LUTONIX® Drug Coated Balloon LX3513051505FRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741123245), received between Jun 1, 2017 and Nov 14, 2025 — classified as 14 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE LUTONIX 035 DRUG COATED BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY LEAKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23552668 ↗
• MalfunctionSep 24, 2021Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY HAD A HOLE UPON INFLATION. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12524733 ↗
• InjuryDec 2, 2019Adverse 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 MID SUPERFICIAL FEMORAL ARTERY (SFA) . APPROXIMATELY 11 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT MID SFA VESSEL WAS REPORTEDLY REOCCLUDED. NO ADDITIONAL INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NEW INFORMATION: IT WAS REPORTED THAT APPROXIMATELY 30 MONTHS POST INDEX PROCEDURE, TARGET LESION STENOSIS WAS IDENTIFIED. IT WAS FURTHER REPORTED THAT REVASCULARIZATION WAS PERFORMED WITH SUCCESSFUL RESULT.

  Patient problems: Reocclusion

  MAUDE report 9397217 ↗
• InjuryJun 6, 2019Adverse 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 SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 9 MONTHS AFTER THE INDEX PROCEDURE, REPORTEDLY THE PATIENT¿S TARGET LESION WAS 70% REOCCLUDED DUE TO DUPLEX ULTRASOUND (DUS) IMAGING. ON THE SAME DAY, THE HEALTH CARE PROFESSIONAL (HCP) ELECTED TO PERFORM A REVASCULARIZATION ON THE TARGET LESION INVOLVING ATHERECTOMY, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), AND FURTHER DCB TREATMENT (BRAND UNKNOWN). THE HCP DEEMED THE REVASCULARIZATION SUCCESSFUL. THE SAMPLES WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT OUTCOMES WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBER IS 3006513822-2019-00090.

  Patient problems: Reocclusion

  MAUDE report 8676088 ↗
• InjuryJun 6, 2019Adverse 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 SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 9 MONTHS AFTER THE INDEX PROCEDURE, REPORTEDLY THE PATIENT¿S TARGET LESION WAS 70% REOCCLUDED DUE TO DUPLEX ULTRASOUND (DUS) IMAGING. ON THE SAME DAY, THE HEALTH CARE PROFESSIONAL (HCP) ELECTED TO PERFORM A REVASCULARIZATION ON THE TARGET LESION INVOLVING ATHERECTOMY, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), AND FURTHER DCB TREATMENT (BRAND UNKNOWN). THE HCP DEEMED THE REVASCULARIZATION SUCCESSFUL. THE SAMPLES WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT OUTCOMES WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBER IS 3006513822-2019-00091.

  Patient problems: Reocclusion

  MAUDE report 8675751 ↗
• InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A POST MARKET CLINICAL STUDY 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 RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 11 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA WAS REPORTEDLY REOCCLUDED VIA DUPLEX ULTRASOUND (DUS) IMAGING. NO REVASCULARIZATION WAS PERFORMED AT THIS TIME. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICES, BUT NOT RELATED TO THE INDEX 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 3006513822-2019-00076.

  Patient problems: Reocclusion

  MAUDE report 8601466 ↗
• InjuryApr 19, 2019Retraction Problem; Material Rupture; Material Split, Cut or Torn; Retraction Problem; Material Rupture; Material Split, Cut or Torn

