Ranger™ H74939419601510Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 08714729976189), received between Oct 12, 2021 and Sep 30, 2026 — classified as 10 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (15 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 27 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Vascular Dissection

  MAUDE report 50948177 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that gangrene of the right 5th toe occurred with occlusion of the right SFA treatment site, requiring additional intervention.The subject underwent treatment with the Ranger drug-coated balloon on (b)(6) 2026 as a part of the clinical trial. The target lesion #001 was in the right proximal superficial femoral artery (SFA) with 6 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with 10 mm lesion length and 80 % stenosis and classified as TransAtlantic InterSociety Consensus (TASC) II B lesion. Prior to the treatment of target lesion with the study device, atherectomy was performed with 1.5 mm x 145 mm diamondback atherectomy device and pre-dilation was performed using 5 mm x 220 mm Sterling balloon. Treatment of target lesion was performed by dilation using 6 mm x 200 mm Ranger drug coated balloon, study device. The balloon was inflated once to a maximum inflation pressure of 8 atmospheres for 3 seconds. Following treatment, the final residual stenosis was noted to be 35%. The target lesion #002 was in the right distal superficial femoral artery with 6 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with

  Patient problems: Necrosis; Obstruction/Occlusion

  MAUDE report 50779600 ↗
• InjuryJul 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TARGET LESION REVASCULARIZATION (TLR) OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MID SUPERFICIAL FEMORAL ARTERY OF THE RIGHT LEG. ON (B)(6) 2025, A 6.0 X 150 MM, 150 CM RANGER DRUG-COATED BALLOON WAS SELECTED FOR USE IN A CLINICAL STUDY. THE BALLOON WAS INFLATED ONCE AT 14 ATMOSPHERES FOR 180 SECONDS. ON (B)(6) 2026, THE PATIENT UNDERWENT TARGET LESION REVASCULARIZATION USING A DRUG-COATED BALLOON. THEN IT RESULTED IN A NEW HOSPITALIZATION ON THE SAME DAY. ON JUN. 2, 2026, THE EVENT WAS CONSIDERED RESOLVED.

  Patient problems: Restenosis

  MAUDE report 25725387 ↗
• MalfunctionApr 2, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE PROCEDURE WAS PERFORMED TO TREAT A 100% STENOSED TARGET LESION LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0 X 150 MM, 150 CM RANGER DRUG-COATED BALLOON WAS ADVANCED FOR DILATATION. FOLLOWING PRE-DILATATION, A 6 MM SHIDEN HP BALLOON WAS ALSO USED. DURING THE FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING 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 24772015 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL OCCLUSION AND RESTENOSIS OCCURRED REQUIRING ADDITIONAL INTERVENTION AND MEDICATION. ON (B)(6) 2025, THE PATIENT PRESENTED WITH PERIPHERAL VASCULAR DISEASE WITH TOTAL OCCLUSION OF THE LEFT SUPERFICIAL FEMORAL AND POPLITEAL ARTERIES AND REST PAIN. THE ENTIRE LENGTH OF THE SUPERFICIAL FEMORAL AND POPLITEAL ARTERIES WAS TREATED IN THREE SECTIONS, WITH TWO CAREFUL PASSES PERFORMED THROUGH EACH SECTION USING A NON-BOSTON SCIENTIFIC ATHERECTOMY DEVICE. PATIENT WAS IN A SUPINE POSITION UNDER LOCAL INFILTRATIVE ANESTHESIA. A 21-GAUGE MICROPUNCTURE NEEDLE WAS USED AND A 0.018 WIRE PASSED FOLLOWED BY 4 FRENCH INTRODUCER, A 0.035 GLIDEWIRE WAS PASSED TO THE SUPRARENAL AORTA, AND A 5 FRENCH SHEATH WAS PLACED. AN OMNI FLUSH CATHETER WAS PASSED TO THE LEVEL OF L1 AND AN ABDOMINAL AORTOGRAM WAS PERFORMED. A 6 X 150 DRUG-COATED RANGER BALLOON WAS SELECTED. THE ENTIRE LENGTH OF THE BELOW-KNEE POPLITEAL, ABOVE-KNEE POPLITEAL, SUPERFICIAL FEMORAL ARTERY UP TO THE COMMON FEMORAL ARTERY WAS SERIALLY DILATED. REPEAT ANGIOGRAM SHOWED WIDE PATENCY OF THE ANTERIOR TIBLAL ARTERY. ATTENTION WAS THEN TURNED TO THE TIBIOPERONEAL TRUNK AND POSTERIOR TIBIAL ARTERY. THE V18 WIRE WAS RED

