LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575760VRecalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00801741135439), received between Feb 28, 2018 and Dec 15, 2025 — classified as 2 deaths, 52 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 25 most recent of 60 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 ((B)(6)) THAT APPROXIMATELY SIXTEEN DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER, THE SUBJECT HAD AN ADVERSE EVENT OF ¿LEFT AVF BASILIC VEIN STENOSIS¿. REPORTEDLY, THE ADVERSE EVENT WAS RELATED TO DEVICE AND AV ACCESS CIRCUIT BUT NOT RELATED TO THE PROCEDURE. IT WAS FURTHER REPORTED THAT A STANDARD PTA AND LUTONIX DCB WAS USED DURING RE-INTERVENTION IN THE TARGET LESION ON BASILIC VEIN WITH INITIAL STENOSIS OF 60% AND FINAL RESIDUAL STENOSIS OF 20%. THE RE-INTERVENTION WAS SUCCESSFUL AND NO NEW ACCESS WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 23800470 ↗
• InjurySep 22, 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 (AV PAS) THAT SEVEN MONTHS AND FIVE DAYS LATER POST PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE BY USING LUTONIX DILATION CATHETER ON THE LEFT FOREARM CEPHALIC VEIN PERIANASTOMOTIC VENOUS STENOSIS, THE SUBJECT HAD AN ADVERSE EVENT OF ANGIOGRAM DUE TO STENOSIS OF LEFT RADIOCEPHALIC AVF. IT WAS FURTHER REPORTED THAT THE ADVERSE EVENT WAS NOT RELATED TO DEVICE AND PROCEDURE BUT DEFINITELY RELATED TO AV ACCESS CIRCUIT. REPORTEDLY, A AV ACCESS CIRCUIT RE-INTERVENTION WAS PERFORMED ON THE TARGET LESION ON CEPHALIC VEIN WITH INITIAL STENOSIS OF 58% AND FINAL RESIDUAL STENOSIS OF 25%. THE RE-INTERVENTION WAS SUCCESSFUL AND NO NEW ACCESS CREATED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 23106994 ↗
• MalfunctionSep 10, 2025Material Rupture; Material Rupture

  A PATIENT UNDERWENT A ANGIOPLASTY PROCEDURE USING THE LUTONIX 035AV DRUG COATED BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY GOT BURST. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23013186 ↗
• DeathSep 5, 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 DILATION CATHETER ON THE BASILIC VEIN OF THE LEFT UPPER ARM FOR DILATION OF STENOSIS, THE SUBJECT EVENTUALLY EXPIRED, DUE TO END STAGE RENAL DISEASE. THE CAUSE OF DEATH WAS NOT REPORTED AND RELATIVITY OF THE EVENT WITH THE DEVICE OR PROCEDURE IS NOT REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22975409 ↗
• 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 THE CLINICAL TRAIL OF A LUTONIX BALLOON, THAT APPROXIMATELY FIVE MONTHS AND TWENTY-TWO DAYS POST THE PTA PROCEDURE, THE PATIENT HAD DECREASED FLOW RATE ON THE ACCESS CIRCUIT. IT WAS ALSO REPORTED THAT STENOSIS WAS IDENTIFIED ON THE TARGET LESION AND ALSO A NEW LESION WAS IDENTIFIED. THE REPORTED EVENT WAS NOT RELATED TO THE DEVICE OR PROCEDURE. THE PATIENT UNDERWENT A PTA PROCEDURE AS RE-INTERVENTION FOR THE STENOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Reduced Blood Flow; Restenosis

  MAUDE report 22791413 ↗
• InjuryJul 1, 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 (CL003301) THAT SOMETIME LATER POST PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE BY USING LUTONIX DILATION CATHETER ON THE BASILIC VEIN OF THE RIGHT UPPER ARM FOR DILATION OF STENOSIS, THE SUBJECT HAD RESTENOSIS OF THE TARGET VEIN AND THROMBOSIS. HOWEVER, THE EVENT RELATEDNESS TO THE DEVICE AND STUDY WERE NOT PROVIDED.

