Ranger™ H74939419501510Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 08714729976028), received between Jun 9, 2021 and Aug 20, 2026 — classified as 18 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (12 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 34 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that target lesion revascularization occurred requiring additional intervention.The target lesions were located in the left common femoral artery, proximal superficial femoral artery, distal superficial femoral artery, and proximal popliteal artery. On (b)(6) 2025, a 6 x 150 mm, 150 cm Ranger Drug-Coated Balloon was used to treat target lesion #001, and a 5 x 150 mm, 150 cm Ranger Drug-Coated Balloon was used to treat target lesion #002. Both balloons were inflated once at 10 atmospheres for 180 seconds. On (b)(4) 2026, the patient underwent an interventional revascularization procedure consisting of Shockwave therapy, Rotarex atherectomy, and drug-coated balloon angioplasty and the event was considered resolved on (b)(6) 2026.

  Patient problems: Restenosis

  MAUDE report 50351076 ↗
• MalfunctionAug 17, 2026Material Rupture

  It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified superficial femoral artery. A 5.0 x 150mm, 150cm Ranger balloon catheter was advanced for dilation. During the first inflation at 6 atmospheres for 20 seconds, the balloon ruptured. 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 50278478 ↗
• InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL OCCLUSION OCCURRED REQUIRING INTERVENTION. ON (B)(6) 2021, AS PART OF THE CLINICAL TRIAL, THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON AND ELUVIA DRUG ELUTING STENTS. THE TARGET LESION #001 WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, MID SUPERFICIAL FEMORAL ARTERY, DISTAL SUPERFICIAL FEMORAL ARTERY AND PROXIMAL POPLITEAL ARTERY WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 4.5 MM DISTAL REFERENCE VESSEL DIAMETER WITH 360 MM LESION LENGTH AND 100% STENOSIS AND WAS CLASSIFIED AS TRANSATLANTIC INTER-SOCIETY CONSENSUS (TASC) II D LESION. PRIOR TO THE TREATMENT OF TARGET LESION WITH THE STUDY DEVICE, LITHOTRIPSY WAS PERFORMED USING 5 MM X 60 MM SHOCKWAVE DEVICE, PRE-DILATION WAS PERFORMED USING 4 MM X 220 MM, 3 MM X 220 MM COYOTE OTW PTA BALLOONS AND 3.5 MM X 120 MM SERRANATOR CUTTING BALLOON. THE TREATMENT OF STENOSIS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, MID SUPERFICIAL FEMORAL ARTERY, DISTAL SUPERFICIAL FEMORAL ARTERY AND PROXIMAL POPLITEAL ARTERY WAS PERFORMED BY DILATION USING 5 MM X 150 MM RANGER DRUG-COATED BALLOON, STUDY DEVICE. FOLLOWING WHICH 6 MM X 120 MM, 6 MM X 100 MM ELUVIA DRUG-ELUTING STENTS, STUDY

