LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575860VRecalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00801741135460), received between Feb 14, 2018 and Dec 15, 2025 — classified as 3 deaths, 44 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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 54 reports, in the reporter's own words as published by the FDA.

• InjuryDec 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 (CL003301) THAT APPROXIMATELY FIFTEEN DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER, THE SUBJECT HAD AN ADVERSE EVENT OF ¿LUE AVF INFECTION¿. REPORTEDLY, THE ADVERSE EVENT WAS NOT RELATED TO THE DEVICE AND PROCEDURE BUT DEFINITELY RELATED TO THE AV ACCESS CIRCUIT. IT WAS FURTHER REPORTED THAT, THE PATIENT ALSO HAD AN ADVERSE EVENT OF "LUE AVF CLOT". THE RELATIVITY OF THE EVENT WITH THE DEVICE, PROCEDURE AND THE AV ACCESS CIRCUIT WAS NOT REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Restenosis; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 23800554 ↗
• InjuryJul 10, 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 (B)(4), THAT SOMETIME POST AN INDEX PROCEDURE, THE SUBJECT HAD AN ADVERSE EVENT OF RIGHT UPPER EXTREMITY ARTERIOVENOUS FISTULA DISCOMFORT DURING DIALYSIS, ANEURYSM. THE ADVERSE EVENT RELATIONSHIP TO DEVICE, PROCEDURE AND AV ACCESS CIRCUIT DETAILS WERE NOT PROVIDED. THE SUBJECT REPORTED MILD DISCOMFORT DURING DIALYSIS AND NO INTERVENTION PERFORMED CURRENTLY. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Aneurysm; Discomfort; Obstruction/Occlusion; Pain; Thrombosis/Thrombus

  MAUDE report 22466730 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT THE LUTONIX DRUG COATED BALLOON PROCEDURE. IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY FIVE MONTHS AND THREE DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN THE RIGHT UPPER ARM ON THE CEPHALIC VEIN TARGET LESION, THE SUBJECT HAD AN ADVERSE EVENT OF ANGIOGRAM/FISTULOGRAM AND ANGIOPLASTY TO TREAT PERIANASTOMOTIC OUTFLOW. IT WAS FURTHER REPORTED THAT THE ADVERSE EVENT WAS NOT RELATED TO STUDY DEVICE AND STUDY PROCEDURE BUT DEFINITELY RELATED TO AV ACCESS CIRCUIT. HOWEVER, A RE-INTERVENTION WAS PERFORMED BY USING STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, CUTTING/SCORING BALLOON AND OTHER DRUG COATED BALLOON ON THE NEW LESION WITHIN THE ACCESS CIRCUIT WITH INITIAL STENOSIS OF 91% AND FINAL RESIDUAL STENOSIS OF 35%. HOWEVER, THE CORE LAB ANALYSIS SHOWED THAT THE RE-INTERVENTION INVOLVED ON THE TARGET LESION ON THE BRACHIAL VEIN WITH INITIAL STENOSIS OF 52.1% AND FINAL RESIDUAL STENOSIS OF 20%. FURTHERMORE, THE RE-INTERVENTION WAS SUCCESSFUL, AND THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 22159592 ↗
• InjuryMay 30, 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 TEN MONTHS AND FOUR DAYS POST AN INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN THE CEPHALIC VEIN, THE SUBJECT HAD AN ADVERSE EVENT OF EXCISION OF ANEURYSM RIGHT BRACHIOCEPHALIC AVF. IT WAS FURTHER REPORTED THAT THE ADVERSE EVENT WAS NOT RELATED TO STUDY DEVICE AND STUDY PROCEDURE BUT DEFINITELY RELATED TO AV ACCESS CIRCUIT. REPORTEDLY, THE SUBJECT UNDERWENT SURGICAL REVISION AND EXCISION OF AVF AND THE RE-INTERVENTION WAS SUCCESSFUL. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Aneurysm

  MAUDE report 22112829 ↗
• InjuryMay 12, 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 SEVEN MONTHS AND FOUR DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN THE CEPHALIC VEIN FOR TARGET LESION STENOSIS, THE SUBJECT HAD AN ADVERSE EVENT OF PROLONGED BLEEDING FOLLOWING CANNULATION. IT WAS FURTHER REPORTED THAT THE ADVERSE EVENT WAS RELATIONSHIP WAS NOT RELATED TO THE DEVICE AND PROCEDURE BUT DEFINITELY RELATED TO THE ARTERIOVENOUS ACCESS CIRCUIT. REPORTEDLY, SOMETIME LATER A TARGET LESION RE-INTERVENTION WAS PERFORMED FOR PROLONGED BLEEDING. A STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED ON THE TARGET LESION ON CEPHALIC VEIN WITH INITIAL STENOSIS OF 50% AND FINAL RESIDUAL STENOSIS OF 10%. REPORTEDLY, THE RE-INTERVENTION WAS SUCCESSFUL AND THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Restenosis