  Patient problems: Obstruction/Occlusion; Restenosis

  MAUDE report 23610220 ↗
• MalfunctionSep 8, 2025Material 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 6.0 X 150MM, 150CM RANGER BALLOON CATHETER WAS SELECTED FOR USE IN AN ENDOVASCULAR THROMBECTOMY. DURING THE FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED FROM A PINHOLE NEAR THE CENTER. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE 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 22994985 ↗
• MalfunctionAug 18, 2025Material 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 6.0 X 150MM, 150CM RANGER? DRUG COATED BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED 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 22824905 ↗
• MalfunctionJun 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST DURING INFLATION. A OTW 6.0 X 150MM,150CM RANGER (DCB) DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN INFLATING THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR 20 SECONDS. THERE WERE NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22237426 ↗
• MalfunctionFeb 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0 X 150 MM, 150 CM RANGER BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 8 ATMOSPHERES FOR 60 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE 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 21334878 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS ON (B)(6) 2023 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO RIGHT PROXIMAL POPLITEAL ARTERY WITH 6 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 200 MM WITH 100% STENOSIS AND WAS CLASSIFIED AS TASC II C LESION. PRIOR TO THE TARGET LESION TREATMENT WITH THE STUDY DEVICE, PRE-DILATION WAS PERFORMED USING 5 MM X 100 MM STERLING OVER THE WIRE BALLOON PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICE, 6 MM X 150 MM RANGER DRUG-COATED BALLOON. FOLLOWING POST-TREATMENT WAS PERFORMED BY PLACEMENT OF 6 MM X 150 MM NON-BOSTON SCIENTIFIC (BSC) PERIPHERAL STENT SYSTEM BARE METAL STENT AND, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 29%. THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY TO MID POPLITEAL ARTERY WERE TREATED BY 6 MM X 150 MM RANGER DCB (STUDY DEVICE). HENCE, IT WAS CONFIRMED THAT THE TARGET LESIONS WERE TREATED BY STUDY DEVICE (RANGER DCB 6 MM X 150 MM). THE TARGET LESIO

  Patient problems: Vascular Dissection

  MAUDE report 20412230 ↗
• MalfunctionMay 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY STENOSIS. A 6.0 X 150MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, ON THE FIRST INFLATION AT 10 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE RUPTURE WAS OBSERVED TO BE IN A VERTICAL SHAPE. A DIFFERENT 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 19274344 ↗
• MalfunctionFeb 15, 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 LEFT SUPERFICIAL FEMORAL ARTERY. A 6.0 X 150MM, 150CM RANGER DRUG COATING BALLOON WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION, THE BALLOON WAS RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 18715489 ↗
• InjuryJan 19, 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 DRUG COATED BALLOON ON (B)(6) 2023 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO RIGHT MID SUPERFICIAL FEMORAL ARTERY WITH 6.0 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6.0 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 150 MM WITH 90% STENOSIS AND WAS CLASSIFIED AS TASC II B LESION. PRIOR TO THE TARGET LESION TREATMENT WITH THE STUDY DEVICE, ATHERECTOMY WAS PERFORMED BY USING 4.0 MM X 120 MM NON-BOSTON SCIENTIFIC (BSC) ATHERECTOMY DEVICE AND PRE-DILATION WAS PERFORMED BY USING 5.0 MM X 100 MM STERLING PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICE, 6.0 MM X 150 MM RANGER DRUG-COATED BALLOON. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 5%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2023, SUBJECT WAS NOTED WITH WORSENING SYMPTOMS RELATED TO PERIPHERAL ARTERY DISEASE IN THE RIGHT LEG. ON (B)(6) 2023, 120 DAYS POST INDEX PROCEDURE, 70% STENOSIS NOTED IN THE RIGHT PROXIMAL SUPERFICIAL FE