  Patient problems: Vascular Dissection

  MAUDE report 25818464 ↗
• MalfunctionMay 4, 2026Material Rupture

  It was reported that a balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery. A 5.0 x 150mm, 150cm Ranger drug coated balloon catheter was advanced for dilation. During the procedure, the balloon ruptured upon first inflation at 6 atmospheres for 20 seconds. The device was removed without any problem, and the procedure was completed with a different device. There were no patient complications as a result of this event.It was further reported that no rupture has occurred.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25065043 ↗
• MalfunctionApr 6, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 5.0 X 150MM, 150CM RANGER BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED AND KINKED. 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 24788521 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS OCCURRED. FOLLOWING THE INITIAL INTERVENTION PERFORMED ON (B)(6) 2025, THE PATIENT DEMONSTRATED IMPROVEMENT, HOWEVER, SIGNIFICANT RESIDUAL AND RECURRENT DISEASE PERSISTED IN THE TREATED VASCULAR SEGMENTS. DESPITE SUCCESSFUL RECANALIZATION AND DRUG-COATED BALLOON ANGIOPLASTY OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND PERONEAL ARTERY, SUBSEQUENT NONINVASIVE STUDIES AND CLINICAL ASSESSMENT PRIOR TO THE SECOND PROCEDURE ON (B)(6) 2025, REVEALED FLOW-LIMITING STENOSES IN THE RIGHT SFA, POPLITEAL ARTERY, AND RUNOFF VESSELS. DURING THE REPEAT ANGIOGRAPHIC EVALUATION, INTRAVASCULAR ULTRASOUND CONFIRMED MODERATE TO SEVERE DIFFUSE ATHEROSCLEROTIC DISEASE, INCLUDING INTERVAL PROGRESSION AND RESTENOSIS WITHIN PREVIOUSLY TREATED SEGMENTS. THESE FINDINGS NECESSITATED ADDITIONAL ENDOVASCULAR INTERVENTION INVOLVING ATHERECTOMY AND BALLOON ANGIOPLASTY ACROSS MULTIPLE VASCULAR LEVELS. COLLECTIVELY, THE RECURRENCE OF CLINICALLY SIGNIFICANT STENOSIS WITHIN A SHORT INTERVAL FOLLOWING THE PRIOR PROCEDURE IS CONSISTENT WITH RESTENOSIS.

  Patient problems: Obstruction/Occlusion; Restenosis

  MAUDE report 23620456 ↗
• InjuryOct 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS OCCURRED REQUIRING ADDITIONAL INTERVENTION. ON (B)(6) 2022, THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON AS A PART OF THE CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE RIGHT DISTAL POPLITEAL ARTERY AND RIGHT TIBIAL PERONEAL TRUNK WITH 4.5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 4 MM DISTAL REFERENCE VESSEL DIAMETER WITH 60 MM LESION LENGTH WITH 99 % STENOSIS AND WAS CLASSIFIED AS TASC II CLASS C LESION. PRIOR TO TREATMENT OF TARGET LESION WITH THE STUDY DEVICE, ATHERECTOMY WAS PERFORMED USING 1.5 MM NON-BOSTON SCIENTIFIC (BSC) ATHERECTOMY DEVICE, PRE-DILATION WAS PERFORMED USING 3 MM X 40 MM COYOTE PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 4 MM X 80 MM RANGER DRUG COATED BALLOON. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 30%. THE SECOND TARGET LESION WAS IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY AND RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY WITH 5.5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.5 MM DISTAL REFERENCE VESSEL DIAMETER WITH 120 MM LESION LENGTH WITH 70 % STENOSIS AND WAS CLASSIFIED AS TASC II CLASS B LESION. PRIOR TO TREATMENT OF TARGET LESION WITH THE STUDY

  Patient problems: Restenosis

  MAUDE report 23222229 ↗
• InjuryOct 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS OCCURRED REQUIRING ADDITIONAL INTERVENTION. ON (B)(6) 2022, THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS AS A PART OF A CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE RIGHT DISTAL POPLITEAL ARTERY AND RIGHT TIBIAL PERONEAL TRUNK WITH 4.5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 4 MM DISTAL REFERENCE VESSEL DIAMETER WITH 60 MM LESION LENGTH WITH 99 % STENOSIS AND WAS CLASSIFIED AS TASC II CLASS C LESION. PRIOR TO TREATMENT OF TARGET LESION WITH THE STUDY DEVICE, ATHERECTOMY WAS PERFORMED USING 1.5 MM NON-BOSTON SCIENTIFIC (BSC) ATHERECTOMY DEVICE AND PRE-DILATION WAS PERFORMED USING 3 MM X 40 MM COYOTE PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 4 MM X 80 MM RANGER DRUG COATED BALLOON STUDY DEVICE. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 30%. THE SECOND TARGET LESION WAS IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY AND RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY WITH 5.5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.5 MM DISTAL REFERENCE VESSEL DIAMETER WITH 120 MM LESION LENGTH WITH 70 % STENOSIS AND WAS CLASSIFIED AS TASC II CLASS B LESION. PRIOR TO TREATMENT OF TARGET LESION