  Patient problems: Restenosis; Thrombosis/Thrombus

  MAUDE report 22370905 ↗
• InjuryApr 18, 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 SIX MONTHS AND ELEVEN DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN THE RIGHT UPPER ARM CEPHALIC VEIN, THE SUBJECT HAD AN ADVERSE EVENT OF THROMBOSED FISTULA. REPORTEDLY, THE ADVERSE EVENT WAS NOT RELATED TO DEVICE AND RESULT IN RE-INTERVENTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21865276 ↗
• 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 TWO WEEKS FIVE DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN THE CEPHALIC VEIN, THE SUBJECT HAD AN ADVERSE EVENT OF LEFT UPPER EXTREMITY AVF MALFUNCTION AND TARGET LIMB LEFT UPPER EXTREMITY FISTULOGRAM WITH REVISION. REPORTEDLY, THE ADVERSE EVENT WAS POSSIBLY RELATED TO STUDY DEVICE AND STUDY PROCEDURE AND 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 ELEVATED VENOUS PRESSURE. FURTHERMORE, A DRUG COATED BALLOON AND SURGICAL REVISION OF LEFT CEPHALIC VENOPLASTY WAS PERFORMED DURING RE-INTERVENTION ON THE TARGET LESION 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: Aneurysm; Restenosis

  MAUDE report 21823089 ↗
• InjuryMar 20, 2025Restricted Flow rate; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Restricted Flow rate; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY EIGHT MONTHS AND THREE DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN THE BRACHIAL VEIN TARGET LESION, THE SUBJECT HAD AN ADVERSE EVENT OF LOW ACCESS AND DIFFICULT CANNULATION DUE TO TOTAL OCCLUSION. 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 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: Embolism/Embolus; Obstruction/Occlusion; Restenosis; Thrombosis/Thrombus

  MAUDE report 21649759 ↗
• DeathMar 4, 2025Adverse 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 FIVE MONTHS AND ELEVEN DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER FOR TARGET LESION STENOSIS IN THE LEFT UPPER ARM BASILIC VEIN, THE SUBJECT HAD AN ADVERSE EVENT OF DEATH OF UNKNOWN CAUSE. THE PRIMARY CAUSE OF DEATH WAS UNKNOWN. REPORTEDLY, THE DEATH WAS NOT RELATED TO STUDY DEVICE, PROCEDURE, AND ARTERIOVENOUS ACCESS CIRCUIT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21512199 ↗
• InjuryFeb 26, 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 ONE YEAR, TEN MONTHS AND TWENTY-ONE DAYS POST AN INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN THE CEPHALIC VEIN, THE SUBJECT HAD AN ADVERSE EVENT OF PROLONGED BLEEDING. 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 AV ACCESS CIRCUIT RE-INTERVENTION IN THE TARGET LESION ON LEFT UPPER ARM FOR PROLONGED BLEEDING. FURTHERMORE, A DRUG COATED BALLOON WAS USED IN RE-INTERVENTION ON THE TARGET LESION AND THE RE-INTERVENTION WAS SUCCESSFUL. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Restenosis

  MAUDE report 21466468 ↗
• InjuryFeb 3, 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 FOUR WEEKS POST AN INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN THE LEFT ARM CEPHALIC VEIN STENOSIS, THE SUBJECT HAD AN ADVERSE EVENT OF FISTULA REVISION DUE TO DECREASE ACCESS BLOOD FLOW. 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 OF SURGICAL REVISION FOR DECREASED ACCESS BLOOD FLOW, DECREASED DIALYSIS DOSE, DIMINISHED OR ABNORMAL THRILL AND PULSATILITY. REPORTEDLY, THE RE-INTERVENTION WAS SUCCESSFUL. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Restenosis; Thrombosis/Thrombus

  MAUDE report 21291919 ↗
• InjuryJan 2, 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 FIVE MONTHS AND FOUR DAYS POST AN INDEX PROCEDURE USING A DRUG COATED BALLOON CATHETER, THE SUBJECT DEVELOPED AN ADVERSE EVENT OF INCREASED BLEEDING IN THE FISTULA. REPORTEDLY, THE ADVERSE EVENT RESULTS IN AV ACCESS CIRCUIT RE-INTERVENTION AND THE ADVERSE EVENT RELATIONSHIP DETAILS WERE NOT PROVIDED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Restenosis