  MAUDE report 22000450 ↗
• InjuryApr 11, 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 NINE MONTHS AND TWENTY-FOUR DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN THE CEPHALIC VEIN, THE SUBJECT HAD AN ADVERSE EVENT OF DIFFICULT CANNULATING DUE TO STENOSIS. REPORTEDLY, THE ADVERSE EVENT WAS NOT RELATED TO STUDY DEVICE AND STUDY PROCEDURE BUT DEFINITELY RELATED TO AV ACCESS CIRCUIT. IT WAS FURTHER REPORTED THAT THE SUBJECT UNDERWENT AV ACCESS CIRCUIT RE-INTERVENTION IN THE TARGET LESION ON LEFT UPPER ARM FOR DIFFICULT PUNCTURE. FURTHERMORE, A STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS USED DURING RE-INTERVENTION ON THE TARGET LESION ON CEPHALIC VEIN WITH INITIAL STENOSIS OF 50% AND FINAL RESIDUAL STENOSIS OF 40%. REPORTEDLY, THE RE-INTERVENTION WAS SUCCESSFUL AND THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Restenosis; Stenosis

  MAUDE report 21823503 ↗
• InjuryMar 12, 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 ONE MONTH AND NINE DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN THE CEPHALIC VEIN, THE SUBJECT HAD AN ADVERSE EVENT OF CEPHALIC ARCH STENOSIS. IT WAS FURTHER REPORTED THAT THE ADVERSE EVENT WAS NOT RELATED TO DEVICE AND PROCEDURE BUT DEFINITELY RELATED TO AV ACCESS CIRCUIT. HOWEVER, RE-INTERVENTION WAS PERFORMED AND STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND OTHER DRUG COATED BALLOON WAS USED IN RE-INTERVENTION ON THE TARGET LESION WITH INITIAL STENOSIS OF 49% AND FINAL RESIDUAL STENOSIS OF 23%. FURTHERMORE, THE RE-INTERVENTION WAS SUCCESSFUL AND THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 21583141 ↗
• InjuryDec 10, 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 TWO MONTHS SIXTEEN DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER, IN THE UPPER LEFT ARM OF BRACHIAL VEIN, THE SUBJECT HAD AN ADVERSE EVENT OF AV ACCESS RE-INTERVENTION FOR ANEURYSMAL CHANGES. IT WAS FURTHER REPORTED THAT THE ADVERSE EVENT WAS DEFINITELY RELATED TO THE DEVICE, PROCEDURE AND AV ACCESS CIRCUIT. REPORTEDLY, THE SUBJECT UNDERWENT AV ACCESS CIRCUIT RE-INTERVENTION OF PATCH ANGIOPLASTY OF STENOSIS AND ANEURYSM REPAIR INVOLVED ON THE TARGET LEFT ARM ON THE TARGET LESION BASILIC VEIN WITH INITIAL STENOSIS OF 80% AND FINAL RESIDUAL STENOSIS OF 10%. FURTHERMORE, THE RE-INTERVENTION WAS SUCCESSFUL AND THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Aneurysm; Restenosis

  MAUDE report 20890157 ↗
• 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 SEVEN MONTHS AND TWENTY-FOUR DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER, IN THE BASILIC VEIN, 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; Obstruction/Occlusion; Restenosis; Stenosis

  MAUDE report 20731439 ↗
• InjuryOct 28, 2024Adverse 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 TWO MONTHS AND AND SEVENTEEN DAYS POST AN INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER ON THE LEFT UPPER ARM FOR STENOSIS, THE SUBJECT ALLEGEDLY HAD AN ADVERSE EVENT OF RECURRENCE OF STENOSIS ON THE BASILIC VEIN. IT WAS FURTHER REPORTED THAT THE ADVERSE EVENT RELATIONSHIP WAS NOT RELATED TO THE DEVICE AND PROCEDURE BUT DEFINITELY RELATED TO THE AV ACCESS CIRCUIT. REPORTEDLY, A STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS USED FOR RE-INTERVENTION ON THE TARGET LESION BASILIC VEIN WITH INITIAL STENOSIS 70% AND FINAL RESIDUAL STENOSIS 30%. FURTHERMORE, THE RE-INTERVENTION WAS SUCCESSFUL AND THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Restenosis; Thrombosis/Thrombus