  Patient problems: Restenosis

  MAUDE report 18545080 ↗
• MalfunctionJan 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LOCATION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0 X 150MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 6 ATMOSPHERES FOR ONE SECOND, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 18478689 ↗
• InjuryOct 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DISSECTION OCCURRED, REQUIRING AN ADDITIONAL STENT. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG-COATED BALLOONS ON (B)(6) 2023 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, LEFT MID SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO LEFT DISTAL SUPERFICIAL FEMORAL ARTERY WITH 6 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 250 MM WITH 100% STENOSIS. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, ATHERECTOMY WAS PERFORMED BY USING A NON-BOSTON SCIENTIFIC (BSC) ATHERECTOMY DEVICE AND PRE-DILATION WAS PERFORMED BY USING 4.0 MM X 240 MM NON-BSC BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 5 MM X 200 MM, 6 MM X 200 MM, AND 6 MM X 150 MM RANGER DRUG-COATED BALLOONS STUDY DEVICES. FOLLOWING POST TREATMENT, DILATION WAS PERFORMED BY USING 5 MM X 120 MM NON-BSC BALLOONS, PLACEMENT OF 6.0 MM X 150 MM INNOVA BARE METAL STENT AND 6.0 MM X 125 MM NON-BSC BARE METAL STENT. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. THE SECOND TARGET LESION WAS IN THE LEFT PROXIMAL POPLITEAL ARTERY, LEFT MID POPL

  Patient problems: Vascular Dissection

  MAUDE report 17931548 ↗
• MalfunctionAug 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE IN THE ENDOVASCULAR THERAPY PROCEDURE TO TREAT THE PATIENT CONDITION OF PERIPHERAL ARTERY DISEASE. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. THE RANGER WAS ADVANCED TO THE TARGET LESION AND INFLATED TO 12 ATM AN UNSPECIFIED NUMBER OF TIMES BEFORE THE BALLOON RUPTURED. THE RANGER DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ISSUE AND REPLACED WITH ANOTHER RANGER DEVICE IN ORDER TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT INJURIES, AND THE PATIENT CONDITION WAS GOOD FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17461552 ↗
• MalfunctionJul 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 6.0 X 150MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE. DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ANY ISSUES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17280053 ↗
• MalfunctionJul 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 6.0 X 150MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE. DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ANY ISSUES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17269847 ↗
• MalfunctionJun 29, 2023Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST AND WAS LEAKING. A 6.0 X 150MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. THE VERY CALCIFIED LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. THE BALLOON DEVELOPED A LEAK AND BURST DURING THE FIRST INFLATION AT 6 ATM FOR 30 SECONDS, AND NEVER REACHED FULL SIZE. THE BALLOON WAS REMOVED INTACT, AND A SECOND BALLOON OF THE SAME SIZE WAS THEN ADVANCED TO THE LESION AND INFLATED. SHORTLY AFTER INFLATION, THE BALLOON BEGAN LOSING PRESSURE AND WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RANGER BALLOON. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17225425 ↗
• MalfunctionJun 29, 2023Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST AND WAS LEAKING. A 6.0 X 150MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. THE VERY CALCIFIED LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. THE BALLOON DEVELOPED A LEAK AND BURST DURING THE FIRST INFLATION AT 6 ATM FOR 30 SECONDS, AND NEVER REACHED FULL SIZE. THE BALLOON WAS REMOVED INTACT, AND A SECOND BALLOON OF THE SAME SIZE WAS THEN ADVANCED TO THE LESION AND INFLATED. SHORTLY AFTER INFLATION, THE BALLOON BEGAN LOSING PRESSURE AND WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RANGER BALLOON. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17225386 ↗
• MalfunctionMar 16, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE AND GUIDEWIRE BECAME STUCK. A RANGER 6.0MM X 150MM, 150CM WAS SELECTED FOR USE IN THIS ATHERECTOMY PROCEDURE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A CORDES WIRE WAS PLACED ACROSS THE LESION AND THE RANGER BALLOON WAS ADVANCED. THE BALLOON WAS INFLATED TO 6 ATM FOR 3 MINUTES; HOWEVER, WHILE REMOVING THE BALLOON GOT STUCK INTO THE WIRE. THE BALLOON AND THE WIRE WERE REMOVED TOGETHER, AND ANOTHER BALLOON THE SAME SIZE WAS USED TO FINISH THE PROCEDURE. NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16554779 ↗
• InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL STUDY: IT WAS REPORTED THAT RESTENOSIS OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON AND ELUVIA DRUG ELUTING STENT ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), LEFT MID SFA EXTENDING TO LEFT DISTAL SFA WITH 6.5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 300 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, BALLOON ANGIOPLASTY WAS PERFORMED WITH 5.0 MM X 200 MM AND 6.0 MM X 220 MM STERLING PTA BALLOONS. THE TREATMENT OF TARGET LESION WAS PERFORMED BY DILATATION WITH STUDY DEVICE, RANGER DRUG COATED BALLOON OF 6.0 MM X 200 MM AND 6 MM X 150 MM AND PLACEMENT OF 7 MM X 120 MM ELUVIA DRUG ELUTING STENT. FOLLOWING POST DILATATION WITH 6.0 MM X 100 MM STERLING PTA BALLOON, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 9%. ON (B)(6) 2022, ON THE SAME DAY OF INDEX PROCEDURE, DURING THE TREATMENT OF TARGET LESION #001, DISSECTION OF GRADE C WAS NOTED IN THE TARGET LESION DUE TO RANGER DRUG COATED BALLOON OF 6.0 MM X 150 MM. IN RESPO

