Ranger™ H74939419502010Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 08714729976042), received between Nov 12, 2021 and Nov 25, 2025 — classified as 46 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (14 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE ELUVIA DRUG ELUTING STENT AND RANGER DRUG COATED BALLOON ON (B)(6) 2023 AS A PART OF THE CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, LEFT MID SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO LEFT DISTAL SUPERFICIAL FEMORAL ARTERY WITH 3.9 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 4.5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 172 MM WITH 100 % STENOSIS AND WAS CLASSIFIED AS TASC II C LESION. PRIOR TO THE TREATMENT OF TARGET LESION WITH STUDY DEVICES, PRE-DILATION WAS PERFORMED USING 4 MM X 220 MM STERLING PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY USING STUDY DEVICES, 6 MM X 60 MM ELUVIA DRUG ELUTING STENT AND 5 MM X 200 MM RANGER DRUG COATED BALLOON. FOLLOWING TREATMENT, POST-DILATION WAS PERFORMED USING 5 MM X 60 MM STERLING PTA BALLOON. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY OF INDEX PROCEDURE, DISSECTION OF GRADE A WAS NOTED DUE TO 0.018 X 135 CM RUBICON CATHETER. IN RESPONSE TO THE COMPLICATION, BALLOON DILATION AND BAILOUT STENTING WAS PERFORMED. POST TREATMENT, THE FINAL RES

  Patient problems: Vascular Dissection

  MAUDE report 23647194 ↗
• MalfunctionNov 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION, EXHIBITING 90% OR GREATER STENOSIS, WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED DISTAL SUPERFICIAL FEMORAL ARTERY EXTENDING TO THE POPLITEAL ARTERY. A 5.0 X 200 MM, 150 CM RANGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INITIAL INFLATION AT 13 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23548287 ↗
• MalfunctionOct 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 5.0 X 200MM, 150CM RANGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 6 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300464 ↗
• MalfunctionSep 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 200MM, 150CM RANGER DRUG-COATED BALLOON WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR 3 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23067996 ↗
• MalfunctionSep 15, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED DEVICE GOT STUCK WITH THE GUIDEWIRE. THE STENOSED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 5.0MM X 200MM, 150CM RANGER BALLOON CATHETER WAS SELECTED FOR USE. DURING PROCEDURE, THE DEVICE GOT STUCK WITH THE GUIDEWIRE AND WAS REMOVED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058153 ↗
• MalfunctionAug 4, 2025Material Puncture/Hole; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Material Puncture/Hole; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WIRE BROKE THROUGH BALLOON MATERIAL OCCURRED. THE 80% STENOSED, 200MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED PERIPHERAL ARTERY. A 5.0 X 200MM, 150CM RANGER (DCB) DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER AND A V-18 CONTROL WIRE WERE SELECTED FOR USE. PRE-DILATATION WAS PERFORMED PRIOR TO USE OF THE BALLOON. DURING THE PROCEDURE, IT WAS NOTED THAT THE WIRE BROKE AND COMING OUT THROUGH THE BALLOON. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22702193 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DISSECTION OCCURRED, REQUIRING INTERVENTION. ON (B)(6) 2024, THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS AS A PART OF THE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), LEFT MID SFA EXTENDING UP TO LEFT DISTAL SFA WITH 50 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 40 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 250 MM WITH 90% STENOSIS AND WAS CLASSIFIED AS TASC II C LESION. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 5 MM X 200 MM RANGER DRUG COATED BALLOON, STUDY DEVICE. A DISSECTION OF GRADE B WAS NOTED IN THE LEFT SFA DUE TO THE 5 MM X 200 MM RANGER DRUG COATED BALLOON. IN RESPONSE TO THE DISSECTION, A 6 MM X 40 MM INNOVA STENT WAS PLACED. FOLLOWING TREATMENT, A 60 MM X 80 MM INNOVA BARE METAL STENT WAS ALSO PLACED, AND FINAL RESIDUAL STENOSIS WAS NOTED TO BE 30%. ON THE SAME DAY, THE EVENT WAS CONSIDERED TO BE RESOLVED, AND THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Vascular Dissection