  MAUDE report 20543261 ↗
• InjuryOct 28, 2024Adverse 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 SIX MONTHS AND TWENTY DAYS POST AN INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER, THE SUBJECT ALLEGEDLY DEVELOPED ADVERSE EVENT OF PERSISTENT BLEEDING IN ARTERIOVENOUS FISTULA WHICH REQUIRED ADDITIONAL INTERVENTION. REPORTEDLY, THE ADVERSE EVENT RELATEDNESS TO DEVICE, PROCEDURE, AND ARTERIOVENOUS ACCESS CIRCUIT WERE NOT PROVIDED. IT WAS FURTHER REPORTED THAT THE SUBJECT UNDERWENT RE-INTERVENTION FOR PROLONGED BLEEDING AND STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS USED IN RE-INTERVENTION THAT INVOLVED ON THE TARGET LESION WITH INITIAL STENOSIS OF SIXTY PERCENT AND FINAL RESIDUAL STENOSIS OF TEN PERCENT. APPROXIMATELY EIGHT MONTHS AND THIRTEEN DAYS POST INDEX PROCEDURE, THE SUBJECT WAS EXPIRED AND THE CAUSE OF DEATH INFORMATION WERE NOT PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Restenosis

  MAUDE report 20543258 ↗
• InjuryAug 21, 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 FOUR MONTHS TWENTY-SEVEN DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER, IN THE CEPHALIC VEIN ARCH, THE SUBJECT HAD AN ADVERSE EVENT OF DYSFUNCTIONAL LEFT AV FISTULA WITH ULCERATED ANEURYSM. IT WAS FURTHER REPORTED THAT THE ADVERSE EVENT WAS POSSIBLY RELATED TO THE DEVICE, DEFINITELY RELATED TO THE AV ACCESS CIRCUIT AND NOT RELATED TO THE PROCEDURE. REPORTEDLY, THE SUBJECT UNDERWENT AV ACCESS CIRCUIT REINTERVENTION INVOLVED ON THE TARGET LEFT ARM FOR PROLONGED BLEEDING AND PSEUDOANEURYSM. FURTHERMORE, SURGICAL REVISION WAS PERFORMED FOR ANEURYSM IN LEFT MID FISTULA AND THE RE-INTERVENTION WAS NOT SUCCESSFUL AND FISTULA WAS LIGATED. IT WAS FURTHER REPORTED THAT THE APPROXIMATELY ONE YEAR THREE MONTHS AND ELEVEN DAYS POST INDEX PROCEDURE, THE SUBJECT UNDERWENT AV ACCESS CIRCUIT RE-INTERVENTION FOR STENOSIS OF RIGHT UPPER EXTREMITY AV FISTULA. REPORTEDLY, LUTONIX DRUG COATED BALLOON WAS USED IN RE-INTERVENTION FOR TARGET LESION ON CEPHALIC VEIN WITH INITIAL STENOSIS OF 90% AND FINAL RESIDUAL STENOSIS OF 30%. THE RE-INTERVENTION WAS SUCCESSFUL, AND THE CURRENT STATUS OF THE PATIENT WAS NOT PROVIDED.

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

  MAUDE report 20017132 ↗
• InjuryAug 5, 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 TWO MONTHS AND TWENTY DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER, THE SUBJECT HAD AN ADVERSE EVENT OF PROLONGED BLEEDING AND DIMINISHED BRUIT AND THRILL WHICH REQUIRED AN ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION. IT WAS FURTHER REPORTED THAT THE ADVERSE EVENT WAS NOT RELATED TO THE PROCEDURE AND DEVICE BUT DEFINITELY RELATED TO THE ARTERIOVENOUS ACCESS CIRCUIT. REPORTEDLY, STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, AND OTHER DRUG COATED BALLOON WAS USED FOR TREATMENT. THE RE-INTERVENTION WAS SUCCESSFUL, AND THE OUTCOME OF THE ADVERSE EVENT WAS RESOLVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Restenosis

