Ranger™ H74939419601010Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 08714729976141), received between Aug 24, 2021 and Jan 30, 2026 — classified as 6 injuries, 20 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05JAN2026. IT WAS REPORTED BALLOON TWISTING OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0 X 100MM, 135CM RANGER DRUG COATED BALLOON WAS ADVANCED. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON TWISTED AND IT COULD NOT BE RESOLVED EVEN AFTER PRESSURIZING UP TO 10 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED BALLOON TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24226617 ↗
• MalfunctionNov 28, 2025Material 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 RIGHT SUPERFICIAL FEMORAL ARTERY TO THE VESSEL BELOW THE KNEE. A 6.0 X 100MM, 135CM RANGER DRUG COATED BALLOON WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR 3 MINUTES. 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 23675564 ↗
• MalfunctionApr 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0 X 100MM, 135CM RANGER BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 6 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED IN A PINHOLE FORM AT 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 21864142 ↗
• MalfunctionFeb 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 6.0 X 100MM, 135CM RANGER DRUG-COATED BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR APPROXIMATELY 30-40 SECONDS, 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 21373742 ↗
• MalfunctionNov 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0 X 100MM, 135CM RANGER BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION, THE BALLOON RUPTURED IN A PINHOLE FORM AT THE TIP. 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 20666125 ↗
• MalfunctionMay 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 30% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0 X 100MM, 135CM RANGER (DCB) BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED ON THE FIRST INFLATION AT 6 ATMOSPHERES OF PRESSURE AFTER 3 SECONDS. 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 19367025 ↗
• MalfunctionDec 15, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. IN A 99% STENOSED MODERATELY TORTUOUS ANATOMY WITH SEVERE CALCIFICATION, A 6.0 X 100MM, 135 CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR AN ENDOVASCULAR THERAPY (EVT) PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) TO TREAT PERIPHERAL ARTERIAL DISEASE (PAD). AFTER ONE INFLATION FOR 3 MINUTES, THE BALLOON RUPTURED AT 6 ATM PRESSURE. THE BALLOON WAS REMOVED WITHOUT ANY PROBLEM. THERE WERE NO PATIENT COMPLICATIONS, AND THE CASE WAS COMPLETED WITH A DIFFERENT DEVICE OF THE SAME MODEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18335393 ↗
• InjuryNov 9, 2023Adverse 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 UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS AND ELUVIA DRUG ELUTING STENTS ON (B)(6) 2023 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE RIGHT PROXIMAL SUPERFICIAL ARTERY, RIGHT MID SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY WITH 6.8 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6.7 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 300 MM WITH 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO THE TREATMENT OF TARGET LESION WITH THE STUDY DEVICE, PRE-DILATION WAS PERFORMED BY USING 5 MM X 220 MM STERLING PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY USING STUDY DEVICE OF SIZES, 6 MMX 200 MM AND 6 MM X 100 MM RANGER DRUG COATED BALLOONS AND TWO 7 MM X 120 MM ELUVIA DRUG COATED STENTS. FOLLOWING POST-DILATION WAS PERFORMED USING 6 MM X 200 MM STERLING PTA BALLOON AND 6 MM X 400 MM NON-BSC BALLOON, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON (B)(6) 2023, ON THE SAME DAY OF INDEX PROCEDURE, DURING THE TREATMENT OF TARGET LESION #001 DISSECTION OF GRADE D WAS NOTED. THE FINAL RESIDUAL STENOSIS WAS