  MAUDE report 22039234 ↗
• MalfunctionMar 13, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT SHAFT HOLE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED SUPERFICIAL FEMORAL ARTERY RESTENOSIS. A 5.0 X 200MM, 150CM RANGER DRUG-COATED BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, A LEAK WAS NOTED TO BE CAUSED BY THE BACK END OF THE V-18 GUIDEWIRE PERFORATING THE INFLATION LUMEN FROM THE WIRE LUMEN WHILE BEING PASSED OVER THE WIRE WHEN REINSERTED FOR SUBSEQUENT INFLATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21598638 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DISSECTION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON AND ELUVIA DRUG ELUTING STENT ON (B)(6) 2024 AS A PART OF THE CLINICAL TRIAL. THE TARGET LESION WAS IN LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, LEFT MID SUPERFICIAL FEMORAL ARTERY, AND LEFT DISTAL SUPERFICIAL FEMORAL ARTERY, WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER WITH 250 MM LESION LENGTH AND 99% STENOSIS AND WAS CLASSIFIED AS TASC II C LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICES, ATHERECTOMY WAS PERFORMED USING A NON-BOSTON SCIENTIFIC (BSC) ATHERECTOMY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 5 MM X 200 MM RANGER DRUG-COATED BALLOON AND PLACEMENT OF 6 MM X 120 MM ELUVIA DRUG ELUTING STENT, STUDY DEVICES. FOLLOWING, ATHERECTOMY WAS PERFORMED USING NON-BSC DEVICE AND POST-DILATION WAS PERFORMED USING 6 MM X 120 MM ARMADA PTA BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%. ON (B)(6) 2024, ON THE SAME DAY OF INDEX PROCEDURE, POST USAGE OF 5 MM X 200 MM RANGER DRUG COATED BALLOON STUDY DEVICE, ANGIOGRAPHY REVEALED SEVERE FLOW LIMITING DISSECTION OF GRADE B IN LEF

  Patient problems: Vascular Dissection

  MAUDE report 21378512 ↗
• MalfunctionDec 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ARTERIAL FLOW TO SLOW OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 200MM, 150CM RANGER DRUG ELUTING PERIPHERAL BALLON WAS SELECTED FOR USE. DURING THE PROCEDURE, AFTER TREATING A VESSEL, DYE INJECTION IS PERFORMED TO ASSESS BLOOD FLOW SPEED. AT TIMES, POST-TREATMENT BLOOD FLOW APPEARS SLOWER. THIS SLOW FLOW IS TYPICALLY OBSERVED THROUGHOUT THE VESSEL PROXIMAL TO, WITHIN, AND DISTAL TO THE LESION. THE PHENOMENON WAS NOTICED FOLLOWING THE REMOVAL OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THERE ARE GENERALLY COMORBIDITIES PRESENT AND THE USUAL MEDICATIONS GIVEN ARE HEPARIN, VERSED AND FENTANYL.

  Patient problems: Obstruction/Occlusion; Vasoconstriction

  MAUDE report 20989484 ↗
• MalfunctionOct 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 200MM, 150CM RANGER (DCB) DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 6 ATMOSPHERES FOR 5 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20564701 ↗
• MalfunctionJul 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 200MM, 150CM RANGER DRUG-COATED BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19675326 ↗
• MalfunctionJun 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 200MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, ON THE FIRST INFLATION AT 6 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT A PROBLEM AND NO DAMAGED NOTED; HOWEVER, THE RUPTURE WAS FOUND TO BE IN THE SHAPE OF A PINHOLE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19606085 ↗
• MalfunctionMay 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED STRAIGHT SUPERFICIAL FEMORAL ARTERY. PRE-DILATION WAS PERFORMED AND A 5.0 X 200MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR DILATION OF THE LESION. A LOADING TOOL USED WHEN ADVANCING THROUGH THE SHEATH. DURING THE PROCEDURE, ON THE FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON LEAKED OUT WHEN IT WAS INFLATED AND A RUPTURE WAS CONFIRMED. THE DEVICE WAS SUCCESSFULLY REMOVED. THE POSITION OF THE RUPTURE WAS FOUND ON THE BALLOON PROXIMAL SIDE NEAR THE SHAFT. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19373939 ↗
• InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CLAUDICATION AND VESSEL OCCLUSION OCCURRED. ON (B)(6) 2024, PATIENT WAS PRESENTED WITH BILATERAL LOWER EXTREMITY CLAUDICATION. THE ENTIRE LENGTH OF THE LEFT COMMON FEMORAL, SUPERFICIAL FEMORAL AND POPLITEAL ARTERIES WAS TREATED WITH A ROTABLATOR ATHERECTOMY AND DONE WITHOUT COMPLICATIONS. PATIENT WAS IN A SUPINE POSITION UNDER LOCAL INFILTRATIVE ANESTHESIA. A 5.0 X 200MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED AND PASSED TO COVER THE DISTAL POPLITEAL ARTERY AND THE ENTIRE LENGTH OF THE POPLITEAL, SUPERFICIAL FEMORAL AND COMMON FEMORAL ARTERIES. THE BALLOON WAS SERIALLY INFLATED TO NOMINAL OR SUPRA NOMINAL PRESSURE AND HELD FOR 3 MINUTES. THE BALLOON WAS DEFLATED AND REMOVED. REPEAT ANGIOGRAM SHOWED DRAMATIC IMPROVEMENT WITH EXCELLENT FLOW DISTALLY WITH NO EVIDENCE OF ANY SIGNIFICANT DISSECTIONS AND DISTAL EMBOLIZATION. THE CATHETER AND SHEATH WERE REMOVED, A NON-BOSTON SCIENTIFIC CLOSE DEVICE WAS DEPLOYED AT THE PUNCTURE SITE WITH EXCELLENT HEMOSTASIS. THE PATIENT WAS TAKEN TO THE RECOVERY AREA IN STABLE CONDITION. ON (B)(6) 2024, PATIENT EXPERIENCED RECURRENT SYMPTOMS. ULTRASOUND STUDY SHOWED REOCCLUSION OF THE POPLITEAL ARTERY. SELEC