  MAUDE report 21052410 ↗
• InjuryNov 27, 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 APPROXIMATELY TWO DAYS POST AN INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN THE RIGHT ARM CEPHALIC VEIN, THE SUBJECT HAD AN ADVERSE EVENT OF SURGICAL ARTERIOVENOUS FISTULA DECLOTTING THROMBECTOMY AND GRAFT REVIEW DUE TO THROMBOSED GRAFT AND STENOSIS. IT WAS FURTHER REPORTED THAT THE ADVERSE EVENT WAS NOT RELATED TO STUDY DEVICE AND STUDY PROCEDURE BUT DEFINITELY RELATED TO ARTERIOVENOUS ACCESS CIRCUIT. REPORTEDLY, ARTERIOVENOUS ACCESS CIRCUIT RE-INTERVENTION WAS PERFORMED ON THE TARGET RIGHT ARM FOR ACCESS THROMBOSIS. FURTHERMORE, THROMBECTOMY/THROMBOLYSIS AND SURGICAL REVISION WAS PERFORMED IN RE-INTERVENTION AND THE RE-INTERVENTION WAS SUCCESSFUL. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Restenosis; Stenosis; Thrombosis/Thrombus; Wound Dehiscence

  MAUDE report 20793799 ↗
• InjuryNov 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 APPROXIMATELY THREE MONTHS AND ELEVEN DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER, THE SUBJECT HAD AN ADVERSE EVENT OF STENOSIS WHICH REQUIRED RE-INTERVENTION. THE ADVERSE EVENT STENOSIS OF CEPHALIC ARCH IN ARTERIOVENOUS FISTULA WAS NOT RELATED TO THE STUDY DEVICE AND STUDY PROCEDURE. HOWEVER, THE ADVERSE EVENT WAS POSSIBLY RELATED TO THE ARTERIOVENOUS ACCESS CIRCUIT. THE RE-INTERVENTION WAS SUCCESSFUL, AND THE OUTCOME OF THE ADVERSE EVENT WAS RESOLVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bradycardia; Restenosis; Stenosis

  MAUDE report 20766280 ↗
• InjuryNov 4, 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 POST ANGIOPLASTY PROCEDURE, THE PATIENT ALLEGEDLY DEVELOPED LEFT AVF BASILIC VEIN STENOSIS. IT WAS FURTHER REPORTED THAT PTA AND DCB WERE USED ON AS REINTERVENTION ON BASILIC VEIN STENOSIS AT THE ANASTOMOTIC LOCATION. THE ADVERSE EVENT WAS NOT RELATED TO THE STUDY DEVICE AND PROCEDURE. HOWEVER, WAS DEFINITELY RELATED TO THE AV ACCESS CIRCUIT. THE CURRENT STATUS OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: Stenosis; Thrombosis/Thrombus

  MAUDE report 20597826 ↗
• InjuryOct 7, 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 APPROXIMATELY ONE MONTHS AND FOURTEEN 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 RESISTANT STENOSIS IN THE BRACHIAL CEPHALIC ARTERIOVENOUS FISTULA. 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, ON THE SAME DAY, TARGET LESION RE-INTERVENTION WAS PERFORMED BY USING STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND OTHER DRUG COATED BALLOON WITH INITIAL STENOSIS OF 90% AND FINAL RESIDUAL STENOSIS OF 0%. IT WAS FURTHER REPORTED THAT APPROXIMATELY THREE MONTHS AND TWENTY ONE DAYS POST INDEX PROCEDURE, THE SUBJECT HAD AN ADVERSE EVENT OF DIFFICULT CANNULATION DUE TO STENOSIS. REPORTEDLY, THE ADVERSE EVENT WAS NOT RELATED TO DEVICE AND PROCEDURE BUT DEFINITELY RELATED TO AV ACCESS CIRCUIT. FURTHERMORE, THE SUBJECT UNDERWENT RE-INTERVENTION INVOLVED ON THE TARGET LESION WITH INITIAL STENOSIS OF 50% AND FINAL RESIDUAL STENOSIS OF 29%. REPORTEDLY, THE RE-INTERVENTION WAS SUCCESSFUL AND THE CURREN

