LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX35751060VRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00801741135521), received between Oct 19, 2018 and Apr 21, 2026 — classified as 19 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (2 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL ((B)(6)) THAT APPROXIMATELY ELEVEN MONTHS AND TWENTY ONE DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG COATED BALLOON CATHETER, THERE WAS DIFFICULTY IN CANNULATION DUE TO ACCESS SITE SCARRING AND CLOTS. REPORTEDLY, THE ADVERSE EVENT WAS NOT RELATED TO THE DEVICE AND PROCEDURE BUT POSSIBLY RELATED TO THE AV ACCESS CIRCUIT. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 24934594 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL STUDY THAT APPROXIMATELY ONE YEAR AND TWENTY-THREE DAYS POST INDEX PROCEDURE USING A LUTONIX 035 DRUG COATED BALLOON PTA CATHETER, IN THE LEFT FOREARM ON THE AXILLARY VEIN TARGET LESION, THE PATIENT HAD AN ADVERSE EVENT OF AVF CLOT. THE RELATIVITY OF THE EVENT WITH THE DEVICE, PROCEDURE OR CIRCUIT WAS NOT REPORTED. AV ACCESS CIRCUIT RE-INTERVENTION WAS NOT REQUIRED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24017768 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF THE STUDY (AV PAS) THAT SOMETIME LATER POST PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE BY USING LUTONIX DRUG COATED BALLOON PTA CATHETER ON THE BASILIC VEIN OF THE LEFT UPPER ARM FOR DILATION OF STENOSIS, THE SUBJECT HAD STENOSIS ON THE TARGET VEIN. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 23061769 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL (AV PAS / CL003301) THAT APPROXIMATELY SIX MONTHS AND A WEEK. POST INDEX PROCEDURE USING A LX35751060V LUTONIX 035AV DRUG COATED PTA DILATION CATHETER, IN THE LEFT UPPER ARM ON THE CEPHALIC VEIN TARGET LESION, THE PATIENT HAD AN ADVERSE EVENT OF OCCASIONAL LEFT-HAND NUMBNESS, TINGLING. THE RELATIVITY OF THE EVENT WITH THE DEVICE, PROCEDURE OR CIRCUIT WAS NOT REPORTED. AV ACCESS CIRCUIT RE-INTERVENTION WAS NOT REQUIRED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Numbness; Paresthesia

  MAUDE report 22792113 ↗
• MalfunctionJul 15, 2025Packaging Problem; Packaging Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A PROCEDURE USING THE LUTONIX 035AV DRUG COATED BALLOON (DCB) PTA CATHETER. PRIOR TO THE PROCEDURE, THE PRODUCT HAD ARRIVED DAMAGED. IT WAS FURTHER REPORTED THAT THE ENTIRE OUTER AND INNER PACKAGING WAS SMASHED, AND THE DEVICE WAS ALSO BENT OR SMASHED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22504819 ↗
• InjuryJul 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF THE CLINICAL TRIAL OF LUTONIX PRODUCT, THAT APPROXIMATELY ONE YEAR ONE MONTH AND FOUR DAYS POST ANGIOPLASTY PROCEDURE ON THE LEFT UPPER ARM BASILIC VEIN STENOSIS, THE SUBJECT DEVELOPED AN ADVERSE EVENT OF LEFT UPPER EXTREMITY OPEN AVF ANEURYSMORRHAPHY AND MID ARM SUPERFICIALIZATION. REPORTEDLY, THE ADVERSE EVENT RELATIONSHIP TO DEVICE AND PROCEDURE DETAILS WERE NOT PROVIDED. THE ADVERSE EVENT DID RESULT IN AV ACCESS CIRCUIT RE-INTERVENTION. HOWEVER, THE ADVERSE EVENT WAS RECOVERED.