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED ON ITS SECOND INFLATION AT 14 ATMOSPHERES (ATMS) WHILE TREATING A NON-TARGET LESION IN THE COMMON ILIAC. THE HEALTH CARE PROFESSIONAL (HCP) USED A CONTRALATERAL APPROACH WITH A 7 FRENCH ANSEL INTRODUCER SHEATH OVER AN UNKNOWN 035 GUIDEWIRE TO TREAT THE TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE HCP REPORTEDLY USED A HAWK ONE ATHERECTOMY OVER AN 014 GUIDEWIRE TO PREPARE THE TARGET LESION IN THE SFA. REPORTEDLY, THE 014 GUIDEWIRE WAS EXCHANGED FOR AN 035 GUIDEWIRE IN PREPARATION TO ADVANCE THE LUTONIX 035 CATHETER. THE HCP THEN REACHED THE TARGET LESION WITH THE LUTONIX DCB AND ALLEGEDLY INFLATED THE DEVICE TO 8 ATMS. AFTER SUCCESSFUL TREATMENT OF THE SFA, THE HCP PULLED THE LUTONIX DCB TO A STENOSED REGION OF THE COMMON ILIAC ARTERY AND INFLATED THE LUTONIX DCB TO 14 ATMS. REPORTEDLY, THE LUTONIX DCB RUPTURED DURING THIS INFLATION ATTEMPT. UPON ATTEMPTS TO REMOVE THE DEVICE, REPORTEDLY THE BALLOON WOULD NOT RE-SHEATH, RESULTING IN THE BALLOON PORTION BECOMING STUCK IN THE INTRODUCER SHEATH. EVENTUALLY, THE HCP TORE THE BALLOON AND THE BALLOON PORTION B

  Patient problems: Foreign Body In Patient

  MAUDE report 8531615 ↗
• InjuryNov 20, 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 THIRD REVASCULARIZATION PROCEDURE, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 7 MONTHS AFTER THIS THIRD REVASCULARIZATION PROCEDURE, THE PATIENT¿S LEFT MID SFA VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED INVOLVING ADDITIONAL DEVICES 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.

  Patient problems: Reocclusion

  MAUDE report 8093087 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE ULTRASCORE CLINICAL REGISTRY, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED AS THE PRIMARY TREATMENT FOR AN OCCLUDED TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE HEALTH CARE PROFESSIONAL (HCP) PREDILATED THE TARGET LESION WITH AN ULTRASCORE BALLOON SUCCESSFULLY. THE HCP PERFORMED IMAGING AND THE VESSEL WAS CLEAR OF ALL OBSTRUCTIONS. THE HCP USED TWO LUTONIX DCB'S TO TREAT THE TARGET LESION LOCATION SUCCESSFULLY. REPORTEDLY, THE HCP PERFORMED IMAGING AFTER DCB TREATMENT AND THE VESSEL WAS OBSTRUCTED DUE TO A GRADE C DISSECTION. THE HCP USED A STENT TO CORRECT THE OBSTRUCTED FLOW IN THE TREATED VESSEL. THE LUTONIX DCBS WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR EVALUATION. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS UNABLE TO BE OBTAINED. NO ADVERSE PATIENT OUTCOMES WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBER IS 3006513822-2018-00265.

  Patient problems: Intimal Dissection

  MAUDE report 8069810 ↗
• MalfunctionNov 8, 2018Material Rupture; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY WOULD NOT INFLATE. IT WAS OBSERVED A SMALL AMOUNT OF CONTRAST WAS COMING FROM THE BALLOON WHILE TREATING THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE HEALTH CARE PROFESSIONAL (HCP) USED A CONTRALATERAL APPROACH THROUGH THE RIGHT COMMON FEMORAL ARTERY WITH A 6 FRENCH COOK FLEXOR FLO INTRODUCER SHEATH OVER A BOSTON SCIENTIFIC V-14 CONTROL 014 GUIDEWIRE. THE HCP PREDILATED THE NON CALCIFIED TARGET LESION WITH A MULTIPLE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOONS PRIOR TO TREATING THE TARGET LESION WITH A LUTONIX DCB. THE HCP REMOVED THE LUTONIX DCB AND COMPLETED THE PROCEDURE WITH A STENT (BRAND UNKNOWN). THE LUTONIX DCB WAS RETURNED FOR EVALUATION. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8054082 ↗
• InjuryOct 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A POST MARKET CLINICAL STUDY 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 POPLITEAL ARTERY. APPROXIMATELY 4 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT POPLITEAL 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 NOT RELATED TO THE STUDY DEVICE OR TO THE 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 8012027 ↗
• MalfunctionAug 31, 2018Difficult to Remove; Material Split, Cut or Torn; Difficult to Remove; Material Split, Cut or Torn