  Patient problems: Vascular Dissection

  MAUDE report 18102654 ↗
• MalfunctionOct 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A RANGER PACLITAXEL-COATED PTA BALLOON CATHETER 6MM X 100MM, 135CM WAS SELECTED FOR ENDOVASCULAR THERAPY FOR LOWER LIMB ARTERIAL STENOSIS OF THE SUPERFICIAL FEMORAL ARTERY. THE TARGET LESION HAD 95 PERCENT STENOSIS AND MODERATE CALCIFICATION. THE PHYSICIAN INSERTED THE CATHETER, AND UPON TREATMENT THE BALLOON HAD A PINHOLE RUPTURE DURING A SINGLE INFLATION AT 6 ATM FOR 10 SECONDS. THE DEVICE WAS ABLE TO BE REMOVED WITHOUT ANY PROBLEM USING THE NORMAL REMOVAL METHOD. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY USING ANOTHER DEVICE WITHOUT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18005690 ↗
• MalfunctionOct 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THERE WAS A BALLOON RUPTURE. A RANGER GLOBAL DCB OTW 6.0 X 100MM, 135CM WAS SELECTED FOR USE IN THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE TO TREAT A CASE OF PERIPHERAL ARTERY DISEASE. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY AND WAS REPORTED TO BE 100% STENOSED WITH MODERATE TORTUOSITY AND SEVERE CALCIFICATION. THE RANGER WAS ADVANCED TO THE TARGET LESION AND INFLATED ONCE TO 6 ATM FOR 5 SECONDS BEFORE THE BALLOON EXPERIENCED A PINHOLE RUPTURE AT THE TIP. THE RANGER DEVICE WAS REMOVED WITHOUT ISSUE AND REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS, AND THE PATIENT WAS IN GOOD CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17967805 ↗
• MalfunctionMay 31, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. THIS 6.0 X 100MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE IN AN ENDOVASCULAR THERAPY PROCEDURE. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 14 ATM FOR FIVE SECONDS. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17031455 ↗
• MalfunctionMay 23, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. THIS RANGER PACLITAXEL-COATED PTA BALLOON CATHETER 6.0 X 100MM, 135CM WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. THE LESION WAS LOCATED IN THE MID-SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS MILDLY TORTUOUS AND MODERATELY CALCIFIED. ATHERECTOMY WAS FIRST PERFORMED IN THE LESION, AFTER WHICH THE RESIDUAL STENOSIS WAS 20%. THEN THIS BALLOON WAS USED, AND IT RUPTURED DURING THE FIRST INFLATION AT APPROXIMATELY EIGHT ATMOSPHERES. FURTHER ATTEMPTS WERE MADE TO INFLATE THE BALLOON WITHOUT SUCCESS. THE DEVICE WAS ABLE TO BE REMOVED INTACT, THE PROCEDURE WAS COMPLETED WITH A DIFFERENT RANGER BALLOON, AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16985175 ↗
• MalfunctionMar 23, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BALLOON BECAME ENTRAPPED ON THE GUIDEWIRE. THIS RANGER GLOBAL DCB OTW 6.0 X 100MM, 135CM WAS SELECTED FOR USE IN A PERCUTANEOUS ANGIOPLASTY PROCEDURE. THE LESION WAS IN THE SUPERIOR FEMORAL ARTERY (SFA), WAS MODERATELY TORTUOUS AND CALCIFIED, AND WAS 75 PERCENT STENOSED. DURING THE PROCEDURE, THE BALLOON BECAME STUCK ON THE GUIDEWIRE. THE BALLOON AND GUIDEWIRE WERE REMOVED AS ONE UNIT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16597500 ↗
• MalfunctionDec 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE MIDDLE OF THE BALLOON EXPERIENCED A PINHOLE RUPTURE. A RANGER GLOBAL DCB OTW 6.0 X 100MM, 135CM WAS SELECTED FOR DILATION USE IN THE MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE, THE BALLOON DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION, WHICH WAS REPORTED TO BE MODERATELY CALCIFIED AND 99 PERCENT STENOSED. THE BALLOON WAS INFLATED FOR THE FIRST TIME TO 6 ATM, AND AFTER 10 SECONDS, THE MIDDLE OF THE BALLOON EXPERIENCED A PINHOLE RUPTURE. THE DEVICE WAS REMOVED ENTIRELY WITHOUT FURTHER ISSUE. THE DEVICE WAS REPLACED WITH ANOTHER RANGER GLOBAL DCB OTW 6.0 X 100MM, 135CM IN ORDER TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15894788 ↗
• InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE STUDY: IT WAS REPORTED THAT THE PATIENT EXPERIENCED TARGET-LESION REVASCULARIZATION. THE SUBJECT UNDERWENT TREATMENT WITH THREE RANGER DRUG COATED BALLOONS ON (B)(6) 2021 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT PROXIMAL COMMON FEMORAL ARTERY AND FEMORAL-ANTERIOR TIBIAL BYPASS WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 10 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5 MM. THE LESION WAS CLASSIFIED AS TASC II D, WITH A LENGTH OF 360 MM AND 90% STENOSIS. PRIOR TO TARGET LESION TREATMENT, BALLOON DILATATION WAS PERFORMED USING 3.0 MM X 60 MM STERLING PTA BALLOON. THE TREATMENT OF TARGET LESION WAS PERFORMED BY DILATATION USING STUDY DEVICES 5 MM X 40 MM, 6 MM X 100 MM AND 6 MM X 200 MM RANGER DRUG COATED BALLOONS. FOLLOWING POST DILATATION WAS PERFORMED WITH 7.0 MM X 220 MM STERLING PTA BALLOON AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON (B)(6) 2022, 315 DAYS POST-INDEX PROCEDURE THE SUBJECT DEVELOPED WORSENING PERIPHERAL ARTERY DISEASE IN LEFT COMMON FEMORAL ARTERY. IN RESPONSE, THE LEFT COMMON FEMORAL ARTERY TO ANTERIOR TIBIAL ARTERY WAS BYPASSED WITH 6 MM RINGED PROPATEN PTFE. FOLLOWING THAT, A LEFT LOWER EXTREMITY ANGIOGRAM WAS

