Ranger™ H74939419500610Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08714729975946), received between Jun 11, 2021 and May 4, 2026 — classified as 6 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 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 WITHOUT ANY PROBLEM USING THE NORMAL METHOD, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25064563 ↗
• MalfunctionNov 23, 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 LEFT SUPERFICIAL FEMORAL ARTERY. A 5.0 X 60MM, 135CM RANGER DRUG COATED BALLOON WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 10 ATMOSPHERES FOR 180 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23628026 ↗
• MalfunctionAug 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 60MM, 135CM RANGER BALLOON CATHETER WAS SELECTED FOR USE IN AN ENDOVASCULAR THROMBECTOMY. DURING THE FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22740267 ↗
• MalfunctionJul 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 5.0 X 60MM, 135CM RANGER GLOBAL DCB OTW BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 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 AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22556350 ↗
• MalfunctionFeb 10, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT THE RADIOPAQUE MARKERS ON EITHER SIDE OF THE BALLOON WERE MISSING. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 5.0 X 60MM, 135CM RANGER DRUG-COATED BALLOON WAS SELECTED FOR ANGIOGRAM. DURING THE PROCEDURE, THE BALLOON WAS PLACED ON THE STERILE FIELD AND FLUSHED. THE BALLOON WAS THEN INSERTED INTO THE PATIENT'S RIGHT SFA OVER AN 018 WIRE. HOWEVER, BEFORE THE BALLOON WAS INFLATED, THE PHYSICIAN NOTICED THAT THE RADIOPAQUE MARKERS ON EITHER SIDE OF THE BALLOON WERE MISSING. THE BALLOON WAS REMOVED FROM THE PATIENT AND A 5X60 STERLING BALLOON WAS USED INSTEAD TO COMPLETE THE CASE WITHOUT ANY HARM TO THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21351108 ↗
• MalfunctionApr 16, 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 5.0 X 60MM, 135CM RANGER DRUG-COATED BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 2 ATMOSPHERES FOR 1 SECOND, 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 19113692 ↗
• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE STUDY IT WAS REPORTED THAT RESTENOSIS OCCURRED, REQUIRING INTERVENTION. THE SUBJECT UNDERWENT TREATMENT WITH RANGER DRUG-COATED BALLOONS ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 60 MM AND 80% STENOSIS AND TASC II B LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, ATHERECTOMY WAS PERFORMED USING 2 MM X 1100 MM NON-BOSTON SCIENTIFIC (BSC) ATHERECTOMY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 5 MM X 150 MM RANGER DRUG-COATED BALLOON STUDY DEVICE. POST TARGET LESION TREATMENT WAS PERFORMED BY PLACEMENT OF 6 MM X 60 MM NON-BSC BARE METAL STENT AND DILATION USING 5 MM X 60 MM OF MUSTANG PTA BALLOON. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. THE SECOND TARGET LESION WAS IN THE RIGHT DISTAL SFA WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 60 MM AND 80% STENOSIS AND TASC II B LESION. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 5 MM X 60

  Patient problems: Cramp(s) /Muscle Spasm(s); Ischemia; Restenosis

  MAUDE report 18806883 ↗
• MalfunctionFeb 14, 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 5.0 X 60MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON FIRST INFLATION AT 6 ATMOSPHERES FOR SEVERAL SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18704335 ↗
• MalfunctionSep 15, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT SLOW DEFLATION OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 5.0 X 60MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE DEFLATED VERY SLOW AFTER 180 SECONDS OF EXPANSION AT 8ATM. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17756300 ↗
• MalfunctionOct 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON HAD RUPTURED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED INTERNAL CAROTID ARTERY. A 5.0 X 60MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR THE INDEX PROCEDURE. A 3.5-5.5 190CM FILTERWIRE EZ WAS SELECTED TO BE USED WITH THE RANGER BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON RUPTURED DUE TO THE SEVERE CALCIFICATION AND THE TIP OF THE FILTERWIRE WAS FLATTENED. BOTH THE RANGER BALLOON CATHETER AND THE FILTERWIRE EZ WERE REMOVED FROM THE PATIENT BODY AND REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15562816 ↗
• InjuryAug 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT THE PATIENT DEVELOPED ACUTE ISCHEMIA AND BILATERAL COMMON FEMORAL OCCLUSIONS. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE RIGHT PROFUNDA FEMORAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 4 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 4 MM WITH LESION LENGTH OF 40 MM AND 80% STENOSIS. PRE-DILATATION IN THE TARGET LESION WAS PERFORMED WITH A 4 MM X 135 MM LITHOTRIPSY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION WITH STUDY DEVICE, RANGER DRUG COATED BALLOON OF 4 MM X 40 MM. POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. THE SECOND TARGET LESION WAS IN THE RIGHT COMMON FEMORAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5 MM WITH LESION LENGTH OF 60 MM AND 70% STENOSIS. PRE-DILATATION IN THE TARGET LESION WAS PERFORMED WITH A 5 MM X 110 MM LITHOTRIPSY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION WITH STUDY DEVICE, RANGER DRUG COATED BALLOON OF 5 MM X 60 MM. POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 25%.