  IT WAS REPORTED, AFTER OFF-LABEL TREATMENT OF THE TARGET LESION DURING RETRACTION, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY BROKE OFF AT THE DISTAL TIP OF THE INTRODUCER SHEATH IN THE RIGHT EXTERNAL ILIAC ARTERY. THE HEALTH CARE PROFESSIONAL (HCP) WAS TREATING A TARGET LESION IN THE TORTUOUS LEFT COMMON FEMORAL ARTERY WITH A LUTONIX 5 MM X 150 MM DCB. THE HCP USED A COOK 5 FRENCH FLEXOR CHECK-FLO INTRODUCER SHEATH OVER A GUIDEWIRE (BRAND UNKNOWN) TO GAIN PATIENT ACCESS. AFTER A SUCCESSFUL INFLATION AND DEFLATION OF THE LUTONIX DCB, THE HCP STARTED TO RETRACT THE CATHETER. THE CATHETER BROKE OFF AT THE DISTAL END OF THE INTRODUCER SHEATH. IT IS UNKNOWN, IF THE LUTONIX DCB WAS CONFIRMED TO BE DEFLATED UNDER FLUOROSCOPY OR IF NEGATIVE PRESSURE WAS APPLIED PRIOR TO RETRACTION. THEN, THE HCP ATTEMPTED TO REINSERT THE GUIDEWIRE INTO THE INNER LUMEN OF THE BROKEN OFF PORTION OF THE BALLOON. THIS ATTEMPT WAS UNSUCCESSFUL. THE HCP REMOVED THE INTRODUCER SHEATH AND THE BROKEN OFF BALLOON PORTION WAS LODGED IN THE DISTAL TIP OF THE INTRODUCER SHEATH. ONCE THE INTRODUCER SHEATH WAS REMOVED, THE BALLOON PORTION WAS ALSO REMOVED FROM THE PATIENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7837522 ↗
• InjuryMay 21, 2018Deflation Problem; Difficult to Remove; Device-Device Incompatibility; Deflation Problem; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED, THROUGH A MEDWATCH REPORT FROM THE USER FACILITY, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY WAS UNABLE TO BE COMPLETELY DEFLATED DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. THE PARTIALLY DEFLATED BALLOON WAS UNABLE TO BE RETRACTED THROUGH A 7 FRENCH 45 CM INTRODUCER SHEATH. THE HEALTH CARE PROFESSIONAL (HCP) PREPARED THE TARGET LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) VIA ATHERECTOMY. THE HCP PRE-DILATED THE DISTAL AND PROXIMAL SEGMENTS OF THE TARGET LESION. THE HCP USED A 035 J-SHAPED GUIDEWIRE TO DELIVER THE LUTONIX 035 DCB. DURING PREPARATION, THE HCP NOTED THE 035 GUIDEWIRE DID NOT EASILY PASS THROUGH THE INNER LUMEN OF THE LUTONIX DCB. THE HCP EXCHANGED THE 035 J-SHAPED GUIDEWIRE FOR A TERUMO GLIDEWIRE, BUT ENCOUNTERED THE SAME ISSUE. FINALLY, THE HCP SUCCESSFULLY PASSED A 018 STIFF COMMAND GUIDEWIRE THROUGH THE INNER LUMEN AND THE LUTONIX DCB WAS ADVANCED TO THE TARGET LESION. THE HCP NOTED DIFFICULTY PASSING THE 018 GUIDEWIRE THROUGH THE HUB OF THE LUTONIX DCB, SPECIFICALLY WHERE THE INNER SHAFT INTERFACES WITH THE HUB. AFTER TREATING THE MOST DISTAL PORTION OF THE TARGET LESION