  Patient problems: Arteriosclerosis/ Atherosclerosis; Obstruction/Occlusion

  MAUDE report 19337210 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS AND ISCHEMIA OCCURRED. ON (B)(6) 2023, THE ENTIRE LENGTH OF THE SUPERFICIAL FEMORAL ARTERY TO THE MID-THIGH WAS TREATED WITH A ROTABLATOR ATHERECTOMY DEVICE. THIS WAS DONE WITHOUT COMPLICATION. PATIENT WAS IN A SUPINE POSITION UNDER LOCAL ANESTHESIA. A 5.0 X 200MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED AND PASSED TO COVER THE DISTAL RIGHT COMMON FEMORAL AND THE ENTIRE AFFECTED AREA OF THE SUPERFICIAL FEMORAL ARTERY. THE BALLOON WAS INFLATED WHERE THERE WAS A VERY SIGNIFICANT WAIST IN THE MORE DISTAL STENOSIS REQUIRING INCREASED PRESSURE UP TO 12 ATMOSPHERES, BUT ULTIMATELY COMPLETE EXPANSION WAS OBTAINED. INFLATION WAS HELD FOR 3 MINUTES, DEFLATED AND THEN REMOVED. REPEAT ANGIOGRAM SHOWED WIDE PATENCY TO THE SUPERFICIAL FEMORAL ARTERY END THROUGH THE PREVIOUSLY PLACED STENT WITH NO EVIDENCE OF A DISSECTION. RUNOFF FILMS SHOWED NO EVIDENCE OF ANY DISTAL EMBOLIZATION. DUE TO THE SIGNIFICANT SCARRING AND OBSTRUCTED DISEASE IN THE LEFT GROIN A CLOSURES DEVICE WAS NOT USED. THE PATIENT WAS TAKEN TO RECOVERY AREA IN STABLE CONDITION. ON (B)(6) 2024, RIGHT COMMON FEMORAL AND PROFUNDA FEMORAL ARTERIES HAD PATENCY. RIGHT SUPERFICIAL

  Patient problems: Ischemia; Restenosis

  MAUDE report 18916333 ↗
• MalfunctionJan 31, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 200MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON FIRST INFLATION AT 8 ATMOSPHERES FOR SEVERAL SECONDS THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18615696 ↗
• InjuryJan 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL TRIAL . IT WAS REPORTED THAT RESTENOSIS OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER PACLITAXEL-COATED PTA BALLOON CATHETER ON (B)(6) 2023 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA), RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY, RIGHT TIBIAL PERONEAL TRUNK AND RIGHT PERONEAL ARTERY WITH 6MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 200MM WITH 100% STENOSIS AND WAS CLASSIFIED AS TASC II C LESION. PRIOR TO THE TREATMENT OF TARGET LESION WITH THE STUDY DEVICE, PRE-DILATION WAS PERFORMED USING 5MM MUSTANG PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 5MM X 200MM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER STUDY DEVICE. FOLLOWING POST-TREATMENT WAS PERFORMED BY PLACEMENT OF 6MM X 200MM INNOVA BARE METAL STENT AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2023, THE SUBJECT WAS NOTED WITH SYMPTOMS RELATED TO IN-STENT RESTENOSIS IN THE RIGHT SFA. ON (B)(6) 2023, ARTERIOGRAM WAS PERFORMED WHICH REVEALED SEVERE IN-STENT RESTENOSIS IN RIGHT