  Patient problems: Aneurysm

  MAUDE report 22402307 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF THE STUDY (B)(6) THAT SOMETIME LATER POST PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE BY USING LUTONIX DILATION CATHETER ON THE CEPHALIC VEIN OF THE LEFT UPPER ARM FOR DILATION OF STENOSIS, THE SUBJECT HAD THROMBOSIS ON THE TARGET VEIN. HOWEVER, THE EVENT WAS POSSIBLY RELATED TO THE DEVICE.. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22392881 ↗
• InjuryApr 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY EIGHT MONTHS AND TWO DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN THE BASILIC VEIN, THE SUBJECT HAD AN ADVERSE EVENT OF BRACHIOBASILIC FISTULA STENOSIS/MALFUNCTION. REPORTEDLY, THE SUBJECT UNDERWENT AV ACCESS CIRCUIT RE-INTERVENTION IN THE TARGET LESION ON LEFT UPPER ARM FOR DECREASED ACCESS BLOOD FLOW. FURTHERMORE, A STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS USED DURING RE-INTERVENTION ON THE TARGET LESION UPPER ARM ON BASILIC VEIN. REPORTEDLY, THE RE-INTERVENTION WAS SUCCESSFUL AND THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 21838618 ↗
• InjuryApr 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY ONE YEAR AND EIGHTEEN DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN THE CEPHALIC VEIN STENOSIS, THE SUBJECT HAD AN ADVERSE EVENT OF CEPHALIC VEIN OUTFLOW STENOSIS. IT WAS FURTHER REPORTED THAT THE ADVERSE EVENT WAS POSSIBLY RELATED TO DEVICE AND NOT RELATED TO PROCEDURE BUT DEFINITELY RELATED TO AV ACCESS CIRCUIT. HOWEVER, RE-INTERVENTION WAS PERFORMED AND STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS USED IN RE-INTERVENTION ON THE TARGET LESION. FURTHERMORE, THE RE-INTERVENTION WAS SUCCESSFUL AND THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 21803313 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT ONE YEAR, FOUR MONTHS AND NINE DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER, IN THE CEPHALIC VEIN ARCH, THE SUBJECT HAD AN ADVERSE EVENT OF STOP PROLONGED BLEEDING DURING DIALYSIS AND STENOSIS REQUIRING RE-INTERVENTION. THE ADVERSE EVENT RESOLVED. IT WAS FURTHER REPORTED THAT RE-INTERVENTION WAS POSSIBLY RELATED TO THE DEVICE, PROCEDURE AND AV ACCESS CIRCUIT. THE CURRENT STATUS OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Restenosis; Stenosis

  MAUDE report 20731660 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT SIX MONTHS AND TWELVE DAYS POST AN INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN THE CEPHALIC VEIN, THE SUBJECT ALLEGEDLY UNDERWENT AV ACCESS RE-INTERVENTION IN THE TARGET LESION LEFT UPPER ARM FOR RECURRENT HVP. REPORTEDLY, LUTONIX AND OTHER DRUG COATED BALLOON WAS USED FOR RE-INTERVENTION AND IT WAS SUCCESSFUL. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: High Blood Pressure/ Hypertension; Restenosis; Stenosis

  MAUDE report 20513724 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT THREE MONTHS AND SIX DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER IN THE BASILIC VEIN AT OUTFLOW NEAR CANNULATION ZONE VIA THE LEFT UPPER ARM, THE SUBJECT HAD AN ADVERSE EVENT OF STENOSIS OF OUTFLOW NEAR CANNULATION ZONE IN BASILIC VEIN OF ARTERIOVENOUS FISTULA. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS IN THE UPPER ARM WITH FIFTY PERCENT INITIAL STENOSIS AND TWENTY PERCENT FINAL RESIDUAL STENOSIS. REPORTEDLY, STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE WAS PERFORMED TO TREAT BASILIC VEIN RESTENOSIS. TREATMENT RE-INTERVENTION WAS SUCCESSFUL, AND THE OUTCOME OF THE ADVERSE EVENT WAS RESOLVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 20227167 ↗
• InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF THE CLINICAL TRIAL THAT APPROXIMATELY ELEVEN MONTHS AND EIGHT DAYS POST ANGIOPLASTY PROCEDURE, THE SUBJECT DEVELOPED AN ADVERSE EVENT OF ANEURYSM FORMATION AND HYPERPULSATILE FISTULA. THE ADVERSE EVENT WAS TREATED WITH STENT PLACEMENT AND THE PATIENT RECOVERED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Aneurysm; Fistula

