Ranger™ H74939419600610Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 08714729976103), received between May 19, 2021 and Mar 3, 2026 — classified as 12 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Material 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 60MM, 135CM RANGER BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 8 ATMOSPHERES FOR SEVERAL SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24503122 ↗
• MalfunctionNov 24, 2025Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE PERIPHERAL ARTERY. A 6.0 X 60MM, 135CM RANGER BALLOON CATHETER WAS ADVANCED FOR DILATION IN A LOWER LEG ANGIOPLASTY. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS STUCK IN THE 6FR SHEATH AND BROKE. AN XRAY WAS PERFORMED, AND IT WAS CONFIRMED THAT NO DEVICE FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE BALLOON WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS PROLONGED AND WAS COMPLETED WITH ANOTHER BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23639712 ↗
• MalfunctionAug 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0MM X 60MM, 135CM RANGER BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT NOMINAL PRESSURE FOR 5 SECONDS. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22853919 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Failure to Deflate; Adverse Event Without Identified Device or Use Problem; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0 X 60MM, 135CM RANGER BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS INFLATED ONCE FOR 3 MINUTES. DURING REMOVAL, IT WAS NOTED THAT THE BALLOON WOULD NOT DEFLATE. A WIRE WAS USED TO PIERCE AND TEAR THE BALLOON, THUS DRAINING THE SOLUTION INSIDE THE BALLOON, DEFLATE IT AND REMOVING IT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686341 ↗
• MalfunctionJul 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED PERIPHERAL ARTERY. A 6.0 X 60MM,135CM RANGER GLOBAL DCB BALLOON CATHETER WAS SELECTED FOR USE. THE BALLOON COATED ONCE AND WAS NOT FULLY INFLATED BEFORE IT RUPTURED TO 12 ATMOSPHERES FOR A COUPLE OF SECONDS. THE BALLOON WAS REMOVED WITHOUT ANY PROBLEM, AND ALL THE PIECES WERE INTACT, 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 22561906 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT EXPERIENCED LEFT LOWER EXTREMITY GANGRENE, REQUIRING INTERVENTION AND AMPUTATION. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON ON (B)(6) 2024 AS A PART OF A CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 6 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6 MM DISTAL REFERENCE VESSEL DIAMETER WITH 20 MM LESION LENGTH WITH 90% STENOSIS AND WAS CLASSIFIED AS TRANSATLANTIC INTER-SOCIETY CONSENSUS (TASC) II CLASS A LESION. PRIOR TO THE TREATMENT OF TARGET LESION, LITHOTRIPSY WAS PERFORMED USING 6 MM X 60 MM SHOCKWAVE MEDICAL DEVICE AND BALLOON DILATION WAS PERFORMED USING 6 MM X 100 MM NON-BOSTON SCIENTIFIC DRUG COATED BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 6 MM X 60 MM RANGER DRUG COATED BALLOON, STUDY DEVICE. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON CLOPIDOGREL. ON (B)(6) 2024, THE SUBJECT UNDERWENT LEFT COMMON FEMORAL ARTERY TO POSTERIOR TIBIAL ARTERY BYPASS FOR GANGRENOUS LEFT TOES WITH POPLITEAL AND TIBIAL DISEASE. ON (B)(6) 2024, THE SUBJECT UNDERWENT LEFT FOOT T

  Patient problems: Necrosis

  MAUDE report 22056043 ↗
• InjuryApr 29, 2025Difficult to Remove; Detachment of Device or Device Component; Failure to Deflate; Difficult to Remove; Detachment of Device or Device Component; Failure to Deflate