  MAUDE report 19907425 ↗
• DeathMay 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 SOMETIME POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON DEVICE IN THE BASILIC VEIN AT PERIANASTOMOTIC VENOUS, THE SUBJECT DEVELOPED A SERIOUS ADVERSE EVENT OF LEFT ARM FISTULA WITH STENOSIS WHICH REQUIRED AN ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION. TREATMENT RE-INTERVENTION WAS SUCCESSFUL, NO NEW ACCESS CREATED, AND THE OUTCOME OF THE SERIOUS ADVERSE EVENT WAS RESOLVED. FURTHERMORE, LEFT ARM ANGIOPLASTY AND FISTULOGRAM WAS PERFORMED FOR NARROWING ARTERIAL ANASTOMOSIS. THE EVENT "LEFT ARM FISTULA WITH STENOSIS" WAS CONSIDERED NOT RELATED TO THE STUDY DEVICE AND PROCEDURE. HOWEVER, WAS DEFINITELY RELATED TO THE AV ACCESS CIRCUIT. THE EVENT "LEFT ARM ANGIOPLASTY AND FISTULOGRAM WAS PERFORMED FOR NARROWING ARTERIAL ANASTOMOSIS" WAS OF MODERATE SEVERITY AND WAS NOT RELATED TO THE STUDY DEVICE AND PROCEDURE; HOWEVER, WAS DEFINITELY RELATED TO AV ACCESS CIRCUIT. A REINTERVENTION "LEFT ARM BALLOON ANGIOPLASTY AND FISTULOGRAM" WAS PERFORMED FOR NARROWING BASILIC VEIN ANASTOMOSIS, WHICH WAS OF MODERATE SEVERITY AND WAS NOT RELATED TO THE STUDY DEVICE AND PROCEDURE; HOWEVER, WAS DEFINITELY RELATED TO AV ACCESS CI

  Patient problems: Fistula; Insufficient Information; Restenosis

  MAUDE report 19380722 ↗
• DeathMay 23, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT TWO MONTHS AND EIGHTEEN DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER, THE SUBJECT REPORTEDLY EXPIRED, AND THE PRIMARY CAUSE OF DEATH WAS NOT PROVIDED. REPORTEDLY, THERE HAVE BEEN NO DOCUMENTED DEVICE DEFICIENCIES, AND NO ADVERSE EVENTS WERE REPORTED, AND THE RELATIONSHIP OF THE DEATH WITH THE DEVICE, PROCEDURE AND AV ACCESS CIRCUIT WERE NOT PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19379098 ↗
• InjuryApr 10, 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 FIFTEEN DAYS POST AN INDEX PROCEDURE USING A DRUG COATED BALLOON CATHETER, THE SUBJECT HAD AN ADVERSE EVENT OF SEVERE STENOSIS OF ANASTOMOSIS AND JUXTA ANASTOMOTIC CEPHALIC VEIN AND WAS TREATED WITH AN STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. REPORTEDLY THE ADVERSE EVENT WERE NOT RELATED TO THE DEVICE, PROCEDURE BUT DEFINITELY RELATED TO AV ACCESS CIRCUIT. THE RE-INTERVENTION INVOLVED ON THE TARGET LESION WITH INITIAL STENOSIS OF 58% AND FINAL RESIDUAL STENOSIS OF 0% BY STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND LUTONIX DRUG COATED BALLOON. THE RE-INTERVENTION WAS SUCCESSFUL, NO NEW ACCESS CREATED AND THE OUTCOME WAS RESOLVED. REPORTEDLY, THE SUBJECT WAS EXPIRED AND THE CAUSE OF DEATH WAS NOT PROVIDED.

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

  MAUDE report 19077767 ↗
• InjuryApr 10, 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 ONE YEAR AND FIFTEEN DAYS POST INDEX PROCEDURE USING A DRUG COATED BALLOON CATHETER, THE SUBJECT HAD AN ADVERSE EVENT OF OCCLUSION OF BRACHIOCEPHALIC VEIN AND WAS TREATED WITH AN STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. IT WAS FURTHER REPORTED THAT FOUR MONTHS AND TWENTY SEVEN DAYS POST INDEX PROCEDURE, THE SUBJECT HAD AN ADVERSE EVENT OF RECURRENT OCCLUSION OF BRACHIOCEPHALIC VEIN AND WAS TREATED WITH AN STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. IT WAS FURTHER REPORTED THAT SIX MONTHS AND TWENTY ONE DAYS POST INDEX PROCEDURE, THE SUBJECT HAD AN ADVERSE EVENT OF RECURRENT STENOSIS OF BRACHIOCEPHALIC VEIN AND WAS TREATED WITH AN STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. REPORTEDLY THE ADVERSE EVENT WERE NOT RELATED TO THE DEVICE, PROCEDURE BUT DEFINITELY RELATED TO AV ACCESS CIRCUIT. ALL THE RE-INTERVENTION WAS SUCCESSFUL, NO NEW ACCESS CREATED AND THE OUTCOME WAS RESOLVED. THE CURRENT STATUS OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: Restenosis