  Patient problems: Restenosis

  MAUDE report 23221879 ↗
• MalfunctionSep 2, 2025Inflation Problem; Leak/Splash; Material Integrity Problem; Inflation Problem; Leak/Splash; Material Integrity Problem

  IT WAS REPORTED THAT A BALLOON LEAK OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. A 5.0 X 150MM, 150CM RANGER? DRUG-COATED BALLOON WAS SELECTED FOR USE IN AN ENDOVASCULAR THERAPY PROCEDURE. DURING THE FIRST INFLATION AT 4 ATMOSPHERES, THE BALLOON DID NOT INFLATE. THE DEVICE WAS REMOVED WITHOUT ISSUE, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. AN ATTEMPT WAS MADE TO INFLATE THE DEVICE OUTSIDE THE BODY AND A SOUND LIKE AIR ESCAPING FROM THE BALLOON WAS HEARD, BUT IT WAS NOT VISUALLY APPARENT. UPON INSPECTION, THERE APPEARED TO BE A FISSURE NEAR THE PROXIMAL PART THE BALLOON. IT IS POSSIBLE THAT THE BALLOON WAS DAMAGED AT SOME POINT. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22946830 ↗
• MalfunctionFeb 11, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT FOREIGN OBJECT WAS NOTED IN THE DEVICE'S PACKAGING. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 150MM, 150CM RANGER GLOBAL DCB BALLOON CATHETER WAS USED IN THE PROCEDURE. DURING PROCEDURE OUTSIDE PATIENT, A HUMAN HAIR WAS FOUND IN THE FINAL PACKAGING. THE DEVICE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21360218 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SLOW FLOW WAS OBSERVED, REQUIRING MEDICAL INTERVENTION. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY TO ANTERIOR TIBIAL ARTERY. AFTER PRE-DILATION WAS PERFORMED, CONTRAST OBSERVED NO SLOW FLOW. A 6.0 X 150MM, 150CM RANGER DRUG COATED BALLOON WAS USED; HOWEVER, THE BALLOON RUPTURED DURING FIRST DILATION AT 6 ATMOSPHERES. AT ALMOST THE SAME TIME, THE PATIENT MOVED THE OPERATED LEG SIGNIFICANTLY. THE ANGLE WAS APPROXIMATE, BUT THE HIP JOINT WAS ABDUCTED FOR ABOUT 30 DEGREES WHILE THE OPERATED KNEE WAS EXTENDED. A 5.0 X 150MM, 150CM AND 6.0 X 200MM, 150CM RANGER DRUG COATED BALLOONS WERE USED, BUT A SLOW FLOW WAS OBSERVED. A FINAL CONTRAST CONFIRMED THE SLOW FLOW. A NITROGLYCERIN WAS ADMINISTERED TO IMPROVE THE FLOW, AND THE PATIENT'S BLOOD PRESSURE TEMPORARILY DECREASED, BUT IT RETURNED WITHIN FEW MINUTES. THERE WAS NO EFFECT ON THE PATIENT'S OVERALL CONDITION AFTER THE PROCEDURE. ANOTHER CONTRAST PERFORMED AFTER 3 MINUTES SHOWED NO IMPROVEMENT, BUT IT WAS EVENTUALLY RESOLVED. THE POSSIBILITY OF DISTAL EMBOLIZATION WAS CONSIDERED THE CAUSE OF THE SLOW FLOW. IT WAS FURTHER REPORTED THAT

  Patient problems: Embolism/Embolus; Low Blood Pressure/ Hypotension; Reduced Blood Flow