  MAUDE report 19192940 ↗
• InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF THE CLINICAL TRIAL THAT APPROXIMATELY THREE MONTHS AND NINETEEN DAYS POST ANGIOPLASTY PROCEDURE, THE SUBJECT DEVELOPED AN ADVERSE EVENT OF ANEURYSM FORMATION AND HIGH-FLOW ACCESS. THE ADVERSE EVENT WAS TREATED WITH NON-TARGET LESION CEPHALIC VEIN INFLOW WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND THE PATIENT RECOVERED. APPROXIMATELY NINE MONTHS AND THREE DAYS POST ANGIOPLASTY PROCEDURE, THE SUBJECT DEVELOPED AN ADVERSE EVENT OF HYPERPULSATILE FISTULA AND ANEURYSM FORMATION. THE ADVERSE EVENT WAS TREATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND THE PATIENT RECOVERED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Aneurysm; Fistula

  MAUDE report 19192891 ↗
• MalfunctionAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT AFTER INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN CEPHALIC VEIN, THE SUBJECT DEVELOPED AN ADVERSE EVENT OF EXTRAVASATION AT PUNCTURE SITE. IT WAS FURTHER REPORTED THAT THE ADVERSE EVENT DID NOT RESULT IN ADDITIONAL REINTERVENTION. REPORTEDLY, THE SEVERITY OF ADVERSE EVENT WAS MILD, AND THE OUTCOME WAS RECOVERED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17598233 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH RESULTS OF A CLINICAL TRIAL THAT TEN MONTHS AND FOUR DAYS POST INDEX PROCEDURE USING A DRUG COATED BALLOON CATHETER, THE SUBJECT HAD SERIOUS ADVERSE EVENT OF RECURRENT STENOSIS. THE ADVERSE EVENT RELATIONSHIP WAS POSSIBLY RELATED TO STUDY DEVICE, POSSIBLY RELATED TO PROCEDURE, AND DEFINITELY RELATED TO AV ACCESS CIRCUIT WHICH REQUIRED ADDITIONAL SURGICAL INTERVENTION. IT WAS FURTHER REPORTED THAT TEN MONTHS AND TWENTY-FOUR DAYS POST INDEX PROCEDURE, THE TARGET LESION HAD MAXIMUM INITIAL RECURRENT STENOSIS OF SIXTY-TWO PERCENT. OTHER DRUG COATED BALLOON CATHETER WAS USED FOR TREATMENT. THE RE-INTERVENTION WAS SUCCESSFUL, AND THE PATIENT RECOVERED WITH FINAL RESIDUAL STENOSIS OF FIFTY PERCENT. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 16362151 ↗
• MalfunctionSep 29, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG-COATED BALLOON ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS DEFLATED USING A NEEDLE. REPORTEDLY, THE CATHETER WAS CUT AND IT WAS PULLED BACK INTO THE SHEATH. THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15507683 ↗
• MalfunctionMay 27, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE ALLEGEDLY DID NOT REACH THE TARGETED LOCATION. THE LENGTH OF THE DEVICE WAS COMPARED WITH ANOTHER DEVICE LABELED TO BE OF THE SAME LENGTH AND WAS FOUND TO BE SHORTER. THE DEVICE WAS ALLEGEDLY REPORTED TO HAVE A LABELLING ISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11892191 ↗
• MalfunctionMay 27, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE ALLEGEDLY DID NOT REACH THE TARGETED LOCATION. THE LENGTH OF THE DEVICE WAS COMPARED WITH ANOTHER DEVICE LABELED TO BE OF THE SAME LENGTH AND WAS FOUND TO BE SHORTER. THE DEVICE WAS ALLEGEDLY REPORTED TO HAVE A LABELLING ISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11892164 ↗
• MalfunctionFeb 9, 2021Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT POST ANGIOPLASTY PROCEDURE IN THE CEPHALIC VEIN, THE PTA BALLOON ALLEGEDLY UNABLE TO REMOVE AND GOT STUCK IN THE SHEATH. IT WAS FURTHER REPORTED THAT THE SHEATH WAS REMOVED WITH THE BALLOON AND ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11300132 ↗
• InjuryAug 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A POST MARKET APPROVAL STUDY DURING THE INDEX PROCEDURE, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION IN THE LEFT UPPER ARM BRACHIAL CEPHALIC. APPROXIMATELY 133 DAYS POST INDEX PROCEDURE, THE TARGET LESION WAS REOCCLUDED. RE-INTERVENTION WAS PERFORMED WITH SUCCESSFUL RESULT. IT WAS FURTHER REPORTED THAT, APPROXIMATELY 11 MONTHS POST INDEX PROCEDURE, THE TARGET LESION WAS REOCCLUDED. RE-INTERVENTION WAS PERFORMED WITH SUCCESSFUL RESULT. THE INVESTIGATOR ASSESSED THE REOCCLUSION EVENTS WERE NOT RELATED TO THE STUDY DEVICE OR THE INDEX PROCEDURE.

