018Material Rupture; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED WHILE TREATING A NON CALCIFIED TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE HEALTH CARE PROFESSIONAL (HCP) RETRACTED THE LUTONIX DCB THROUGH THE INTRODUCER SHEATH WITHOUT ISSUES. THE HCP USED A NEW BALLOON, WHICH WAS PREPPED IN THE NORMAL FASHION, AND USED TO COMPLETE THE PATIENT'S PROCEDURE. ALTHOUGH REQUESTED, ADDITIONAL EVENT DETAILS WERE UNAVAILABLE. THE LUTONIX DCB WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7344746 ↗
• InjuryMar 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER TREATMENT WITH FOUR LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS REPORTEDLY THE PATIENT EXPERIENCED HYPERTENSION, AND AN ITCHY RED RASH. THE HEALTH CARE PROFESSIONAL (HCP) ADMINISTERED HYDROCHLORIDE AND EPINEPHRINE. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT WAS ASYMPTOMATIC. NO FURTHER ADVERSE PATIENT OUTCOMES WERE REPORTED. THE LUTONIX DCB'S WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR EVALUATION. THIS IS ONE OF FOUR PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBERS ARE 3006513822-2018-00034, 3006513822-2018-00035, AND 3006513822-2018-00036.

  Patient problems: High Blood Pressure/ Hypertension; Hypersensitivity/Allergic reaction; Rash

  MAUDE report 7309468 ↗
• MalfunctionJan 8, 2018Material Rupture; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED AT 9 ATMOSPHERES (ATMS) WHILE TREATING THE TARGET LESION. THE HEALTH CARE PROFESSIONAL (HCP) USED A CONTRALATERAL APPROACH THROUGH THE RIGHT COMMON FEMORAL ARTERY TO TREAT THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE HCP DID NOT PREDILATE THE TARGET LESION AND IT IS UNKNOWN IF THE VESSEL WAS CALCIFIED OR TORTUOUS. THE HCP USED A COOK FLEXOR 6 FRENCH INTRODUCER SHEATH OVER A TERUMO 035 GLIDEWIRE TO ADVANCE THE LUTONIX DCB TO THE TARGET LESION. REPORTEDLY, THE LUTONIX DCB WAS INFLATED ONCE AND THE BALLOON RUPTURED WHILE ATTEMPTING TO TREAT THE TARGET LESION. THE LUTONIX DCB WAS REMOVED AND A SECOND LUTONIX DCB WAS USED TO COMPLETE THE PROCEDURE. THE LUTONIX DCB WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7172344 ↗
• InjuryNov 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 6 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT SFA VASCULATURE WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SAMPLES WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBER IS 3006513822-2017-00270.

  Patient problems: Reocclusion

  MAUDE report 6995533 ↗
• MalfunctionOct 30, 2017Material Rupture; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED AT APPROXIMATELY 9-10 ATMOSPHERES (ATMS) WHILE TREATING THE TARGET LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY(SFA) AND POPLITEAL ARTERY. THE HCP REMOVED THE LUTONIX DCB WITHOUT ISSUES AND USED ANOTHER LUTONIX DCB TO SUCCESSFULLY COMPLETE THE PATIENT'S PROCEDURE. ALTHOUGH REQUESTED, ADDITIONAL EVENT DETAILS AND PATIENT DEMOGRAPHICS ARE UNAVAILABLE. THE LUTONIX DCB WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6987191 ↗
• InjuryOct 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 2 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT SFA VASCULATURE WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBER IS 3006513822-2017-00226.

  Patient problems: Reocclusion

  MAUDE report 6983606 ↗
• InjuryOct 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 1 MONTH AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA VASCULATURE WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Reocclusion

  MAUDE report 6980502 ↗
• InjuryNov 2, 2016Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED AFTER THE HEALTH CARE PROFESSIONAL (HCP) INFLATED THE BALLOON THREE TIMES. THE HCP USED A CONTRALATERAL APPROACH WITH A 6 FRENCH INTRODUCER SHEATH AND AN ADVANTAGE GLIDEWIRE. THE TARGET LESION MORPHOLOGY AND PATHWAY TO THE LESION WAS NOT CALCIFIED OR TORTUOUS. THE LUTONIX DCB WAS PREPARED IN THE NORMAL FASHION AND THE BALLOON PROTECTOR WAS REMOVED WITHOUT ISSUES. THE HCP ADVANCED THE LUTONIX DCB UNDER NEGATIVE PRESSURE TO THE TARGET LESION AND SUCCESSFULLY INFLATED THE BALLOON FOR LESION TREATMENT. THE HCP THEN USED THE LUTONIX DCB FOR PREDILATION AT A DIFFERENT LESION LOCATION AND INFLATED THE DCB TWICE, WITH THE LAST INFLATION PRESSURE AT 10 ATMOSPHERES. THE PREVIOUS TWO INFLATION PRESSURES ARE UNKNOWN. ON THE THIRD INFLATION, THE BALLOON RUPTURED. THE HCP BELIEVES THE BALLOON DID NOT DEFLATE COMPLETELY. DURING THE REMOVAL OF THE BALLOON OVER THE GUIDEWIRE, THE HCP BELIEVES THE BALLOON BECAME CAUGHT ON CALCIFICATION WHICH CAUSED THE BALLOON TO BREAK AWAY FROM THE CATHETER. THE CATHETER WAS REMOVED FROM THE PATIENT WITH A PORTION OF THE INNER SHAFT AND THE DISTAL HA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6073708 ↗