Ranger™ H74939419602010Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 08714729976202), received between Apr 27, 2021 and Sep 29, 2026 — classified as 47 injuries, 24 malfunctions.

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

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Vascular Dissection

  MAUDE report 50940541 ↗
• 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 50779598 ↗
• MalfunctionMar 17, 2026Material Rupture

  T WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY. A 6.0 X 200MM, 150CM RANGER (DCB) BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION. 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 24621454 ↗
• MalfunctionFeb 20, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY. A 6.0 X 200MM, 150CM RANGER GLOBAL DCB BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 4 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 24407037 ↗
• MalfunctionFeb 12, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. A 6.0 X 200MM, 150CM RANGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INITIAL INFLATION AT 6 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED VERTICALLY AT THE DISTAL PART. THE DEVICE WAS REMOVED, 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 24322494 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION OF COMMON FEMORAL ARTERY TO POPLITEAL ARTERY BYPASS OCCURRED. ON (B)(6) 2024, TWO 6.0 X 150MM, 150CM RANGER WERE SELECTED FOR USE AS PART OF THE CLINICAL STUDY. ON (B)(6) 2025, IT WAS NOTED THAT A REVISION OF COMMON FEMORAL ARTERY TO POPLITEAL ARTERY BYPASS OCCURRED WHICH RESULTED IN PROLONGED HOSPITALIZATION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2025. IT WAS FURTHER REPORTED THAT RIGHT SUPERFICIAL FEMORAL ARTERY OCCLUSIVE DISEASE WITH REST PAIN OCCURRED.

  Patient problems: Pain; Restenosis

  MAUDE report 23844155 ↗
• MalfunctionNov 12, 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 200MM, 150CM RANGER DRUG COATED BALLOON WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 3 SECONDS, THE BALLOON RUPTURED FROM A PINHOLE LOCATED AT THE TIP. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23531904 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DISSECTION WAS NOTED REQUIRING INTERVENTION. ON (B)(6) 2025, THE SUBJECT UNDERWENT TREATMENT WITH THE ELUVIA DRUG-ELUTING STENT AND RANGER DRUG COATED BALLOONS AS A PART OF THE CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY AND LEFT MID SUPERFICIAL FEMORAL ARTERY WITH 6 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6 MM DISTAL REFERENCE VESSEL DIAMETER WITH 100 MM LESION LENGTH WITH 80% STENOSIS AND WAS CLASSIFIED AS TASC II B LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, ATHERECTOMY WAS PERFORMED USING 2.2 MM X 3000 MM PHOENIX ATHERECTOMY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 6 MM X 200 MM RANGER DRUG-COATED BALLOON AND PLACEMENT OF 7 MM X 40 MM ELUVIA DRUG ELUTING STENT STUDY DEVICES. FOLLOWING TREATMENT WAS PERFORMED BY PLACEMENT OF 5.5 MM X 150 MM SUPERA BARE METAL STENT AND BALLOON DILATION USING 5.5 MM X 20 MM ARMADA PTA BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. THE TARGET LESION #002 WAS IN THE LEFT DISTAL POPLITEAL ARTERY WITH 4 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 4 MM DISTAL REFERENCE VESSEL DIAMETER WITH 10 MM LESION LENGTH WITH 80%

  Patient problems: Vascular Dissection

  MAUDE report 23477696 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS AND PAIN OCCURRED. ON (B)(6) 2024, THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS AS A PART OF A CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), RIGHT MID SUPERFICIAL FEMORAL ARTERY, RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO RIGHT PROXIMAL POPLITEAL ARTERY WITH 6 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 390 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICES, 6 MM X 200 MM AND 4 MM X 200 MM RANGER DRUG COATED BALLOONS. FOLLOWING TREATMENT, 6 MM NON-BOSTON SCIENTIFIC (BSC) STENT WAS PLACED FROM RIGHT PROXIMAL SFA EXTENDING TO PROXIMAL POPLITEAL ARTERY FOLLOWED BY BALLOON TAILORING YIELDING COMPLETION AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 40%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM HOSPITAL ON CLOPIDOGREL. ON (B)(6) 2025, SUBJECT VISITED THE EMERGENCY DEPARTMENT WITH THE COMPLAINTS OF WORSENED RIGHT LEG CLAUDICATION WITH SHORT WALKING DISTANCE AND OCCASIONAL REST PAIN. OF NOTE, ON OUTPATIENT DUPLEX OF RIGHT