  IT WAS REPORTED VIA MEDWATCH REPORT # MW5168059 THAT ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE A PARTIALLY DEFLATED BALLOON. A 6.0 X 60 MM, 135 CM RANGER DRUG- COATED BALLOON (DCB) WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. THE TARGET LESION WAS 85% STENOSED, MILDLY TORTUOUS, NON-CALCIFIED. MODERATELY FIBROTIC PLAQUE WAS PRESENT. A 5F SHEATH WAS PLACED UP AND OVER INTO THE CONTRALATERAL SFA. THE RANGER (DCB) WAS DILATED FOR 3 MINUTES. UPON REMOVAL, THE HUB DETACHED FROM THE CATHETER. AS A RESULT, THE BALLOON REMAINED SLIGHTLY INFLATED. ATTEMPTS WERE MADE TO COMPRESS THE BALLOON WHICH INCLUDED USING A BUDDY WIRE AND PLACING BALLOON NEXT TO THE RANGER (DCB). EVENTUALLY, THE 5F SHEATH AND PARTIALLY DEFLATED RANGER (DCB) WERE BROUGHT ALL THE WAY BACK TO THE LEFT COMMON FEMORAL ARTERY (CFA). UNDER ULTRASOUND GUIDANCE, A MICROPUNCTURE NEEDLE WAS USED TO POP THE BALLOON WHICH ALLOWED IT TO BE DELIVERED TO THE SHEATH AND REMOVED OVER A .018 GUIDEWIRE THAT WAS STILL IN PLACE. ALL DEVICES WERE REMOVED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930343 ↗
• MalfunctionApr 22, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 6.0 X 60MM, 135CM RANGER DRUG-COATED BALLOON CATHETER WAS ADVANCED FOR LEG BALLOON ANGIOPLASTY PROCEDURE. HOWEVER, THE DEVICE BROKE OFF DURING THE PROCEDURE. THE BROKEN PART WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED USING ALTERNATE DEVICE. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885350 ↗
• InjuryApr 11, 2025Detachment of Device or Device Component; Failure to Deflate; Detachment of Device or Device Component; Failure to Deflate