  Patient problems: Embolism/Embolus; Obstruction/Occlusion; Restenosis; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 15823412 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE STUDY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CLAUDICATION RELATED TO WORSENING ISCHEMIA OF THE TARGET VESSEL. THE SUBJECT UNDERWENT TREATMENT WITH THREE RANGER DRUG COATED BALLOONS ON (B)(6) 2021 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT PROXIMAL COMMON FEMORAL ARTERY AND FEMORAL-ANTERIOR TIBIAL BYPASS WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 10 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5 MM. THE LESION WAS CLASSIFIED AS TASC II D, WITH A LENGTH OF 360 MM AND 90% STENOSIS. PRIOR TO TARGET LESION TREATMENT, BALLOON DILATATION WAS PERFORMED USING 3.0 MM X 40 MM STERLING PTA BALLOON. THE TREATMENT OF TARGET LESION WAS PERFORMED BY DILATATION USING STUDY DEVICES 5 MM X 40 MM, 6 MM X 100 MM AND 6 MM X 200 MM RANGER DRUG COATED BALLOONS. FOLLOWING POST DILATATION WAS PERFORMED WITH 7.0 MM X 220 MM STERLING PTA BALLOON AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON (B)(6) 2022, SUBJECT WAS NOTED WITH THE CLAUDICATION SYMPTOMS RELATED TO WORSENING ISCHEMIA NOTED IN BILATERAL LOWER EXTREMITY. ON THE SAME DAY, SUBJECT UNDERWENT LEFT LOWER EXTREMITY DUPLEX WHICH REVEALED THAT THE LEFT EXTERNAL ILIAC ARTERY WAS PATENT, COMMON FEMORA

  Patient problems: Arteriosclerosis/ Atherosclerosis; Ischemia; Restenosis; Thrombosis/Thrombus

  MAUDE report 15506397 ↗
• InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 FIRST TARGET LESION WAS IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY, MID SUPERFICIAL FEMORAL ARTERY, DISTAL SUPERFICIAL FEMORAL ARTERY, PROXIMAL POPLITEAL ARTERY AND MID POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 7 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5.5 MM WITH LESION LENGTH OF 410 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, ATHERECTOMY WAS PERFORMED FOLLOWED BY PRE DILATION WITH 4 MM X 220 MM COYOTE AND 6 MM X 220 MM STERLING PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION WITH 6 MM X 200 MM AND 6 MM X 100 MM RANGER DRUG COATED BALLOON AND IMPLANTING TWO ELUVIA DRUG ELUTING STENT OF 6 MM X 80 MM. FOLLOWING POST DILATATION WITH 7 MM X 150 MM NON-BOSTON SCIENTIFIC PTA BALLOON, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%. ON (B)(6) 2022, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2022, SUBJECT VISITED THE HOSPITAL WITH COMPLAINTS OF LIMITED ACTIVITIES