  MAUDE report 19077735 ↗
• InjuryMar 8, 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 SEVENTEEN DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG COATED BALLOON CATHETER IN THE CEPHALIC VEIN, THE SUBJECT DEVELOPED A SERIOUS ADVERSE EVENT OF VASCULAR OCCLUSION DUE TO ACCESS THROMBOSIS WHICH REQUIRED AN ADDITIONAL ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION. THROMBECTOMY AND FISTULA LIGATION WERE PERFORMED TO TREAT ACCESS THROMBOSIS. TREATMENT RE-INTERVENTION WAS NOT SUCCESSFUL DUE TO ABANDONED ACCESS. FURTHERMORE, A NEW ACCESS WAS CREATED USING PERMANENT DIALYSIS CATHETER DUE TO REASSESSMENT NEED FOR CENTRAL VENOUS CATHETER. REPORTEDLY, THERE HAVE BEEN NO DOCUMENTED DEVICE DEFICIENCIES REPORTED FOR THIS SUBJECT TO DATE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Restenosis; Thrombosis/Thrombus

  MAUDE report 18867449 ↗
• InjuryFeb 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 SEVEN MONTHS AND SIXTEEN DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER, THE SUBJECT HAD AN ADVERSE EVENT OF THROMBOSED LEFT ARTERIOVENOUS FISTULA AND WAS TREATED WITH STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, THROMBECTOMY, STENT GRAFT AND SURGICAL REVISION. IT WAS FURTHER REPORTED THAT ONE YEAR, ONE MONTH AND NINETEEN DAYS POST INDEX PROCEDURE, THE SUBJECT HAD ADVERSE EVENT OF HIGH VENOUS PRESSURE WITH ANEURYSMAL DILATATION WHICH REQUIRED ADDITIONAL INTERVENTION. REPORTEDLY THE ADVERSE EVENT WERE NOT RELATED TO THE DEVICE, PROCEDURE BUT DEFINITELY RELATED TO AV ACCESS CIRCUIT. STANDARD PERCUTANEOUS ANGIOPLASTY WAS USED FOR TREATMENT. THE RE-INTERVENTION WAS SUCCESSFUL, NO NEW ACCESS CREATED AND THE OUTCOME WAS RESOLVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Aneurysm; Restenosis

  MAUDE report 18768611 ↗
• InjuryJan 11, 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 TWO MONTHS AND TWENTY-SEVEN DAYS POST INDEX PROCEDURE USING A DRUG COATED BALLOON CATHETER IN THE CEPHALIC VEIN AT CEPHALIC ARCH, THE SUBJECT DEVELOPED A SERIOUS ADVERSE EVENT OF STENOSIS IN CEPHALIC ARCH AND SUBCLAVIAN VEIN IN ARTERIOVENOUS FISTULA WHICH REQUIRED ADDITIONAL ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION. IT WAS FURTHER REPORTED THAT THE TARGET LESION HAD NINETY PERCENT INITIAL STENOSIS AND ZERO PERCENT FINAL RESIDUAL STENOSIS. IT WAS ALSO REPORTED THAT THE NEW LESION WITHIN THE ACCESS CIRCUIT HAD NINETY PERCENT INITIAL STENOSIS AND THIRTY PERCENT FINAL RESIDUAL STENOSIS. STANDARD PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY PROCEDURE WAS PERFORMED TO TREAT RESTENOSIS. THE TREATMENT RE-INTERVENTION WAS SUCCESSFUL, AND SO A NEW ACCESS WAS NOT CREATED. REPORTEDLY, THE OUTCOME OF SERIOUS ADVERSE EVENT WAS RESOLVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 18490710 ↗
• InjuryDec 14, 2023Adverse 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 ONE YEAR AND FIFTEEN DAYS POST ANGIOPLASTY PROCEDURE, THE PATIENT DIAGNOSED WITH RESTENOSIS. IT WAS FURTHER REPORTED THAT STANDARD PTA WAS PERFORMED TO TREAT THE TARGET LESION. THE CURRENT STATUS OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: Restenosis