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 15179982 ↗
• InjuryAug 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT THE PATIENT DEVELOPED ACUTE ISCHEMIA AND BILATERAL COMMON FEMORAL OCCLUSIONS. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE RIGHT PROFUNDA FEMORAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 4 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 4 MM WITH LESION LENGTH OF 40 MM AND 80% STENOSIS. PRE-DILATATION IN THE TARGET LESION WAS PERFORMED WITH A 4 MM X 135 MM LITHOTRIPSY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION WITH STUDY DEVICE, RANGER DRUG COATED BALLOON OF 4 MM X 40 MM. POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. THE SECOND TARGET LESION WAS IN THE RIGHT COMMON FEMORAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5 MM WITH LESION LENGTH OF 60 MM AND 70% STENOSIS. PRE-DILATATION IN THE TARGET LESION WAS PERFORMED WITH A 5 MM X 110 MM LITHOTRIPSY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION WITH STUDY DEVICE, RANGER DRUG COATED BALLOON OF 5 MM X 60 MM. POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 25%.

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 15179956 ↗
• InjuryJul 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE STUDY. IT WAS REPORTED THAT A DISSECTION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE TWO RANGER DRUG-COATED BALLOONS ON (B)(6) 2021 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) EXTENDING TO LEFT PROXIMAL POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 4 MM. THE LESION LENGTH OF 250 MM WITH 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO TARGET LESION TREATMENT, PRE-DILATATION WAS PERFORMED WITH A NON-BSC PTA BALLOON 3 MM X 200 MM, THEN TREATMENT WAS PERFORMED USING RANGER DRUG COATED BALLOONS OF 4.0 MM X 200 MM AND 5.0 MM X 60 MM. POST-TARGET LESION TREATMENT, BALLOON DILATION WAS PERFORMED WITH A NON-BSC PTA BALLOON OF 4 MM X 120 MM AND 5 MM X 120 MM. FOLLOWING THE TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON (B)(6) 2021, DURING THE INDEX PROCEDURE, A DISSECTION OF GRADE B IN THE TARGET LESION WAS NOTED DUE TO STUDY DEVICES AND A NON-BSC BARE METAL STENT WAS DEPLOYED IN RESPONSE. ON THE SAME DAY, SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON CLOPIDOGREL AND ASPIRIN.

  Patient problems: Vascular Dissection

  MAUDE report 15068023 ↗
• InjuryJun 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT CLAUDICATION AND OCCLUSION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH RANGER DRUG COATED BALLOONS (DCB) AND ELUVIA DRUG ELUTING STENT ON 12-APR-2022 AS PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS LOCATED IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA), LEFT PROXIMAL POPLITEAL ARTERY, MID POPLITEAL ARTERY EXTENDING TO DISTAL POPLITEAL ARTERY. THE LESION HAD A PROXIMAL REFERENCE VESSEL DIAMETER OF 5MM, DISTAL REFERENCE VESSEL DIAMETER OF 5MM, LESION LENGTH OF 190MM, 100% STENOSIS AND WAS CLASSIFIED AS TASC II C LESION. PRIOR TO TARGET LESION TREATMENT, A NON BOSTON SCIENTIFIC (BSC) EMBOLIZATION PROTECTION DEVICE WAS USED AND PRE DILATION WAS PERFORMED WITH A 5MM X 150MM AND 4MM X 40MM NON-BSC BALLOONS. TREATMENT OF TARGET LESION WAS PERFORMED BY THE FOLLOWING RANGER DCB STUDY DEVICES: 4MM X 40MM, 5MM X 200MM AND 5MM X 60MM, RESPECTIVELY, FOLLOWED BY PLACEMENT OF A 6MM X 60MM ELUVIA DRUG ELUTING STUDY STENT. FOLLOWING POST DILATION WITH 5MM X 20MM NC EMERGE BALLOON, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 30%. ON 25-APR-2022, THE SUBJECT VISITED THE HOSPITAL WITH SYMPTOMS RELATED TO CLAUDICATION. SEGMENTAL PRESSU