  Patient problems: Restenosis

  MAUDE report 18586880 ↗
• MalfunctionJan 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 200MM, 150CM RANGER PACLITAXEL-COATED BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 6 ATMOSPHERES FOR 3 SECONDS, THE BALLOON RUPTURED IN A PINHOLE FORM NEAR THE DISTAL TIP. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586138 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT RESTENOSIS OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG-COATED BALLOONS ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, LEFT MID SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO LEFT DISTAL SUPERFICIAL FEMORAL ARTERY WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 380 MM WITH 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO THE TARGET LESION TREATMENT WITH THE STUDY DEVICE, ATHERECTOMY WAS PERFORMED USING A NON-BOSTON SCIENTIFIC (BSC) EXCHANGEABLE SYSTEM 1.50 SOLID ATHERECTOMY DEVICE AND PRE-DILATION WAS PERFORMED USING 4 MM X 300 MM NON-BSC 014 PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING TWO 5 MM X 200 MM RANGER DRUG-COATED BALLOONS STUDY DEVICES. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2023, 287 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS NOTED WITH SYMPTOMS RELATED TO STENOSIS IN THE LEFT SUPERFICIAL FEMORAL ARTE

  Patient problems: Hemoptysis; Ischemia; Muscle Weakness/Atrophy; Necrosis; Obstruction/Occlusion; Restenosis

  MAUDE report 18388472 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL TRIAL IT WAS REPORTED THAT RESTENOSIS OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG-COATED BALLOONS ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, LEFT MID SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO LEFT DISTAL SUPERFICIAL FEMORAL ARTERY WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 380 MM WITH 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO THE TARGET LESION TREATMENT WITH THE STUDY DEVICE, ATHERECTOMY WAS PERFORMED USING A NON-BOSTON SCIENTIFIC (BSC) EXCHANGEABLE SYSTEM 1.50 SOLID ATHERECTOMY DEVICE AND PRE-DILATION WAS PERFORMED USING 4 MM X 300 MM NON-BSC 014 PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING TWO 5 MM X 200 MM RANGER DRUG-COATED BALLOONS STUDY DEVICES. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2023, 287 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS NOTED WITH SYMPTOMS RELATED TO STENOSIS IN THE LEFT SUPERFICIAL FEMORAL ARTER

  Patient problems: Hemoptysis; Ischemia; Muscle Weakness/Atrophy; Necrosis; Obstruction/Occlusion; Restenosis

  MAUDE report 18381097 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS OCCURRED. ON (B)(6) 2023, THE PATIENT HAD A NON-HEALING WOUND TO THE LEFT FOOT TRANS-METATARSAL AMPUTATION SITE AND ANGIOGRAM REVEALED LEFT LEG REVASCULARIZATION (PREVIOUS INTERVENTION WAS UNKNOWN). THE AORTA AND BILATERAL COMMON, EXTERNAL, AND INTERNAL ILIAC ARTERIES WERE PATENT. THE LEFT COMMON FEMORAL, PROFUNDA FEMORIS, AND POPLITEAL ARTERIES WERE PATENT. THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WAS PATENT WITH SCATTERED AREAS OF SEVERE STENOSIS, AND SINGLE-VESSEL RUNOFF TO THE LEFT FOOT THROUGH THE PERONEAL ARTERY WITH AREAS OF SEVERE STENOSIS. THE CATHETER WAS ADVANCED TO THE LEFT SUPERFICIAL FEMORAL, POPLITEAL, AND PERONEAL ARTERIES WITH SELECTIVE ANGIOGRAPHY AT EACH LEVEL. A ROTABLATOR ATHERECTOMY DEVICE AND 5 MM RANGER DRUG-COATED BALLOON WAS USED FOR TREATMENT OF THE SFA. THE LEFT PERONEAL ARTERY WAS TREATED WITH A 2.5 MM PLAIN BALLOON. GOOD RESULT FROM REVASCULARIZATION OF THE LEFT SUPERFICIAL FEMORAL PERONEAL ARTERIES WITH SIGNIFICANTLY IMPROVED FLOW LUMEN AND MORE BRISK FILLING DOWN TO THE FOOT ON COMPLETION ANGIOGRAM. ON (B)(6) 2023, THE PATIENT RETURNED AGAIN WITH NON-HEALING WOUND TO THE LEFT FOOT TRANS-METATARSAL AMPUTATION SITE AND