  Patient problems: Arteriosclerosis/ Atherosclerosis; Pain; Restenosis

  MAUDE report 23351690 ↗
• InjurySep 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS AND OCCLUDED VESSEL 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 #001 WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 5.8 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.8 MM DISTAL REFERENCE VESSEL DIAMETER WITH 20 MM LESION LENGTH WITH 90% STENOSIS AND WAS CLASSIFIED AS TASC II CLASS B LESION. PRIOR TO THE TREATMENT OF TARGET LESION WITH STUDY DEVICE, PRE-DILATION WAS PERFORMED BY USING 6 MM X 200 MM NON-BOSTON SCIENTIFIC (BSC) PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 6 MM X 200 MM RANGER DRUG COATED BALLOON STUDY DEVICE. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%. THE TARGET LESION #002 WAS IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY, RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO RIGHT PROXIMAL POPLITEAL ARTERY WITH 5.5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.5 MM DISTAL REFERENCE VESSEL DIAMETER WITH 120 MM LESION LENGTH WITH 60% STENOSIS AND WAS CLASSIFIED AS TASC II CLASS B LESION. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 6 MM X

  Patient problems: Obstruction/Occlusion; Pain; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 23168107 ↗
• MalfunctionJun 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. A 6.0 X 200MM, 150CM RANGER BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 6 ATMOSPHERES FOR 1 MINUTE, THE BALLOON RUPTURED IN A PINHOLE FORM AT THE MIDDLE PART. 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 22210832 ↗
• MalfunctionMay 21, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PACKAGING ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE PERIPHERAL ARTERY. A 6.0 X 200MM, 150CM RANGER BALLOON CATHETER WAS SELECTED FOR USE. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE OUTER BOX AND INNER PACKAGE DID NOT CORRESPOND WITH EACH OTHER. THE OUTER SHIPPING CONTAINER WAS INTACT WITH NO EVIDENCE OF PRIOR OPENING OR DAMAGE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22066119 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A THROMBOTIC OCCLUSION. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON ON (B)(6) 2023. THE TARGET LESION #001 WAS IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY, LEFT DISTAL SUPERFICIAL FEMORAL ARTERY, LEFT PROXIMAL POPLITEAL ARTERY EXTENDING UP TO LEFT MID POPLITEAL ARTERY WITH 6.8 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6.4 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 200 MM AND 90% STENOSIS AND WAS CLASSIFIED AS TASC II B LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, NON-BOSTON SCIENTIFIC (BSC) EMBOLIC PROTECTION DEVICE WAS PLACED, ATHERECTOMY WAS PERFORMED BY USING NON-BSC ATHERECTOMY DEVICE AND PRE-DILATION WAS PERFORMED BY USING 7.0 MM X 150 MM STERLING PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 6 MM X 200 MM RANGER DRUG-COATED BALLOON STUDY DEVICE. POST TARGET LESION TREATMENT WAS PERFORMED BY PLACEMENT OF 6.5 MM X 150 MM SUPERA STENT AND DILATION USING 3.0 MM X 60 MM COYOTE PTA BALLOON. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 30%. ON (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM HOSPITAL ON CLOPIDOGREL. ON (B)(6) 2024, THE SUBJECT E

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

  MAUDE report 22035191 ↗
• MalfunctionMay 1, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY, PELVIC ORGAN. A 6.0 X 200MM, 150CM RANGER DRUG-COATED BALLOON CATHETER WAS ADVANCED FOR ENDOVASCULAR THERAPY PROCEDURE. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON INITIAL INFLATION AT 6 ATMOSPHERES FOR 5 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21940828 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A CLINICAL STUDY THAT VESSEL OCCLUSION OCCURRED, REQUIRING INTERVENTION. ON (B)(6) 2024, A RIGHT LOWER EXTREMITY ANGIOGRAM REVEALED OCCLUSION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) IN THE REGION OF A PROXIMAL STENT, AND DISEASE OF THE SFA DISTALLY, WITH GOOD RECANNULATION IN THE DISTAL SFA AND EXCELLENT 3 VESSEL RUN-OFF TO THE FOOT. AN OCCLUSION WAS NOTED IN RIGHT PROXIMAL SFA, RIGHT MID SFA, RIGHT DISTAL SFA, AND RIGHT POPLITEAL ARTERY, WHICH WERE TREATED BY BALLOON ANGIOPLASTY USING THESE TWO 6 X 200 MM RANGER DRUG COATED BALLOONS. THIS WAS FOLLOWED BY PLACEMENT OF A 6 MM X 50 MM NON-BOSTON SCIENTIFIC ENDOPROSTHESIS STENT IN THE RIGHT PROXIMAL SFA, AND WAS POST DILATED USING A 6 MM X 40 MM RANGER DRUG COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 30%. THE EVENT WAS CONSIDERED TO BE RESOLVED AND ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2024, THE SUBJECT PRESENTED TO THE HOSPITAL WITH THE COMPLAINT OF RIGHT THIGH PAIN FOR THE PREVIOUS WEEK, INDICATIVE OF A NEW OCCLUDED STENT OR INJURY TO THE PROFUNDA. ON THE SAME DAY, RIGHT LOWER EXTREMITY ANGIOGRAM REVEALED A WIDELY PATENT PROXIMAL SFA STENT AND PRO