  IT WAS REPORTED THAT BALLOON DEFLATION PROBLEM OCCURRED, AND ADDITIONAL INTERVENTION WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE POPLITEAL ARTERY. A 6.0 X 60MM, 135CM RANGER BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE HUB OF THE BALLOON CAME OFF THE CATHETER. THE PHYSICIAN BEGAN TO PIN PULL THE BALLOON WHILE IT WAS STILL INFLATED. THE PHYSICIAN TRIED TO SLIDE THE HUB BACK ON AND DEFLATE THE BALLOON BUT WAS UNSUCCESSFUL. A WIRE AND BALLOON WERE THEN PLACED ALONGSIDE THE INFLATED RANGER TO DEFLATE IT BUT WAS ALSO UNSUCCESSFUL. THE BALLOON WAS BROUGHT BACK TO THE OPENING OF THE SHEATH AND A WIRE WAS PLACED IN THE SHEATH TO TRY AND POP THE BALLOON BUT WAS AGAIN UNSUCCESSFUL. THE SHEATH AND THE INFLATED BALLOON WERE THEN BROUGHT BACK TO THE ACCESS SITE. USING ULTRASOUND, THE INFLATED BALLOON WAS LOCATED IN THE ARTERY AND WAS PUNCTURED THROUGH THE SKIN WITH THE NEEDLE THAT WAS USED TO GIVE LOCAL SEDATION. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21827267 ↗
• MalfunctionMar 17, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED. THE 90% SOFT STENOSED TARGET LESION WAS LOCATED IN A LOWER EXTREMITY ARTERY WITH STRAIGHT GEOMETRY. THE LESION MEASURED 6MM IN DIAMETER AND WAS APPROXIMATELY 50MM IN LENGTH. PRE-DILATION WAS PERFORMED WITH A NON-BSC SCORING BALLOON. THE 6.0 X 60MM, 135CM RANGER DRUG-COATED BALLOON WAS THEN ADVANCED ACROSS THE LESION. THE BALLOON WAS INFLATED ONCE TO TREAT THE LESION AND THEN COULD NOT BE DEFLATED. TO ASSIST WITH DEFLATION, THE BALLOON WAS INFLATED TWO ADDITIONAL TIMES AND DIFFERENT INFLATION DEVICES AND SYRINGES WERE USED, BUT THE ATTEMPTS WERE NOT SUCCESSFUL. THEY INFLATED THE BALLOON AGAIN, THIS TIME TO ITS RUPTURE POINT, AFTER WHICH IT WAS REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21624943 ↗
• MalfunctionFeb 24, 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 60MM, 135CM RANGER DRUG-COATED BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445083 ↗
• MalfunctionFeb 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0 X 60MM, 135CM RANGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 8 ATMOSPHERES FOR 60 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21427714 ↗
• MalfunctionJan 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 6.0 X 60MM, 135CM RANGER DRUG-COATED BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 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 21125089 ↗
• MalfunctionNov 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0 X 60MM, 135CM RANGER BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION, THE BALLOON RUPTURED IN A PINHOLE FORM. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE 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 20766868 ↗
• InjuryJun 20, 2024Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT BALLOON FAILED TO DEFLATE, REQUIRING ADDITIONAL DEVICE FOR REMOVAL. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED VESSEL. A 6.0 X 60MM, 135CM RANGER DRUG-COATED BALLOON WAS SELECTED FOR POST INTRAVASCULAR LITHOTRIPSY (IVL) THERAPY. HOWEVER, AFTER THE BALLOON WAS INFLATED FOR 3 MINUTES, IT WAS NOTED THAT THE BALLOON WOULD NOT DEFLATE. THE BALLOON WOULD NOT DEFLATE ENOUGH TO BE REMOVED FROM A 6F SHEATH EVEN AFTER MULTIPLE ATTEMPTS. THE PHYSICIAN ENDED UP TAKING A MICRONEEDLE AND PUNCTURING THE ARTERY TO RUPTURE THE BALLOON. THE BALLOON WAS THEN REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED USING THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19578807 ↗
• MalfunctionMar 14, 2024Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE AND WAS DIFFICULT TO REMOVE. THE 95% STENOSED TARGET LESION WAS LOCATED IN MODERATELY TORTUOUS AND SEVERELY CALCIFIED ARTERY. A 6.0 X 60MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR ENDOVASCULAR THERAPY PROCEDURE. DURING THE PROCEDURE, THE BALLOON WAS INITIALLY INFLATED AT NOMINAL PRESSURE FOR 180 SECONDS. UPON DEFLATION, THE BALLOON DID NOT COMPLETELY DEFLATE. THE BALLOON WAS ATTEMPTED TO BE DEFLATED FOR 10 SECONDS, AND UPON REMOVAL, RESISTANCE OCCURRED. THE ENTIRE SYSTEM WAS THEN REMOVED, AND THE PROCEDURE WAS COMPLETED. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18908671 ↗
• MalfunctionJan 30, 2024Difficult to Remove; Difficult to Advance; Failure to Deflate; Difficult to Remove; Difficult to Advance; Failure to Deflate

