Sterling™ H74939032602210Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 08714729845485), received between Aug 19, 2019 and Feb 6, 2026 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (23 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0X220X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INITIAL INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE TARGET LESION, WHICH WAS 100% STENOSED, WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277403 ↗
• MalfunctionMay 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON WAS TORN. A 6.0 X 220 X 150 STERLING? BALLOON CATHETER WAS ADVANCE FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS TORN AT 6 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061910 ↗
• MalfunctionNov 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED, THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION, WAS LOCATED IN AN INTERNAL SHUNT GRAFT ANASTOMOSIS. IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 6.0X220X150-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR SEVERAL 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 20663650 ↗
• MalfunctionOct 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. TWO 6.0X220X150 STERLING BALLOON CATHETERS WERE ADVANCED FOR DILATION. DURING THE PROCEDURE, BOTH BALLOONS RUPTURED AT 4 ATMOSPHERES. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20463057 ↗
• MalfunctionOct 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. TWO 6.0X220X150 STERLING BALLOON CATHETERS WERE ADVANCED FOR DILATION. DURING THE PROCEDURE, BOTH BALLOONS RUPTURED AT 4 ATMOSPHERES. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20463048 ↗
• MalfunctionAug 21, 2024Material Rupture; Material Twisted/Bent; Material Rupture; Material Twisted/Bent

  IT WAS REPORTED THAT THE BALLOON WAS RUPTURED OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0X220X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FOURTH INFLATION AT 06 ATMOSPHERES FOR 30 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 20021397 ↗
• MalfunctionAug 21, 2024Material Rupture; Material Twisted/Bent; Material Rupture; Material Twisted/Bent