  Patient problems: Arteriosclerosis/ Atherosclerosis; Obstruction/Occlusion

  MAUDE report 21768986 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A CLINICAL STUDY THAT VESSEL OCCLUSION OCCURRED REQUIRING INTERVENTION. ON (B)(6) 2024, A RIGHT LOWER EXTREMITY ANGIOGRAM REVEALED OCCLUSION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) IN THE REGION OF A PROXIMAL STENT, AND DISEASE OF THE SFA DISTALLY, WITH GOOD RECANNULATION IN THE DISTAL SFA AND EXCELLENT 3 VESSEL RUN-OFF TO THE FOOT. AN OCCLUSION WAS NOTED IN RIGHT PROXIMAL SFA, RIGHT MID SFA, RIGHT DISTAL SFA, AND RIGHT POPLITEAL ARTERY, WHICH WERE TREATED BY BALLOON ANGIOPLASTY USING THESE TWO 6 X 200 MM RANGER DRUG COATED BALLOONS. THIS WAS FOLLOWED BY PLACEMENT OF A 6 MM X 50 MM NON-BOSTON SCIENTIFIC ENDOPROSTHESIS STENT IN THE RIGHT PROXIMAL SFA AND WAS POST DILATED USING A 6 MM X 40 MM RANGER DRUG COATED BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 30%. THE EVENT WAS CONSIDERED TO BE RESOLVED AND ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2024, THE SUBJECT PRESENTED TO THE HOSPITAL WITH THE COMPLAINT OF RIGHT THIGH PAIN FOR THE PREVIOUS WEEK, INDICATIVE OF A NEW OCCLUDED STENT OR INJURY TO THE PROFUNDA. ON THE SAME DAY, RIGHT LOWER EXTREMITY ANGIOGRAM REVEALED A WIDELY PATENT PROXIMAL SFA STENT AND PROFU