  Patient problems: Reocclusion

  MAUDE report 8933079 ↗
• InjuryAug 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A POST MARKET APPROVAL STUDY DURING THE INDEX PROCEDURE, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION IN THE RIGHT UPPER ARM BASILIC VEIN SWING POINT. APPROXIMATELY 332 DAYS POST INDEX PROCEDURE, REPORTEDLY FISTULOGRAM INDICATED THE TARGET LESION WAS REOCCLUDED. ANGIOPLASTY WAS PERFORMED WITH SUCCESSFUL RESULT. THE INVESTIGATOR ASSESSED THE REOCCLUSION EVENT WAS NOT RELATED TO THE STUDY DEVICE OR TO THE INDEX PROCEDURE, BUT DEFINITELY RELATED TO THE AV ACCESS CIRCUIT .

  Patient problems: Reocclusion

  MAUDE report 8901924 ↗
• InjuryFeb 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A POST MARKET APPROVAL STUDY DURING THE INDEX PROCEDURE, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION IN THE CEPHALIC ARCH IN THE LEFT UPPER ARM AV FISTULA. APPROXIMATELY 3 MONTHS AFTER THE INDEX PROCEDURE, REPORTEDLY ANGIOGRAPHIC IMAGES INDICATED THE TARGET LESION WAS REOCCLUDED. A SURGICAL REVISION WAS PERFORMED BY THE HEALTH CARE PROFESSIONAL (HCP). ONE WEEK LATER, THE HCP PERFORMED A SWING DOWN PROCEDURE. THE INVESTIGATOR ASSESSED THE REOCCLUSION EVENT WAS NOT RELATED TO THE STUDY DEVICE OR TO THE INDEX 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 8335829 ↗
• InjuryJan 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A POST MARKET APPROVAL STUDY DURING THE INDEX PROCEDURE, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION IN THE CEPHALIC ARCH IN THE LEFT UPPER ARM AV FISTULA. APPROXIMATELY 3 MONTHS AFTER THE INDEX PROCEDURE, REPORTEDLY THE PATIENT HAD ELEVATED VENOUS PRESSURES DUE TO REOCCLUSION OF THE TARGET LESION. A CLINICALLY DRIVEN REVASCULARIZATION INVOLVING A FISTULOGRAM WITH ANGIOPLASTY WAS PERFORMED AND THE HEALTH CARE PROFESSIONAL (HCP) DEEMED IT WAS SUCCESSFUL. APPROXIMATELY TWO WEEKS AFTER THE REINTERVENTION, THE PROXIMAL SEGMENT OF THE CEPHALIC VEIN (NOT TARGET LESION) WAS OCCLUDED. THE HCP PERFORMED A SWING DOWN PROCEDURE AND IT WAS DEEMED SUCCESSFUL. THE INVESTIGATOR ASSESSED BOTH EVENTS WERE POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE AV ACCESS CIRCUIT, BUT NOT RELATED 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 8289546 ↗
• InjuryOct 19, 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 AXILLARY VEIN OF THE RIGHT UPPER ARM. APPROXIMATELY 7 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S TARGET LESION WAS REPORTEDLY REOCCLUDED, WHICH CAUSED DECREASED ACCESS BLOOD FLOW. A CLINICALLY DRIVEN REVASCULARIZATION WAS PERFORMED INVOLVING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND ADDITIONAL DCB TREATMENT. THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE, BUT DEFINITELY RELATED TO THE AV ACCESS CIRCUIT. 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 7984868 ↗