  Patient problems: Obstruction/Occlusion; Restenosis; Vascular Dissection

  MAUDE report 15700930 ↗
• MalfunctionJun 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 6.0MM X 150MM, 150CM RANGER DRUG COATED BALLOON WAS SELECTED TO TREAT PERIPHERAL ARTERY DISEASE IN THE SUPERFICIAL FEMORAL ARTERY. THE TARGET LESION WAS 75% STENOSED, HAD MODERATE CALCIFICATION AND MODERATE TORTUOSITY. DURING THE PROCEDURE, THE BALLOON WAS INFLATED TO 14 ATMOSPHERES FOR 1 SECOND. DURING THIS INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS USING THE NORMAL METHOD. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14632947 ↗
• InjuryMay 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) STUDY: IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON AND ELUVIA DRUG ELUTING STENT ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT PROXIMAL SFA, LEFT MID SFA EXTENDING TO LEFT DISTAL SFA WITH 6.5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 300 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO TARGET LESION TREATMENT, PTA BALLOON WAS PERFORMED WITH STERLING 5.0 MM X 200 MM AND STERLING 6.0 MM X 220 MM PTA BALLOON. THE TREATMENT OF TARGET LESION WAS PERFORMED BY DILATATION WITH STUDY DEVICE, RANGER DRUG COATED BALLOON OF 6.0 MM X 200 MM AND 6 MM X 150 MM FOLLOWED BY PLACEMENT OF STUDY DEVICE, ELUVIA DRUG ELUTING STENT 7 MM X 120 MM. FOLLOWING POST DILATATION WAS PERFORMED WITH 6.0 MM X 100 MM STERLING PTA BALLOON AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 9%. ON (B)(6) 2022, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2022, ON THE SAME DAY OF INDEX PROCEDURE, AFTER TREATMENT OF THE TARGET LESION, DISSECTION OF GRADE C WAS NOTED IN THE TARGET LESION. SITE CONFIRMED THE DIS

  Patient problems: Vascular Dissection

  MAUDE report 14366049 ↗
• MalfunctionApr 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PINHOLE BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A 100% STENOSED, MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0 X 150MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR THE ENDOVASCULAR THERAPY PROCEDURE. DURING THE FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. AFTER DECOMPRESSION, THE DEVICE WAS REMOVED FROM THE BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14001913 ↗