  Patient problems: Restenosis; Vascular Dissection

  MAUDE report 15407432 ↗
• MalfunctionJul 22, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT ENTRAPMENT ON GUIDEWIRE OCCURRED. THE TARGET LESION WAS LOCATED IN THE POPLITEAL ARTERY. A 6.0 X 100MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE. THE BALLOON WAS INFLATED IN THE ARTERY FOR FIVE MINUTES. UPON WITHDRAWAL, THE RANGER STUCK TO THE 018 GUIDEWIRE. THE RANGER AND THE GUIDEWIRE WERE SUCCESSFULLY REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15084985 ↗
• MalfunctionJun 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. THE 90% STENOSED TARGET LESION WAS MODERATELY CALCIFIED AND TORTUOUS AND LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE BALLOON WAS INFLATED AT 10-14ATMS FOR 20 SECONDS DURING THE FIRST INFLATION. HOWEVER, THE BALLOON RUPTURED. THE RUPTURED OCCURRED ON THE PROXIMAL SIDE FROM THE MIDDLE OF THE BALLOON, AND WAS CAUSED BY THE CALCIFIED LESION. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14846324 ↗
• MalfunctionJun 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0 X 100MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED TO TREAT THE LOWER LIMB ARTERIAL STENOSIS. HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR ONE MINUTE DURATION TIME, THE BALLOON RUPTURED IN A PINHOLE SHAPE. AFTER DECOMPRESSION, THE DEVICE WAS REMOVED FROM THE BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14844051 ↗
• MalfunctionJun 7, 2022Material 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 6.0 X 100MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR THE PROCEDURE. DURING THE FIRST INFLATION, THERE WAS A PINHOLE RUPTURE IN THE MIDDLE OF THE BALLOON AT 14 ATMOSPHERES FOR ONE MINUTE DURATION TIME. AFTER DECOMPRESSION, THE DEVICE WAS REMOVED FROM THE BODY AND A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14626588 ↗
• InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE STUDY TRIAL.IT WAS REPORTED THAT A THROMBOSIS OCCURRED AFTER A STENT WAS PLACED. THE SUBJECT UNDERWENT TREATMENT WITH TWO RANGER PACLITAXEL-COATED PTA 6.0 MM X 200 MM AND 6.0 MM X 100 MM BALLOON CATHETERS ON 17-MAR-2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. TARGET LESION WAS LOCATED IN THE RIGHT PROXIMAL, MID AND DISTAL SUPERFICIAL FEMORAL ARTERY WITH 100% STENOSIS AND WAS 280MM LONG (DIAMETER 6.0MM PROXIMAL AND 5.0MM DISTAL) AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO TARGET LESION TREATMENT, SPIDERFX EMBOLIZATION PROTECTION DEVICE WAS USED AND ATHERECTOMY WAS PERFORMED USING JETSTREAM XC FOLLOWED BY PRE DILATION WITH 5.0 MM X 220 MM STERLING BALLOON AND 5.0 MM X 200 MM VANGUARD IEP PTA BALLOON. DURING TREATMENT OF TARGET LESION WITH THE RANGER BALLOON CATHETERS THROMBOSIS WAS OBSERVED. ATHERECTOMY AND ASPIRATION WAS PERFORMED IN RESPONSE TO THE EVENT, AND THE COMPLICATION WAS RESOLVED. THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0% AND NO THROMBUS WAS SEEN IN THE TREATED VESSEL AT THE END OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 14160963 ↗
• InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL STUDY. IT WAS REPORTED THAT OCCLUSION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE ELUVIA DRUG ELUTING STENT AND RANGER DRUG COATED BALLOON ON (B)(6) 2021 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), MID SFA EXTENDING TO DISTAL SFA WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5 MM WITH LESION LENGTH OF 300 MM AND 100 % STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO TARGET LESION TREATMENT, PRE-DILATATION WAS PERFORMED WITH 4 MM X 150 MM NON-BSC BALLOON AND NON-BSC DRUG ELUTING STENT OF 6 MM X 25 MM WAS PLACED. TREATMENT OF TARGET LESION WAS PERFORMED BY PLACEMENT OF STUDY DEVICE, ELUVIA DRUG ELUTING STENT OF 6 MM X 80 MM. FOLLOWING POST-DILATION WITH STERLING BALLOON OF 6 MM X 220 MM, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. THE TARGET LESION #002 WAS IN THE RIGHT PROXIMAL POPLITEAL ARTERY, MID POPLITEAL ARTERY EXTENDING TO DISTAL POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 4 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 4 MM WITH LESION LENGTH OF 80 MM AND 100 % STENOSIS AND WAS CLASSIFIED AS TASC II D LE

  Patient problems: Arteriosclerosis/ Atherosclerosis; Obstruction/Occlusion

  MAUDE report 13878173 ↗
• MalfunctionDec 20, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THERE WAS DIFFICULTY REMOVING THE DEVICE. A RANGER PACLITAXEL-COATED BALLOON CATHETER WAS SELECTED FOR USE IN A LEFT SUPERFICIAL FEMORAL ARTERY ENDOVASCULAR THERAPY PROCEDURE AS TREATMENT FOR PERIPHERAL ARTERY DISEASE. THE PROCEDURE WAS BEING PERFORMED TO TREAT 75% STENOSIS. THE TARGET LESION CONTAINED MILD CALCIFICATION AND MODERATE TORTUOUS SEVERITY. THE PHYSICIAN WAS ABLE TO INFLATE THE BALLOON AND PERFORM THE PROCEDURE SUCCESSFULLY, HOWEVER UPON REMOVAL THE DEVICE WAS DIFFICULT TO REMOVE. IT WAS NOTED THAT A BRACHIAL APPROACH WAS UTILIZED TO REMOVE THE DEVICE. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13046335 ↗
• MalfunctionDec 8, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 6.0MM X 100MM X 135CM RANGER DRUG COATED BALLOON WAS SELECTED FOR TREATMENT IN THE SUPERFICIAL FEMORAL ARTERY. PATIENT ANATOMY CONDITIONS REVEALED MODERATE TORTUOSITY, 100% STENOSIS AND SEVERE CALCIFICATION. DURING THE PROCEDURE, THE BALLOON WAS INFLATED ONCE TO 6 ATMOSPHERES (ATMS) FOR 20 SECONDS. DURING THIS INFLATION A PINHOLE RUPTURE WAS OBSERVED ON THE BALLOON AND THE CONTRAST AGENT HAD LEAKED FORM THE TIP OF THE DEVICE. THE RUPTURED BALLOON WAS COMPLETELY REMOVED WITHOUT ANY PROBLEMS. 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 12962603 ↗