  Patient problems: Restenosis

  MAUDE report 18360423 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ACUTE THROMBOSIS OCCURRED, REQUIRING INTERVENTION. A 5.0 X 200MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE IN AN ABDOMINAL AORTOGRAM, BILATERAL LOWER EXTREMITY ARTERIOGRAM, AND SELECTIVE LEFT LOWER EXTREMITY ARTERIOGRAM FROM THE COMMON FEMORAL ARTERY. A BOSTON SCIENTIFIC PATHWAYS ATHERECTOMY DEVICE WAS SELECTED AND ADVANCED THROUGH THE VESSEL TO TREAT THE OCCLUSION. ONCE ATHERECTOMY WAS COMPLETED, ANGIOGRAM SHOWED FLOW BUT THERE WAS SIGNIFICANT DEBRIS IN THE FILTER RESTRICTING FLOW, BUT NO HIGH-GRADE OBSTRUCTION WAS SEEN. THE RANGER BALLOON CATHETER WAS PASSED DOWN TO JUST ABOVE THE KNEE JOINT AND THE ENTIRE LENGTH OF THE POPLITEAL PROXIMALLY AND THE ENTIRE LENGTH OF THE SUPERFICIAL FEMORAL ARTERY WAS BALLOON DILATED SERIALLY WITH EACH INFLATION BEING TAKEN TO NOMINAL OR SUPRA NOMINAL PRESSURE WITH MULTIPLE WAISTS NOTED AND COMPLETE EXPANSION OBTAINED. EACH INFLATION WAS HELD FOR 3 MINUTES, DEFLATED, AND THEN REMOVED. FOLLOWING THE SERIAL DILATION, REPEAT ANGIOGRAM SHOWED A PATENT VESSEL THROUGH BUT SLOW FLOW DUE TO DEBRIS WITHIN THE FILTER. A BURN CATHETER WAS THEN ADVANCED FOR USE, AND REPEAT ANGIOGRAM SHOWED WIDELY PATENT SUPE

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18307184 ↗
• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL STUDY. IT WAS REPORTED THAT AN OCCLUSION OF THE STENT OCCURRED REQUIRING INTERVENTION. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON AND ELUVIA DRUG ELUTING STENT ON (B)(6) 2023 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY, RIGHT MID SUPERFICIAL FEMORAL ARTERY, RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY, RIGHT PROXIMAL POPLITEAL ARTERY EXTENDING UP TO RIGHT MID POPLITEAL ARTERY WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 440 MM WITH 90% STENOSIS AND WAS CLASSIFIED AS TASC II C LESION. PRIOR TO THE TARGET LESION TREATMENT WITH THE STUDY DEVICE, ATHERECTOMY WAS PERFORMED USING 1.5 MM NON-BOSTON SCIENTIFIC (BSC) ATHERECTOMY DEVICE AND PRE-DILATION WAS PERFORMED USING 5 MM X 200 MM NON-BSC PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICE, 5 MM X 200 MM RANGER DRUG-COATED BALLOON FOLLOWED BY PLACEMENT OF 6 MM X 100 MM ELUVIA DRUG ELUTING STENT. FOLLOWING POST-DILATION USING 5 MM X 200 MM NON-BSC PTA BALLOON, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 15%. ON (B)(6) 2023, THE SUBJECT WAS

  Patient problems: Obstruction/Occlusion; Vascular Dissection

  MAUDE report 18241780 ↗
• MalfunctionNov 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A RANGER PACLITAXEL-COATED PTA BALLOON CATHETER 5MM X 200MM, 150CM WAS SELECTED FOR ENDOVASCULAR THERAPY FOR LOWER EXTREMALITY ARTERIAL DISEASE OF THE SUPERFICIAL FEMORAL ARTERY. THE TARGET LESION HAD 100 PERCENT STENOSIS WITH MODERATE TORTUOSITY AND CALCIFICATION. THE PHYSICIAN INSERTED THE CATHETER, AND UPON TREATMENT THE BALLOON HAD A RUPTURED UPON A SINGLE INFLATION. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY USING ANOTHER RANGER WITHOUT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18238061 ↗