  Patient problems: Intimal Dissection

  MAUDE report 7531070 ↗
• MalfunctionMar 16, 2018Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED UPON INFLATING TO NOMINAL PRESSURE IN A HARD CALCIFIED TARGET LESION LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. THE HEALTH CARE PROFESSIONAL (HCP) USED A CONTRALATERAL APPROACH THROUGH THE RIGHT COMMON FEMORAL ARTERY TO GAIN PATIENT ACCESS WITH A 6 FRENCH TERUMO DESTINATION INTRODUCER SHEATH OVER A SUPRACORE GUIDEWIRE. THE HCP USED A CSI ORBITAL ATHERECTOMY TO DEBULK THE ARTERY, ALONG WITH A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON TO PREDILATE THE TARGET LESION. AFTER PREPARING THE TARGET LESION, THE HCP ADVANCED THE LUTONIX DCB AND INFLATED THE BALLOON IN THE TARGET LESION. UPON INFLATING THE LUTONIX DCB TO NOMINAL PRESSURE, ALLEGEDLY IT RUPTURED. THE HCP REMOVED THE RUPTURED DCB AND USED ANOTHER DEVICE TO COMPLETE THE PATIENT'S PROCEDURE. THE LUTONIX DCB WAS REQUESTED TO BE RETURNED FOR EVALUATION. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7344789 ↗
• InjuryMar 12, 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, 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 13 MONTHS AFTER THE REVASCULARIZATION PROCEDURE, THE PATIENT¿S LEFT DISTAL SFA WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR'S ASSESSMENT OF WHETHER THE EVENT WAS RELATED TO THE STUDY DEVICE OR PROCEDURE IS UNKNOWN. 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 7330236 ↗
• 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 3006513822-2018-00037.

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

  MAUDE report 7309323 ↗
• 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 3006513822-2018-00035, 3006513822-2018-00036, AND 3006513822-2018-00037.

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

  MAUDE report 7309263 ↗
• MalfunctionOct 24, 2017Material Rupture; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED AT 6 ATMOSPHERES (ATMS) WHILE TREATING THE TARGET LESION LOCATED IN THE LEFT POPLITEAL ARTERY. THE HEALTH CARE PROFESSIONAL (HCP) USED A CONTRALATERAL APPROACH TO TREAT THE POPLITEAL ARTERY. REPORTEDLY, THE ENTIRE SUPERFICIAL FEMORAL ARTERY (SFA) PATHWAY WAS HEAVILY CALCIFIED, AND THE HCP DID NOT PREDILATE THE TARGET LESION IN THE POPLITEAL ARTERY. THE HCP PREPARED THE LUTONIX DCB IN THE NORMAL FASHION AND SUCCESSFULLY APPLIED NEGATIVE PRESSURE TO THE BALLOON PRIOR TO INSERTING THE CATHETER INTO THE PATIENT. REPORTEDLY, THE HCP DID NOT APPLY NEGATIVE PRESSURE TO THE BALLOON WHILE ADVANCING THE CATHETER TO THE TARGET LESION. ON THE FIRST INFLATION, THE HCP ALLEGEDLY INFLATED THE LUTONIX DCB TO 6 ATMS. THE RUPTURED LUTONIX DCB WAS SUCCESSFULLY REMOVED IN IT'S ENTIRETY. REPORTEDLY, THE RUPTURE WAS A IDENTIFIED BY THE HCP TO BE A PINHOLE. IN THE HCP'S OPINION, THE CALCIFICATION IN THE SFA WAS THE REASON THE LUTONIX DCB RUPTURED. THE HCP REPORTEDLY USED AN ADDITIONAL TWO LUTONIX DCB'S TO SUCCESSFULLY COMPLETE THE PATIENT'S PROCEDURE. THE LUTONIX DCB WAS DISCARDED BY THE U