  MAUDE report 21308807 ↗
• MalfunctionJun 18, 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 VESSEL. A 5.0 X 150MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED VERTICALLY. 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 19555693 ↗
• MalfunctionApr 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 150MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19147151 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL TRIAL . IT WAS REPORTED THERE WAS ISCHEMIA AND RESTENOSIS REQUIRING ADDITIONAL INTERVENTION. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG-COATED BALLOON ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO LEFT PROXIMAL POPLITEAL ARTERY WITH 5.0 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.0 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 120 MM WITH 90% STENOSIS AND WAS CLASSIFIED AS TASC II B LESION. PRIOR TO THE TARGET LESION TREATMENT WITH THE STUDY DEVICE, PRE-DILATION WAS PERFORMED BY USING 5.0 MM X 100 MM NON-BOSTON SCIENTIFIC PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICE, 5.0 MM X 150 MM RANGER DRUG-COATED BALLOON. POST TREATMENT OF TARGET LESION WAS PERFORMED BY PLACEMENT OF 5.0 MM X 120 MM AND 5.0 MM X 60 MM NON-BOSTON SCIENTIFIC BARE METAL STENT AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. DURING THE TREATMENT OF TARGET LESION, DISSECTION OF GRADE C WAS NOTED DUE TO 5.0 MM X 150 MM RANGER DRUG COATED BALLOON AND IN RESPONSE TO THE EVENT, BAILOUT STENT WAS IMPLANTED. ON THE SAME DAY, THE SUBJECT WAS DISCHARG

  Patient problems: Ischemia; Restenosis

  MAUDE report 18073635 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL TRIAL. IT WAS REPORTED AN OCCLUSION OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE SUBJECT UNDERWENT TREATMENT WITH RANGER DRUG COATED BALLOONS ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), MID SFA, DISTAL SFA, AND RIGHT DISTAL POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5 MM WITH LESION LENGTH OF 330 MM AND 100% STENOSIS AND TASC II D LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, ATHERECTOMY WAS PERFORMED USING A 2.2 MM X 1290 MM NON-BOSTON SCIENTIFIC ATHERECTOMY DEVICE. TREATMENT OF THE TARGET LESION WAS PERFORMED BY DILATATION USING STUDY DEVICES OF SIZES 5.0 MM X 200 MM AND 5.0 MM X 150 MM OF RANGER DRUG-COATED BALLOONS. FOLLOWING POST TREATMENT BY PLACEMENT OF 6 MM X 80 MM INNOVA BARE METAL STENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON (B)(6) 2022, THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2023, THE SUBJECT EXPERIENCED SUDDEN ONSET OF RIGHT FOOT PAIN, BILATERAL LOWER EXTREMITY COLDNESS AND DISCOLORATION WITH RIGHT LEG. ON (B)(6) 2023, THE SUBJECT VISITED

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 17967247 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT AN OCCLUSION OCCURRED. 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 #001 WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY, RIGHT MID SUPERFICIAL FEMORAL ARTERY, RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY AND RIGHT DISTAL POPLITEAL ARTERY WITH 5.0 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.0 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 330 MM AND 100% STENOSIS WAS CLASSIFIED AS TASC II D LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, ATHERECTOMY WAS PERFORMED WITH 2.2 MM X 1290 MM NON-BOSTON SCIENTIFIC ATHERECTOMY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING TWO 5 MM X 200 MM AND 5.0 MM X 150 MM RANGER DRUG COATED BALLOONS STUDY DEVICES. FOLLOWING POST TREATMENT BY PLACEMENT OF 6 MM X 80 MM INNOVA BARE METAL STENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON THE SAME DAY OF THE INDEX PROCEDURE, DURING TREATMENT OF THE TARGET LESION #001, DISSECTION OF GRADE C WAS NOTED DUE TO RANGER DRUG COATED BALLOONS. TWO RANGER DRUG COATED BALLOONS OF SIZES 5 MM X 200 MM AND 5.0 MM X 150 MM WERE