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Restenosis

  MAUDE report 20392700 ↗
• InjuryAug 22, 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 APPROXIMATELY ONE YEAR TWO MONTHS AND ONE DAY POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER, THE SUBJECT DEVELOPED ADVERSE EVENT OF STENOSIS OF CEPHALIC VEIN WHICH REQUIRED REINTERVENTION. REPORTEDLY, THE ADVERSE EVENT WAS NOT RELATED TO THE STUDY DEVICE AND STUDY PROCEDURE BUT DEFINITELY RELATED TO THE AV ACCESS CIRCUIT. FURTHERMORE, THE ADVERSE EVENT WAS TREATED WITH STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND ANOTHER LUTONIX DRUG COATED BALLOON. IT WAS FURTHER REPORTED THAT APPROXIMATELY ONE YEAR ELEVEN MONTHS AND NINE DAYS POST INDEX PROCEDURE, THE SUBJECT DEVELOPED AN ADVERSE EVENT OF RE-INTERVENTION OF PROXIMAL OUTFLOW CEPHALIC VEIN WHICH REQUIRED RE-INTERVENTION. REPORTEDLY, THE ADVERSE EVENT WAS NOT RELATED TO THE STUDY DEVICE AND STUDY PROCEDURE BUT DEFINITELY RELATED TO THE AV ACCESS CIRCUIT. FURTHERMORE, THE ADVERSE EVENT WAS TREATED WITH STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, STENT GRAFT AND OTHER DRUG COATED BALLOON ON THE TARGET LESION WITH INITIAL STENOSIS OF 51% AND FINAL RESIDUAL STENOSIS OF 4%. THE RE-INTERVENTION WAS SUCCESSFUL. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 20030387 ↗
• InjuryAug 14, 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 ELEVEN MONTHS AND TWENTY DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER IN THE CEPHALIC VEIN VIA THE LEFT FOREARM AT OUTFLOW NEAR CANNULATION ZONE, THE SUBJECT ALLEGEDLY HAD AN ADVERSE EVENT OF RE-INTERVENTION OF JUXTA-ANASTOMOTIC SEGMENT DUE TO STENOSIS AND REQUIRED AN ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS IN THE FOREARM WITH SEVENTY-THREE PERCENT INITIAL STENOSIS AND FORTY-SEVEN PERCENT FINAL RESIDUAL STENOSIS. REPORTEDLY, STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND OTHER DRUG COATED BALLOON CATHETER 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: Restenosis

  MAUDE report 19980566 ↗
• InjuryJul 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 FOUR MONTHS AND THIRTY DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER IN THE CEPHALIC VEIN AT OUTFLOW NEAR CANNULATION ZONE VIA THE LEFT UPPER ARM, THE SUBJECT DEVELOPED A SERIOUS ADVERSE EVENT OF INCREASED BLEEDING IN FISTULA WHICH REQUIRED AN ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION. IT WAS FURTHER REPORTED THAT THE ARTERIOVENOUS ACCESS CIRCUIT RE-INTERVENTION WAS PERFORMED ON THE TARGET LESION CEPHALIC VEIN WITH INITIAL STENOSIS OF EIGHTY PERCENT AND FINAL RESIDUAL STENOSIS OF TEN PERCENT. FURTHERMORE, THE TREATMENT RE-INTERVENTION WAS SUCCESSFUL AND THE OUTCOME OF THE SERIOUS ADVERSE EVENT WAS RESOLVED. MOREOVER, APPROXIMATELY SEVEN MONTHS AND ONE DAY AFTER INDEX PROCEDURE, THE SUBJECT HAD ANOTHER SERIOUS ADVERSE EVENT OF PROLONGED BLEEDING WHICH REQUIRED AN ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION. APPARENTLY, ARTERIOVENOUS ACCESS CIRCUIT RE-INTERVENTION WAS PERFORMED ON THE TARGET LESION CEPHALIC VEIN WITH INITIAL STENOSIS OF SIXTY PERCENT AND FINAL RESIDUAL STENOSIS OF TWENTY PERCENT. EVIDENTLY, THE RE-INTERVENTION WAS SUCCESSFUL AND THE OUTCOME OF SERIOUS ADVERSE EVENT WAS RESOL

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Restenosis

  MAUDE report 19719330 ↗
• InjuryJul 9, 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 SEVEN DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER, THE SUBJECT HAD AN ADVERSE EVENT OF PROLONGED BLEEDING AND 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 ZERO 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. IT WAS FURTHER REPORTED THAT PATIENT WAS EXPIRED AND THE EVENT WAS NOT RELATED TO DEVICE, PROCEDURE AND AV ACCESS CIRCUIT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Restenosis