  Patient problems: Arteriosclerosis/ Atherosclerosis; Obstruction/Occlusion

  MAUDE report 21768972 ↗
• MalfunctionMar 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 6.0 X 200MM, 150CM RANGER DRUG-COATED BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21629320 ↗
• MalfunctionMar 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS MINIMALLY CALCIFIED, BUT THE RECOIL WAS SEVERE. A 6.0 X 200MM, 150CM RANGER DRUG-COATED BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON RUPTURED BEFORE THE NOMINAL PRESSURE WAS INCREASED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620215 ↗
• MalfunctionMar 10, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE BECAME ENTRAPPED ON THE GUIDEWIRE. A 6.0 X 200 MM, 150 CM RANGER (DCB) BALLOON CATHETER WAS SELECTED FOR USE TO TREAT A SUPERFICIAL FEMORAL ARTERY OCCLUSION. DURING THE INSERTION, DIFFICULTY WAS ENCOUNTERED IN REMOVING AND RETRACTING THE DEVICE, AND THE DEVICE BECAME STUCK WITH THE GUIDEWIRE. THE RANGER BALLOON AND THE GUIDEWIRE WERE REMOVED AS ONE UNIT. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21563581 ↗
• MalfunctionDec 6, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26NOV2024. IT WAS REPORTED THAT THE BALLOON ISSUES OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED VESSEL IN THE LOWER EXTREMITY. A 6.0 X 200MM, 150CM RANGER DRUG-COATED BALLOON WAS SELECTED FOR ANGIOGRAM. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS LEAKING AND LOSING PRESSURE ONCE INFLATED TO 6 ATMOSPHERES. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A PINHOLE LEAK AT 12MM PROXIMAL FROM THE DISTAL TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20863275 ↗
• MalfunctionNov 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0 X 200MM, 150CM RANGER BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION, THE BALLOON RUPTURED IN A PINHOLE FORM AT THE MIDDLE. 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 20652476 ↗
• MalfunctionOct 17, 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 6.0 X 200MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR A FEW SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20474896 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL STUDY. IT WAS REPORTED THAT THROMBOTIC OCCLUSIONS OCCURRED. ON (B)(6) 2021, THE PATIENT UNDERWENT TREATMENT WITH THE RANGER DRUG-COATED BALLOONS (DCB) AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE LEFT DISTAL POPLITEAL ARTERY AND LEFT TIBIAL PERONEAL TRUNK WITH 4.0MM PROXIMAL REFERENCES VESSEL DIAMETER AND 3.5MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 40MM AND 70% STENOSIS AND WAS CLASSIFIED AS TRANSATLANTIC INTER-SOCIETY CONSENSUS (TASC) II D LESION. PRIOR TO TREATMENT, LITHOTRIPSY WAS PERFORMED USING 4 MM X 40 MM NON-BOSTON SCIENTIFIC (BSC) LITHOTRIPSY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICE, 5.0 X 120MM, 150CM RANGER DCB. POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%. THE SECOND TARGET LESION WAS LOCATED IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA), LEFT DISTAL SFA, EXTENDING UP TO LEFT PROXIMAL POPLITEAL ARTERY (POP), WITH 6MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 300MM AND 70% STENOSIS AND WAS CLASSIFIED AS A TASC II C LESION. PRIOR TO TREATMENT, LITHOTRIPSY WAS PERFORMED USING A 5.5MM X 60MM A

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20305971 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL STUDY. IT WAS REPORTED THAT THROMBOTIC OCCLUSIONS OCCURRED. ON (B)(6) 2021, THE PATIENT UNDERWENT TREATMENT WITH THE RANGER DRUG-COATED BALLOONS (DCB) AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE LEFT DISTAL POPLITEAL ARTERY AND LEFT TIBIAL PERONEAL TRUNK WITH 4.0MM PROXIMAL REFERENCES VESSEL DIAMETER AND 3.5MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 40MM AND 70% STENOSIS AND WAS CLASSIFIED AS TRANSATLANTIC INTER-SOCIETY CONSENSUS (TASC) II D LESION. PRIOR TO TREATMENT, LITHOTRIPSY WAS PERFORMED USING 4 MM X 40 MM NON-BOSTON SCIENTIFIC (BSC) LITHOTRIPSY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICE, 5.0 X 120MM, 150CM RANGER DCB. POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%. THE SECOND TARGET LESION WAS LOCATED IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA), LEFT DISTAL SFA, EXTENDING UP TO LEFT PROXIMAL POPLITEAL ARTERY (POP), WITH 6MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 300MM AND 70% STENOSIS AND WAS CLASSIFIED AS A TASC II C LESION. PRIOR TO TREATMENT, LITHOTRIPSY WAS PERFORMED USING A 5.5MM X 60MM A

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20305939 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL STUDY. IT WAS REPORTED THAT THROMBOTIC OCCLUSIONS OCCURRED. ON (B)(6) 2021, THE PATIENT UNDERWENT TREATMENT WITH THE RANGER DRUG-COATED BALLOONS (DCB) AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE LEFT DISTAL POPLITEAL ARTERY AND LEFT TIBIAL PERONEAL TRUNK WITH 4.0MM PROXIMAL REFERENCES VESSEL DIAMETER AND 3.5MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 40MM AND 70% STENOSIS AND WAS CLASSIFIED AS TRANSATLANTIC INTER-SOCIETY CONSENSUS (TASC) II D LESION. PRIOR TO TREATMENT, LITHOTRIPSY WAS PERFORMED USING 4 MM X 40 MM NON-BOSTON SCIENTIFIC (BSC) LITHOTRIPSY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICE, 5.0 X 120MM, 150CM RANGER DCB. POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%. THE SECOND TARGET LESION WAS LOCATED IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA), LEFT DISTAL SFA, EXTENDING UP TO LEFT PROXIMAL POPLITEAL ARTERY (POP), WITH 46MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 300MM AND 70% STENOSIS AND WAS CLASSIFIED AS A TASC II C LESION. PRIOR TO TREATMENT, LITHOTRIPSY WAS PERFORMED USING A 5.5MM X 60MM

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20305696 ↗