  S2444 ELEGANCE. IT WAS REPORTED THAT THE BALLOON WAS UNABLE TO BE FULLY DEFLATED. 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 LEFT COMMON FEMORAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 7 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 6.5 MM WITH LESION LENGTH OF 60 MM AND 70% STENOSIS AND WAS CLASSIFIED AS TASC II A LESION. PRIOR TO TARGET LESION TREATMENT, LITHOTRIPSY WAS PERFORMED USING A NON-BOSTON SCIENTIFIC DEVICE AND TREATMENT OF TARGET LESION WAS PERFORMED BY STUDY DEVICE OF 7.0 MM X 80 MM RANGER DRUG COATED BALLOON. POST TREATMENT THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. THE TARGET LESION #002 WAS IN THE RIGHT COMMON FEMORAL ARTERY, RIGHT OSTIAL SUPERFICIAL FEMORAL ARTERY (SFA) EXTENDING INTO RIGHT PROXIMAL SFA WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 6.5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 6.0 MM WITH LESION LENGTH OF 80 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO TARGET LESION TREATMENT, A NON-BOSTON SCIENTIFIC EMBOLIZATION PROTECTION DEVICE WAS PLACED, FOLLOWED BY ATHERECTOMY AND LITHOTRIPSY USING TWO NON-BO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607588 ↗
• MalfunctionAug 7, 2023Material Rupture; Failure to Deflate; Material Rupture; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE, THEN WAS BELIEVED TO HAVE BROKEN. THIS 6.0 X 60MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE IN A VASCULAR INTERVENTION PROCEDURE FOR PERIPHERAL ARTERY DISEASE. THIS DEVICE WAS INFLATED FOR THREE MINUTES DURING THE PROCEDURE. SEVERAL DIFFERENT ATTEMPTS WERE MADE TO DEFLATE THE BALLOON FOR SEVERAL MINUTES WITHOUT SUCCESS. THEN IT WAS BELIEVED THAT THE BALLOON MAY HAVE BROKEN, AND THE BALLOON WAS ABLE TO BE PULLED BACK INTO THE SHEATH AND OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469611 ↗
• MalfunctionJun 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED AND 100% STENOSED SUPERFICIAL FEMORAL ARTERY. A 6.0 X 60MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE TO TREAT LOWER LIMB ARTERY STENOSIS. DURING THE FIRST INFLATION, HOWEVER, THE BALLOON RUPTURED IN A PINHOLE SHAPE AT A PRESSURE OF 14 ATMOSPHERES AFTER 10 SECONDS INFLATION TIME. THE BALLOON CATHETER WAS ABLE TO BE REMOVED USING THE NORMAL METHOD, 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 17170956 ↗
• InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE STUDY IT WAS REPORTED THAT A TARGET LESION REVASCULARIZATION (TLR) OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER PACLITAXEL-COATED PTA BALLOON CATHETERS ON (B)(6)2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), LEFT MID-SFA EXTENDING UP TO LEFT DISTAL-SFA WITH 6.0 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6.0 MM DISTAL REFERENCE VESSEL DIAMETER. THE LESION LENGTH WAS 250 MM AND 99% STENOSIS (CLASSIFIED AS TASC II C LESION). PRIOR TO TARGET LESION TREATMENT WITH THE STUDY DEVICE, ATHERECTOMY WAS PERFORMED BY USING 2.1 MM X 1350 MM JETSTREAM XC ATHERECTOMY DEVICE AND PRE-DILATION WAS PERFORMED BY USING 5.0 MM X 200 MM MUSTANG PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING SIZES OF 6.0 MM X 60 MM AND 6.0 MM X 200 MM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER STUDY DEVICES. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON (B)(6)2022, THE SUBJECT WAS DISCHARGED FROM HOSPITAL ON ASPIRIN. ON (B)(6)2023, THE SUBJECT NOTED HAVING SYMPTOMS RELATED TO CLAUDICATION. ON (B)(6)2023, SUBJECT VISITED THE HOSPITAL FOR LEFT LEG ANGIOGRAPHY, HOWEVER IT WA