  MAUDE report 19699106 ↗
• InjuryApr 15, 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 MONTH AND TWELVE DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER IN THE AXILLARY VEIN AT ANASTOMOTIC, THE SUBJECT HAD SERIOUS ADVERSE EVENT OF THROMBOSIS OF THE POLYTETRAFLUOROETHYLENE PROSTHESIS IN THE ARTERIOVENOUS FISTULA OF THE RIGHT ARM DUE TO ACCESS THROMBOSIS WHICH REQUIRED AN ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION. IT WAS FURTHER REPORTED THAT ONE MONTH AND THIRTEEN DAYS POST AN INDEX PROCEDURE COMPLETION, STANDARD PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY PROCEDURE AND RECANALIZATION PROCEDURE WITH THROMBECTOMY OF THE POLYTETRAFLUOROETHYLENE PROSTHESIS IN THE ARTERIOVENOUS FISTULA WERE PERFORMED TO TREAT ACCESS THROMBOSIS. TREATMENT RE-INTERVENTION WAS SUCCESSFUL, NO NEW ACCESS CREATED, AND THE OUTCOME OF SERIOUS ADVERSE EVENT WAS RESOLVED. IT WAS ALSO REPORTED THAT THREE MONTHS AND THREE DAYS POST AN INDEX PROCEDURE COMPLETION, THE SUBJECT DEVELOPED A SERIOUS ADVERSE EVENT OF ANGIOPLASTY OF A BRACHIO-AXILLARY GORE-TEX FISTULA FOR DISTAL ANASTOMOTIC STENOSIS AND GORE-TEX STENOSIS DUE TO DECREASED ACCESS BLOOD FLOW WHICH REQUIRED AN ARTERIOVENOUS ACCESS CIRCUIT REINTERVENT

  Patient problems: Restenosis; Thrombosis/Thrombus

  MAUDE report 19103541 ↗
• InjuryApr 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 SIX MONTHS AND SEVEN DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER, THE SUBJECT HAD AN ADVERSE EVENT 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 ZERO 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. IT WAS FURTHER REPORTED THAT PATIENT WAS EXPIRED AND THE EVENT WAS NOT RELATED TO DEVICE, PROCEDURE AND AV ACCESS CIRCUIT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Restenosis

  MAUDE report 19057472 ↗
• InjuryApr 4, 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 EIGHT MONTHS AND EIGHT DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER IN THE CEPHALIC VEIN, THE SUBJECT DEVELOPED A SERIOUS ADVERSE EVENT OF REINTERVENTION OF STUDY ARTERIOVENOUS FISTULA AT THE CANNULATION ZONE AND PERIANASTOMOTIC VENOUS DUE TO DECREASED ACCESS BLOOD FLOW WHICH REQUIRED AN ADDITIONAL ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION. IT WAS FURTHER REPORTED THAT STANDARD PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY PROCEDURE WAS PERFORMED TO TREAT DECREASED ACCESS BLOOD FLOW. TREATMENT RE-INTERVENTION WAS SUCCESSFUL, NO NEW ACCESS CREATED, AND THE OUTCOME OF THE SERIOUS ADVERSE EVENT WAS RESOLVED. 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

  MAUDE report 19039188 ↗
• InjuryFeb 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 WEEK AND TWO DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER IN THE BASILIC VEIN, THE SUBJECT DEVELOPED A SERIOUS ADVERSE EVENT OF ARM SWELLING DUE TO A HEMATOMA WHICH NECESSITATED MEDICAL INTERVENTION. IT WAS FURTHER REPORTED THAT EIGHT MONTHS POST AN INDEX PROCEDURE COMPLETION, THE SUBJECT DEVELOPED A SERIOUS ADVERSE EVENT OF DYSFUNCTIONAL ARTERIOVENOUS FISTULA PERITONITIS WHEN PATIENT TRANSITIONED FROM PERITONEAL DIALYSIS TO HEMODIALYSIS WHICH REQUIRED AN ADDITIONAL ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION. IT WAS ALSO REPORTED THAT THE BASILIC VEIN IN THE LEFT UPPER ARM HAD AN INITIAL STENOSIS OF NINETY PERCENT AND NINETEEN PERCENT FINAL RESIDUAL STENOSIS. FURTHERMORE, THE TARGET LESION IN THE LEFT UPPER ARM WAS TREATED WITH STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER. THE TREATMENT RE-INTERVENTION WAS SUCCESSFUL, AND SO A NEW ACCESS WAS NOT CREATED. REPORTEDLY, THE OUTCOME OF THE SERIOUS ADVERSE EVENT WAS RESOLVED. EVIDENTLY, THERE HAVE BEEN NO DOCUMENTED DEVICE DEFICIENCIES REPORTED FOR THIS SUBJECT TO DATE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hematoma; Peritonitis; Restenosis

  MAUDE report 18638464 ↗