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6972736 ↗
• InjuryOct 11, 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 RIGHT MID AND DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE PATIENT PRESENTED TO THE HOSPITAL WITH A FOOT WOUND IN (B)(6) 2016. DURING THIS HOSPITALIZATION, THE PATIENT'S WOUND WAS DEBRIDED AND THE PATIENT'S INDEX PROCEDURE WAS COMPLETED. ONE MONTH LATER, ON (B)(6) 2016, THE PATIENT'S FIFTH METATARSAL WAS AMPUTATED. APPROXIMATELY 5 MONTHS AFTER THE INDEX PROCEDURE, A DUPLEX ULTRASOUND WAS COMPLETED, ON (B)(6) 2017, RESULTING IN 50-90% OCCLUSION OF THE TARGET LESION. THREE MONTHS LATER, ON (B)(6) 2017, THE PATIENT HAD SIGNS OF A WORSENING FOOT ULCER ON THE TARGET LIMB. THE PATIENT WENT TO THE HOSPITAL FOR TREATMENT AND THEIR FOOT ULCER WAS DEBRIDED. THE INVESTIGATOR ASSESSED THAT THE FOOT ULCER WAS POSSIBLY RELATED TO THE STUDY DEVICE AND THE PROCEDURE. THE HCP'S ASSESSMENT OF THE PATIENT'S FOOT WAS IDENTIFIED ON (B)(6) 2018 AND AN ULTRASOUND WAS PERFORMED, RESULTING IN 50-90% OCCLUSION OF THE TARGET LESION. THE PATIENT'S 3RD AND 4TH TOE'S ON THE TARGET LIMB WERE AMPUTATED

  Patient problems: Necrosis; Reocclusion; Ulcer

  MAUDE report 6940301 ↗
• MalfunctionAug 10, 2017Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS ALLEGEDLY UNABLE TO BE INFLATED DUE TO A CIRCUMFERENTIAL RUPTURE AT THE PROXIMAL END OF THE BALLOON. THE HEALTH CARE PROFESSIONAL (HCP) USED THE LEFT COMMON FEMORAL ARTERY AS A CONTRALATERAL APPROACH TO GAIN PATIENT ACCESS WITH 6 FRENCH COOK ANSEL INTRODUCER SHEATH OVER AN 035 ADVANTAGE GUIDEWIRE TO TREAT THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). REPORTEDLY, THE HCP DID NOT PREDILATE THE TARGET LESION. THE HCP PREPARED THE LUTONIX DCB IN THE NORMAL FASHION AND REMOVED THE BALLOON PROTECTOR WITHOUT ISSUES. ALLEGEDLY, THE HCP ADVANCED THE LUTONIX DCB TO THE CALCIFIED AORTIC BIFURCATION, BUT HAD DIFFICULTY TRAVERSING THE CALCIFIED REGION. REPORTEDLY, NEGATIVE PRESSURE WAS NOT ESTABLISHED PRIOR TO THE ADVANCEMENT OF THE LUTONIX DCB TO THE TARGET LESION. THE HCP WAS ABLE TO CROSS THE AORTIC BIFURCATION AND REACHED THE TARGET LESION, BUT ALLEGEDLY THE LUTONIX DCB BALLOON WOULD NOT INFLATE. THE HCP REMOVED THE LUTONIX DCB SUCCESSFULLY. REPORTEDLY, A LASER ATHERECTOMY WAS PERFORMED AFTER UPSIZING THE INTRODUCER SHEATH AND THE TARGET LESION WAS TREATED WITH A DIFFERENT MANUFACTURERS DEVIC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6786268 ↗
• MalfunctionJun 15, 2017Material Rupture; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED AT 4 ATMOSPHERES WHILE BEING INFLATED WITHIN A PREVIOUSLY PLACED STENT. THE HEALTH CARE PROFESSIONAL (HCP) USED A CONTRALATERAL APPROACH THROUGH THE COMMON FEMORAL ARTERY TO GAIN ACCESS TO THE PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA). THE HCP USED A 6 FRENCH TERUMO PINNACLE DESTINATION INTRODUCER SHEATH OVER A TERUMO GUIDEWIRE. THE TARGET LESION WAS REPORTED PREDILATED WITH A 5X150 CORDIS POWERFLEX. REPORTEDLY, THE TARGET LESION WAS NOT CALCIFIED OR TORTUOUS. THE LUTONIX DCB WAS REQUESTED TO BE RETURNED FOR EVALUATION. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6642615 ↗
• InjuryJun 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, 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 11 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 THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Reocclusion

  MAUDE report 6604323 ↗