  IT WAS REPORTED THAT THE BALLOON WAS RUPTURED OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0X220X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FOURTH INFLATION AT 14 ATMOSPHERES FOR 30 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 20020677 ↗
• MalfunctionAug 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. FOLLOWING ATHERECTOMY WITH A 2.0 ROTABLATOR, A 6.0X220X150-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION OF THE 80% STENOSED TARGET LESION LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. HOWEVER, DURING THE INITIAL INFLATION AT 10 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED. THE BALLOON WAS PULLED OUT AND COMPLETELY REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17628877 ↗
• MalfunctionAug 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0 X 220 X 150-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, AFTER THE BALLOON WAS BEING INFLATED ON THE FIRST INFLATION AT 6 ATMOSPHERES FOR 30 SECONDS, THE PRESSURE WENT DOWN AND WOULD NOT HOLD PRESSURE. THE DEVICE WAS REMOVED AND BURST WAS NOTED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER 6 X 220 STERLING BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292567 ↗
• MalfunctionJul 5, 2022Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT BALLOON SPLIT OCCURRED. THE 70-80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0X220X150MM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, IT WAS NOTICED THAT THE BALLOON DID NOT INFLATE. THE DEVICE WAS SLOWLY REMOVED FROM THE PATIENT AND IT WAS FOUND THAT THE BALLOON WAS SPLIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER STERLING BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14915239 ↗
• MalfunctionApr 6, 2022Material Rupture; Material Integrity Problem; Material Rupture; Material Integrity Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0X220X150-HYBRID STERLING BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, UPON OPENING THE PACKAGE, IT WAS NOTICED THAT THE BALLOON WAS WRAPPED STRANGELY AND TWISTED ON DELIVERY SHAFT. THE BALLOON WAS INITIALLY INFLATED BUT DID NOT INFLATE PROPERLY WITH A SIGNIFICANT WAIST AT THE MID POINT OF THE BALLOON. AFTER DEFLATION AND RE-INFLATION OF THE BALLOON, THE WRAP/WAIST RESOLVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14025150 ↗
• MalfunctionMar 23, 2022Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01-MAR-2022. IT WAS REPORTED THAT BALLOON DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT LEG ANGIOGRAM. A 6.0X220X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. THE PHYSICIAN WAS ATTEMPTING TO PLASTY A DISEASED PORTION OF SUPERFICIAL FEMORAL ARTERY PRIOR TO IVUS IMAGING TO BE CERTAIN THE CATHETER WOULD TRACK. UNFORTUNATELY, THE BALLOON AT SOME POINT IN THE LESION WAS DEFECTIVE. THE PHYSICIAN UTILIZED ANOTHER SHORTER BALLOON CATHETER AND A RANGER DCB TO COMPLETE THE CASE WITHOUT ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13866012 ↗
• MalfunctionFeb 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0X220X150-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT NOMINAL PRESSURE FOR LESS THAN 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13497584 ↗
• MalfunctionFeb 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0X220X150-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT NOMINAL PRESSURE FOR LESS THAN 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT PROBLEM. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13496645 ↗
• MalfunctionFeb 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0 X 220 X 150-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT NOMINAL PRESSURE FOR LESS THAN 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13496135 ↗
• MalfunctionOct 26, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0X220X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND ANOTHER 6.0X150X150 STERLING BALLOON CATHETER WAS ADVANCED BUT THE BALLOON ALSO RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT SEVERELY CALCIFIED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. BOTH STERLING BALLOONS RUPTURED DURING THE INITIAL INFLATION AT 6 ATMOSPHERES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698485 ↗
• MalfunctionAug 3, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. A 6.0X220X150-HYBRID STERLING BALLOON CATHETER WAS ADVANCED OVER A 0.009 ROTAWIRE GUIDEWIRE FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON CATHETER WOULD NOT TRACK WHEN IT WAS ATTEMPTED TO BE REMOVED OVER THE GUIDEWIRE. A 0.014 V-14 GUIDEWIRE WAS PLACED BUT THE BALLOON CATHETER WAS STILL UNABLE TO BE REMOVED. THE PHYSICIAN NOTED THAT IT FELT TIGHT. THE ENTIRE SYSTEM WAS REMOVED AND THE LESION WAS REWIRED. A 7.0X150X150-HYBRID STERLING BALLOON CATHETER WAS USED AND REMOVED WITHOUT INCIDENT; HOWEVER, IT WAS DIFFICULT TO ADVANCE THROUGH THE SHEATH WHEN IT WAS REINSERTED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12272074 ↗
• MalfunctionJun 30, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A SUPERFICIAL FEMORAL ARTERY. A 6.0X220X150-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED DURING SECOND INFLATION AT 4 ATMOSPHERES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12096752 ↗
• MalfunctionMay 5, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0X220X150-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 14 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE INFLATION OF THIS DEVICE WAS ENOUGH TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11779093 ↗
• MalfunctionFeb 19, 2021Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11-FEB-2021. IT WAS REPORTED THAT BALLOON DAMAGE OCCURRED. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0X220X150-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON INITIAL INFLATION UNDER FLUOROSCOPY, THE BALLOON WAS TWISTING APPROXIMATELY 5CM FROM THE PROXIMAL MARKER. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR HARM WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11349787 ↗
• MalfunctionJul 6, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0X220X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10237658 ↗
• MalfunctionJun 8, 2020Material 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. A 6.0X220X150 - HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE BALLOON WAS RUPTURED DURING FIRST INFLATION AT 6 ATMOSPHERES FOR 5 SECONDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10127663 ↗
• InjuryApr 9, 2020Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE AND BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 6.0X220X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION, THE BALLOON RUPTURED CIRCUMFERENTIAL AND A PIECE OF THE BALLOON REMAINED IN THE PATIENT. THE PROCEDURE TOOK AN EXTRA THREE HOURS OF TRYING TO REMOVE THE PIECE OF THE BALLOON BY SNARE AND ALSO A NON-BSC FILTER WIRE THAT SHEARED OFF IN THE HEAVILY CALCIFIED LESION. THE FRAGMENTED PIECE HAD TO BE LEFT IN THE PATIENT AND A COVERED STENT WAS DEPLOYED TO JAIL IT UP AGAINST THE WALL. THE FILTER WIRE ALSO TRIED TO BE RETRIEVED AND WAS UNSUCCESSFUL, SO IT WAS JAILED UP AGAINST THE WALL ALONG WITH THE BALLOON FRAGMENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9943481 ↗
• MalfunctionJan 2, 2020Deflation Problem; Material Deformation; Deflation Problem; Material Deformation

  IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED. THE TAGET LESION WAS LOCATED IN A VESSEL IN THE LEFT LEG. A 6.0X220X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE CONTRAST AGENT USED WAS OMNI 300 WITH A CONTRAST RATIO OF 50/50 WITH SALINE. HOWEVER, DURING INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS, THE BALLOON DID NOT INFLATE PROPERLY AND APPEARED TO BE DEFORMED. BALLOON DEFLATION DIFFICULTIES WERE ENCOUNTERED BUT EVENTUALLY THE BALLOON WAS REMOVED FULLY DEFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9538847 ↗
• MalfunctionOct 17, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. TWO 6.0X220X150-HYBRID STERLING BALLOON CATHETERS WERE USED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOONS RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE. IT WAS FURTHER REPORTED THAT THE LESION WAS SEVERELY CALCIFIED AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 1 MINUTE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9203096 ↗