  Patient problems: Arteriosclerosis/ Atherosclerosis; Obstruction/Occlusion; Unspecified Vascular Problem

  MAUDE report 14639257 ↗
• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) STUDY. IT WAS REPORTED THE PATIENT EXPERIENCED RIGHT FOOT ISCHEMIA. THE SUBJECT WAS ENROLLED IN THE (B)(6) STUDY ON (B)(6) 2022 AND THE PATIENT UNDERWENT TREATMENT WITH RANGER PACLITAXEL-COATED PTA BALLOON CATHETER ON THE SAME DAY. TARGET LESION WAS 60MM LONG WITH 100% STENOSIS AND LOCATED IN THE RIGHT PROXIMAL, MID AND DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE PROXIMAL AN DISTAL REFERENCE VESSEL DIAMETER WERE BOTH 5MM. PRIOR TO TARGET LESION TREATMENT WITH RANGER 5.0 X 60MM X 135CM, LITHOTRIPSY WAS PERFORMED WITH SHOCKWAVE AND PRE-DILATATION PERFORMED WITH THE STUDY DEVICE. THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE UNKNOWN. ON (B)(6) 2022, THE SUBJECT PRESENTED WITH SYMPTOMS OF COLD AND NUMBNESS IN THE RIGHT FOOT RELATED TO ISCHEMIA. IN RESPONSE TO THE EVENT, RIGHT LEG ANKLE BRACHIAL INDEX WAS PERFORMED TO COMPARE BLOOD PRESSURE IN UPPER AND LOWER LIMBS AND A DRUG-COATED BALLOON ANGIOPLASTY WAS PERFORMED IN THE RIGHT SFA. ON (B)(6) 2022, THE SUBJECT HAD 100% STENOSIS IN THE RIGHT SFA AND WAS TREATED WITH A BARE METAL STENT PLACEMENT. NO FURTHER INFORMATION WAS AVAILABLE AT THIS TIME.

  Patient problems: Ischemia; Numbness; Obstruction/Occlusion

  MAUDE report 13700578 ↗
• MalfunctionDec 16, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THE 5.0 X 60MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS ADVANCED AND WAS INITIALLY INFLATED TO 10ATM. DURING THE FIRST INFLATION AFTER 10 SECONDS, THE BALLOON RUPTURED AT 10ATMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13022762 ↗
• MalfunctionNov 24, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 5.0MM X 60MM X 135CM RANGER BALLOON WAS SELECTED TO TREAT LOWER LIMB ARTERY STENOSIS IN THE SUPERFICIAL FEMORAL ARTERY. PATIENT ANATOMY CONDITIONS REVEALED 100% STENOSIS AND SEVERE CALCIFICATION. THE BALLOON WAS INFLATED ONCE TO 8 ATMOSPHERES (ATM) WHEN IT RUPTURED. THE BALLOON WAS REMOVED WITHOUT ANY PROBLEM 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 12872686 ↗
• MalfunctionJun 11, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A 5.0 X 60MM, 135CM RANGER DRUG-COATED BALLOON WAS SELECTED FOR IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE TARGET LESION WAS 100% STENOSED, CALCIFICATION WAS MODERATE AND IT WAS NOT TORTUOUS. DURING THE FIRST INFLATION FOR ONE MINUTE AT 8 ATM, THE BALLOON RUPTURED. ANOTHER DEVICE WHICH WAS THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11984738 ↗