  Patient problems: Arteriosclerosis/ Atherosclerosis; Restenosis

  MAUDE report 17127026 ↗
• MalfunctionMar 24, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE BALLOON LENGTH WAS SHORTER THAN EXPECTED. THIS RANGER GLOBAL DCB OTW 6.0 X 60MM, 135CM WAS SELECTED FOR USE IN A PERCUTANEOUS ANGIOPLASTY PROCEDURE. THE LESION WAS IN THE SUPERIOR FEMORAL ARTERY (SFA), WAS MILDLY CALCIFIED, HAD MODERATE TORTUOSITY, AND WAS 95 PERCENT STENOSED. DURING FLUOROSCOPY DURING THE PROCEDURE, IT WAS SUSPECTED THAT THE BALLOON LENGTH WAS 5.5CM INSTEAD OF THE EXPECTED 6CM. AFTER THE PROCEDURE THE BALLOON LENGTH WAS MEASURED OUTSIDE THE BODY AND WAS 5.5CM. THERE WAS NO PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16615993 ↗
• InjuryMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT EXPERIENCED ANAPHYLAXIS. THIS RANGER GLOBAL DCB OTW 5.0 X 100MM, 135CM WAS SELECTED FOR USE IN AN ENDOVASCULAR THROMBECTOMY PROCEDURE. THE LESION WAS IN THE SUPERIOR FEMORAL ARTERY (SFA), AND THE LESION CHARACTERISTICS WERE UNKNOWN. THE PATIENT EXPERIENCED ANAPHYLAXIS AFTER THE PROCEDURE WAS COMPLETED. IT WAS NOTED THAT THE PATIENT WAS ALLERGIC TO CONTRAST AGENT AND THAT CARBON DIOXIDE ANGIOGRAPHY WAS PERFORMED THAT DAY. TWO RANGER BALLOONS WERE USED THAT DAY, AND IT WAS UNKNOWN WHETHER THIS WAS CAUSED BY THE RANGER BALLOONS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16594187 ↗
• MalfunctionJan 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PINHOLE BALLOON RUPTURE OCCURRED. A RANGER GLOBAL DCB OTW 6.0 X 60MM, 135CM WAS SELECTED FOR USE. THE MODERATELY TORTUOUS TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WAS REPORTEDLY SEVERELY CALCIFIED AND 99 PERCENT STENOSED. THE BALLOON WAS ADVANCED TO THE TARGET LESION AND INFLATED TO 6 PSI FOR 20 SECONDS BEFORE THE MIDDLE OF THE BALLOON EXPERIENCED A PINHOLE RUPTURE. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. THE RANGER WAS REPLACED WITH ANOTHER RANGER BALLOON AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16114271 ↗
• MalfunctionNov 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A RANGER GLOBAL DCB OTW 6.0 X 60MM, 135CM WAS SELECTED FOR USE IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE, THE BALLOON WAS ADVANCED TO THE TARGET LESION, WHICH WAS 50% STENOSED AND HAD MODERATE CALCIFICATION AND TORTUOSITY. THE BALLOON WAS INFLATED ONCE TO 12 ATM BEFORE IT RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15756260 ↗
• InjuryOct 28, 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 322 DAYS POST INDEX PROCEDURE WITH THE RANGER (DCB). THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG-COATED BALLOON ON 11-NOV-2021 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH 6.00 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6.00 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 60 MM WITH 80% STENOSIS. PRIOR TO TARGET LESION TREATMENT WITH THE STUDY DEVICE, PRE-DILATION WAS PERFORMED USING 5.0 MM X 40 MM STERLING PTA BALLOON. THE TREATMENT OF TARGET LESION WAS PERFORMED BY DILATATION USING STUDY DEVICE 6 MM X 60 MM, RANGER DRUG COATED BALLOON. FOLLOWING POST DILATATION, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 5%. ON (B)(6) 2022, THE SUBJECT VISITED THE HOSPITAL WITH SYMPTOMS RELATED TO RIGHT LEG CLAUDICATION WITH RIGHT GREATER THAN LEFT AND PRIOR RIGHT PARTIAL GREAT TOE AND SECOND TOE COMPLETE AMPUTATION. ON THE SAME DAY, THE SUBJECT UNDERWENT LOWER EXTREMITY ANGIOGRAPHY WHICH REVEALED SEVERE BILATERAL SFA STENOSIS. ON (B)(6) 2022, 322 DAYS POST INDEX PROCEDURE, 70% STENOSIS NOTED IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY WAS

  Patient problems: Restenosis

  MAUDE report 15693600 ↗