  Patient problems: Obstruction/Occlusion

  MAUDE report 17895597 ↗
• MalfunctionAug 9, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE AND GUIDEWIRE BECAME STUCK. A RANGER 5.0MM X 150MM, 150CM WAS SELECTED FOR USE FOR LOWER EXTREMITY RUNOFF FOR PERIPHERAL ARTERIAL DISEASE. THE RANGER BALLOON WAS ADVANCED AND INFLATED FOR 3 MINUTES TO COMPLETE TREATMENT; HOWEVER, UPON FULL DEFLATION THERE WAS DIFFICULTY REMOVING THE BALLOON OFF THE WIRE. THE CATHETER GOT STUCK ON THE WIRE AND REQUIRED THEM TO BE WITHDRAWN TOGETHER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SEQUELAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17487862 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE STUDY: IT WAS REPORTED THAT VESSEL OCCLUSION WAS OBSERVED, AND ADDITIONAL DEVICES WERE REQUIRED. THE SUBJECT UNDERWENT TREATMENT WITH RANGER DRUG COATED BALLOONS ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT PROXIMAL SFA, MID SFA, DISTAL SFA, EXTENDING UP TO PROXIMAL POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5 MM WITH LESION LENGTH OF 330 MM AND 100% STENOSIS AND TASC II D LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, ATHERECTOMY WAS PERFORMED USING 2.2 MM X 1290 MM NON-BOSTON SCIENTIFIC (BSC) ATHERECTOMY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATATION USING STUDY DEVICES OF SIZES 5 MM X 200 MM AND 5 MM X 150 MM OF RANGER DRUG-COATED BALLOONS. FOLLOWING POST TREATMENT BY PLACEMENT OF 6 MM X 80 MM INNOVA BARE METAL STENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON (B)(6) 2022, SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. PER EDC, ON (B)(6) 2023, SUBJECT WAS NOTED WITH SYMPTOMS RELATED TO OCCLUSION IN RIGHT SFA AND POPLITEAL ARTERY. OF NOTE, PER SOURCE, ON (B)(6) 2022, RIGHT LOWER EXTREMITY ARTERIAL DUPLEX REVEALED OCCLUDE

  Patient problems: Hematoma; Ischemia; Obstruction/Occlusion

  MAUDE report 17227702 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT THROMBOSIS AND AN AMPUTATION OCCURRED. 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 #001 WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY, RIGHT MID SUPERFICIAL FEMORAL ARTERY, RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO RIGHT PROXIMAL POPLITEAL ARTERY WITH 5.0 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.0 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 330 MM AND 100% STENOSIS WAS CLASSIFIED AS TASC II D LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, ATHERECTOMY WAS PERFORMED WITH 2.2 MM X 1290 MM NON-BOSTON SCIENTIFIC ATHERECTOMY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING TWO 5 MM X 200 MM AND 5.0 MM X 150 MM RANGER DRUG COATED BALLOONS STUDY DEVICES. FOLLOWING POST TREATMENT BY PLACEMENT OF 6 MM X 80 MM INNOVA BARE METAL STENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON THE SAME DAY OF THE INDEX PROCEDURE, DURING TREATMENT OF THE TARGET LESION #001, DISSECTION OF GRADE C WAS NOTED DUE TO RANGER DRUG COATED BALLOONS. DURING THE INDEX PROCEDURE, TWO RANGER DRUG COATED

