Lutonix® Drug Coated Balloon LX35130640Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741088568), received between Aug 25, 2015 and Jan 4, 2019 — classified as 16 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJan 4, 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 POPLITEAL ARTERY. APPROXIMATELY 24 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT POPLITEAL VASCULATURE 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 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 8219227 ↗
• InjuryDec 7, 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, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT MID-DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 12 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT SFA VASCULATURE WAS REPORTEDLY REOCCLUDED VIA DUPLEX ULTRASOUND (DUS) IMAGING. 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 DEVICES 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 3006513822-2018-00282.

  Patient problems: Reocclusion

  MAUDE report 8144100 ↗
• InjuryDec 21, 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 DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 10 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT DISTAL SFA VASCULATURE WAS REPORTEDLY REOCCLUDED. APPROXIMATELY 22 MONTHS AFTER THE INDEX PROCEDURE, 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 7138514 ↗
• 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 RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 5 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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBER IS 3006513822-2017-00230.

  Patient problems: Reocclusion

  MAUDE report 6984226 ↗
• 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 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.

  Patient problems: Reocclusion

  MAUDE report 6980539 ↗
• 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 6 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 6980528 ↗
• InjurySep 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 PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 1 MONTH AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT PROXIMAL 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 6895229 ↗
• InjuryAug 18, 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 PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 6 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT PROXIMAL 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 6803383 ↗
• InjuryFeb 10, 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 8 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT 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 NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURERS REPORT NUMBER IS 3006513822-2017-00027.

  Patient problems: No Patient Involvement; Reocclusion

  MAUDE report 6321865 ↗
• InjuryFeb 10, 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 8 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT 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 NOT AVAILABLE FOR FURTHER 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 3006513822-2017-00028.

  Patient problems: Reocclusion

  MAUDE report 6321824 ↗
• InjuryJan 18, 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 16 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT SFA STENTED AREA 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 SAMPLES WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURERS REPORT NUMBER IS 3006513822-2017-00004.

  Patient problems: Reocclusion

  MAUDE report 6261529 ↗
• InjurySep 21, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN A CLINICAL REGISTRY IT WAS REPORTED 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 POPLITEAL ARTERY. APPROXIMATELY 2 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED CLAUDICATION AND IT WAS DETERMINED THE RIGHT PROXIMAL POPLITEAL VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED INVOLVING AN ATHERECTOMY. 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: Claudication; Reocclusion

  MAUDE report 5965619 ↗
• InjuryMay 24, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) DURING A (B)(6) STUDY PROCEDURE. APPROXIMATELY 7 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH COMPLAINTS OF CLAUDICATION. DIAGNOSTIC TESTING REVEALED THE RIGHT SFA STENTED AREA WAS REPORTEDLY REOCCLUDED. A FEMORAL BYPASS PROCEDURE WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE BUT WAS DEFINITELY RELATED TO THE INDEX PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND NOT AVAILABLE FOR FURTHER EVALUATION. NOTE, THE LUTONIX 035 DRUG COATED BALLOON PTA CATHETER IS INDICATED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), AFTER PRE-DILATATION OF DE NOVO OR RESTENOTIC LESIONS UP TO 150 MM IN LENGTH IN THE NATIVE SUPERFICIAL FEMORAL OR POPLITEAL ARTERIES WITH REFERENCE VESSEL DIAMETERS OF 4-7 MM. THESE LUTONIX DCB'S WERE USED TO TREAT THE STENTED LESION PER THE STUDY REQUIREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED EVEN

  Patient problems: Reocclusion

  MAUDE report 5675794 ↗
• InjuryApr 22, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED 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 MID TO DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 10 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT'S RIGHT SFA VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED USING ANGIOJET THROMBECTOMY, NORMAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), AND STENT PLACEMENT WHICH THE HCP DEEMED IT WAS SUCCESSFUL. AN ADDITIONAL REVASCULARIZATION ON (B)(6) 2016 WAS PERFORMED WITH AN ADDITIONAL ROTAREX AND NORMAL PTA. THE INVESTIGATOR ASSESSED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE, DRUG OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND ARE ASSOCIATED MANUFACTURERS REPORT NUMBERS 3006513822-2016-00096.