  MAUDE report 18325248 ↗
• InjuryDec 7, 2023Adverse 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 POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER, IN THE CEPHALIC VEIN ARCH, THE SUBJECT HAD AN ADVERSE EVENT OF OCCLUSION OF CEPHALIC ARCH IN THE ARTERIOVENOUS FISTULA AND ALLEGEDLY EXPERIENCED TARGET LESION RESTENOSIS. STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED TO TREAT THE TARGET LESION. IT WAS FURTHER REPORTED THAT APPROXIMATELY SEVEN MONTHS POST INDEX PROCEDURE, THE PATIENT HAD AN ADVERSE EVENT OF ARTERIOVENOUS FISTULA MALFUNCTION AND PERMA CATH WAS PLACED. THE ADVERSE EVENT RELATIONSHIP WAS NOT RELATED TO THE DEVICE, PROCEDURE BUT RELATED TO AV ACCESS CIRCUIT. IT WAS ALSO REPORTED THAT APPROXIMATELY SEVEN MONTHS POST INDEX PROCEDURE, THE SUBJECT HAD AN ADVERSE EVENT OF SUPERIOR VENA CAVA SYNDROME THAT RESULTS IN AN AV ACCESS CIRCUIT RE-INTERVENTION. THE ADVERSE EVENT RELATIONSHIP WAS NOT RELATED TO DEVICE, PROCEDURE BUT RELATED TO AV ACCESS CIRCUIT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Obstruction/Occlusion; Restenosis

  MAUDE report 18280468 ↗
• InjuryNov 28, 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 TWO MONTHS AND TWENTY-FIVE DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN THE CEPHALIC VEIN ARCH, THE SUBJECT HAD AN ADVERSE EVENT OF LOW ACCESS FLOW WITH OCCURRENCE OF RESTENOSIS OF THE TARGET LESION AND REQUIRED AN ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS IN THE UPPER ARM WITH EIGHTY PERCENT INITIAL STENOSIS AND NINETEEN PERCENT FINAL RESIDUAL STENOSIS. REPORTEDLY, STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS USED FOR TREATMENT. THE RE-INTERVENTION WAS SUCCESSFUL, AND THE OUTCOME OF THE ADVERSE EVENT WAS RESOLVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Aneurysm; Chest Pain; Restenosis; Swelling/ Edema

  MAUDE report 18214063 ↗
• InjuryOct 21, 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 FIVE MONTHS AND TWENTY-TWO DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN THE CEPHALIC VEIN, THE SUBJECT DEVELOPED A SERIOUS ADVERSE EVENT OF RESTENOSIS OF THE CEPHALIC VEIN IN THE TARGET LESION WHICH REQUIRED AN ARTERIOVENOUS ACCESS CIRCUIT RE-INTERVENTION. IT WAS FURTHER REPORTED THAT THE TARGET LESION IN THE LEFT FOREARM HAD FIFTY-SEVEN PERCENT INITIAL STENOSIS AND NINE PERCENT FINAL RESIDUAL STENOSIS. FURTHERMORE, STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE WAS PERFORMED FOR THE TREATMENT. REPORTEDLY, THE TREATMENT RE-INTERVENTION WAS SUCCESSFUL, A NEW ACCESS WAS NOT CREATED, AND THE OUTCOME OF SERIOUS ADVERSE EVENT WAS RESOLVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 17981778 ↗
• InjuryAug 8, 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 NINE MONTHS AND FOUR DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN CEPHALIC VEIN, THE SUBJECT DEVELOPED AN ADVERSE EVENT OF MALFUNCTIONING FISTULA DUE TO AN ELEVATED VENOUS PRESSURES WHICH REQUIRED PROLONGED HOSPITALIZATION AND AN ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION. IT WAS FURTHER REPORTED THAT ABOUT ELEVEN MONTHS AND SIXTEEN DAYS POST INDEX PROCEDURE, THE SUBJECT DEVELOPED AN ADVERSE EVENT OF MALFUNCTIONING FISTULA WHICH REQUIRED AN ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION. STANDARD PERCUTANEOUS TRANSLUMINOUS ANGIOPLASTY WAS USED FOR TREATMENT AND THE REINTERVENTION WAS SUCCESSFUL. IT WAS ALSO REPORTED THAT ABOUT ELEVEN MONTHS AND THIRTY DAYS POST INDEX PROCEDURE, THE SUBJECT HAD AN ADVERSE EVENT OF MALFUNCTIONING FISTULA AND UNDERWENT ACCESS CIRCUIT REINTERVENTION DUE TO AN ACCESS THROMBOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Restenosis; Thrombosis/Thrombus

  MAUDE report 17480092 ↗