  Patient problems: Ischemia; Thrombosis/Thrombus

  MAUDE report 17199107 ↗
• MalfunctionJun 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PINHOLE RUPTURE OCCURRED. A 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER 5.0 X 150MM WAS SELECTED FOR THE INDEX PROCEDURE. DURING THE FIRST INFLATION AT 4 ATMOSPHERES FOR 5 SECONDS INFLATION TIME, THERE WAS A PINHOLE RUPTURE AT THE MIDDLE PART OF THE BALLOON. THE DEVICE WAS REMOVED NORMALLY AND REPLACED WITH ANOTHER RANGER BALLOON TO COMPLETE THE PROCEDURE. 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 17079045 ↗
• MalfunctionJan 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURED OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THE 5.0 X 150MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS ADVANCED. DURING THE FIRST INFLATION AFTER APPROXIMATELY 1 MINUTE, THE MIDDLE PART OF THE BALLOON RUPTURED AT 12 ATM, IN THE FORM OF A PINHOLE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16194016 ↗
• MalfunctionSep 23, 2022Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE BALLOON HAD A HOLE. A RANGER PACLITAXEL-COATED PTA 5.0MM X 150MM, 150CM BALLOON CATHETER WAS SELECTED FOR USE TO TREAT THE SUPERFICIAL FEMORAL ARTERY STENOSIS. THE PHYSICIAN INSERTED THE CATHETER, AND UPON TREATMENT OF THE AREA THE BALLOON NEVER INFLATED. THE CATHETER WAS REMOVED AND A HOLE WAS OBSERVED. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY USING ANOTHER RANGER DEVICE WITHOUT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15470276 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL STUDY. IT WAS REPORTED THAT A DISSECTION OCCURRED. THE SUBJECT WAS ENROLLED IN THE ELEGANCE CLINICAL STUDY AND THE INDEX PROCEDURE WAS PERFORMED ON (B)(6) 2022. THE TARGET LESION WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), RIGHT MID SUPERFICIAL FEMORAL ARTERY EXTENDING INTO RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY WITH 80% STENOSIS. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, PRE-DILATION WAS PERFORMED WITH 5 MM X 40 MM STERLING OTW PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY STUDY DEVICE, 5 MM X 150 MM RANGER DRUG COATED BALLOON. FOLLOWING POST DILATION WITH STUDY DEVICE, 5.5 MM X 40 MM SUPRA BARE METAL STENT WAS IMPLANTED WHICH WAS POST DILATED WITH 5 MM X 40 MM STERLING PTA BALLOON. THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON (B)(6) 2022, THE SAME DAY OF INDEX PROCEDURE, SUBJECT WAS NOTED WITH SEVERE LIFESTYLE LIMITING CLAUDICATION UNRESPONSIVE TO MEDICAL THERAPY UNDERWENT INTERVENTIONAL PROCEDURE. 100% OCCLUSION NOTED IN RIGHT MID SFA, AND 80% STENOSIS NOTED IN RIGHT DISTAL SFA WAS SUCCESSFULLY ACCESSED WHICH WERE PREDILATED WITH 5 MM X 40 MM STERLING OTW PTA BALLOON. SUBSEQUENTLY, 5 MM X 150 MM RANGER DRUG COATED BAL

  Patient problems: Vascular Dissection

  MAUDE report 15423414 ↗
• MalfunctionAug 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 150MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR THE PERCUTANEOUS ANGIOPLASTY PROCEDURE. DURING THE FIRST INFLATION, AT 8 ATMOSPHERES FOR 10 SECONDS DURATION TIME, THE BALLOON RUPTURED IN A PINHOLE SHAPE AT THE DISTAL TIP. AFTER DECOMPRESSION, THE DEVICE WAS REMOVED FROM THE BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15189384 ↗
• MalfunctionJul 19, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 5.0 X 150MM, 150CM RANGER DRUG COATED BALLOON WAS SELECTED FOR TREATMENT OF PERIPHERAL ARTERIAL DISEASE IN THE SUPERFICIAL FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTIOUS AND MODERATELY CALCIFIED ANATOMY WITH 90% STENOSIS. DURING THE PROCEDURE, THE BALLOON RUPTURED WHEN IT WAS INFLATED ONCE TO 10 ATMOSPHERES FOR 20 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS USING THE NORMAL METHOD. 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 15057742 ↗