  Patient problems: Reocclusion

  MAUDE report 5599726 ↗
• MalfunctionApr 6, 2016Material Rupture; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED AT 4 ATMOSPHERES DURING THE FIRST INFLATION WHILE TREATING THE TARGET LESION IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY(SFA). A CONTRALATERAL APPROACHED WAS USED BY THE HEALTH CARE PROFESSIONAL (HCP) TO GAIN ACCESS WITH A 6 FRENCH TERUMO INTRODUCER SHEATH OVER AN 035 TERUMO GLIDEWIRE IN THE RIGHT COMMON FEMORAL ARTERY. THE HCP PREPARED THE LUTONIX DCB NORMALLY AND REMOVED THE BALLOON PROTECTOR WITHOUT ISSUES. THE HCP DID NOT APPLY NEGATIVE PRESSURE TO THE BALLOON DURING A SHORT ADVANCEMENT TO THE CALCIFIED TARGET LESION. AFTER THE LUTONIX DCB ALLEGEDLY RUPTURED, THE HCP REPORTEDLY REMOVED THE LUTONIX DCB WITHOUT DIFFICULTY THROUGH THE INTRODUCER SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A 5X40 ANGIOSCULPT FOLLOWED BY ANOTHER LUTONIX DCB. THE LUTONIX DCB WAS REQUESTED TO BE RETURNED FOR FURTHER EVALUATION. THERE WAS NO REPORTED CONSEQUENCE OR IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5550841 ↗
• MalfunctionFeb 2, 2016Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING OFF LABEL TREATMENT OF IN-STENT RESTENOSIS ON THE BRACHIOCEPHALIC VEIN A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED AT 10 ATMOSPHERES WITH THE FIRST INFLATION. THE HEALTH CARE PROFESSIONAL (HCP) GAINED PATIENT ACCESS WITH A 7 FRENCH INTRODUCER SHEATH AND TERUMO GLIDEWIRE. THE HCP PREPARED AND FLUSHED THE LUTONIX DCB IN THE NORMAL FASHION AND USED A BARD PRESTO INDEFLATOR TO INFLATE THE LUTONIX DCB. AFTER THE LUTONIX DCB RUPTURED, IT WAS REMOVED WITHOUT DIFFICULTY, AND ANOTHER LUTONIX DCB WAS USED TO SUCCESSFULLY TREAT THE TARGET VESSEL. THE PHYSICIAN WAS IN-SERVICED BY BARD PRE PROCEDURE REGARDING THE OFF LABEL USE OF LUTONIX DCB CATHETERS, BUT STILL ELECTED TO USE THE CATHETER FOR THE PATIENT PROCEDURE. BARD PERFORMED AN ADDITIONAL IN-SERVICE POST PROCEDURE REGARDING THE OFF LABEL USE AND PROPER USE OF LUTONIX DCB'S. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5404735 ↗
• InjuryDec 21, 2015Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INDEX PROCEDURE, THE PHYSICIAN USED TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS TO TREAT THE TARGET LESION LOCATED FROM THE SUPERFICIAL FEMORAL ARTERY (SFA) TO THE PROXIMAL POPLITEAL ARTERY OF THE RIGHT LEG. APPROXIMATELY 13 MONTHS LATER, THE HCP PERFORMED AN ATHERECTOMY TO SUCCESSFULLY RESOLVE THE REOCCLUSION OF THE PATIENT'S TARGET LIMB. THE SAMPLE WAS DISCARDED BY THE USER FACILITY, AND DIAGNOSTIC IMAGES HAVE BEEN REQUESTED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Reocclusion

  MAUDE report 5313374 ↗
• InjuryDec 16, 2015Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, AFTER TREATMENT WITH A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER, ALLEGEDLY A GRADE D DISSECTION OCCURRED. THE HEALTH CARE PROFESSIONAL (HCP) TREATED THE GRADE D DISSECTION WITH AN INTACT VASCULAR TACK ENDOVASCULAR SYSTEM. THE PATIENT WAS DISCHARGED THE SAME DAY, WITH NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND ARE ASSOCIATED MANUFACTURERS REPORT NUMBERS 3006513822-2015-00066.

  Patient problems: Intimal Dissection

  MAUDE report 5302042 ↗
• MalfunctionAug 25, 2015Material Rupture

  THE DESCRIPTION OF THE TRACKING PATHWAY AND LESION WITH REGARDS TO CALCIFICATION AND TORTUOSITY ARE UNKNOWN AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5030070 ↗