Sterling™ H74939031502210Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 08714729859475), received between Aug 15, 2018 and Jan 29, 2025 — classified as 73 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (70 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 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. A 5.0MMX220MMX150CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE MIDDLE PART OF THE BALLOON RUPTURED UPON INITIAL INFLATION AT 5 ATMOSPHERES FOR 2 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21270181 ↗
• MalfunctionDec 9, 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 5.0MMX220MMX150CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON THIRD INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878900 ↗
• MalfunctionOct 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED CEPHALIC VEIN. A 5.0MMX220MMX150CM (4F) STERLING BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION AT 6 ATMOSPHERES FOR 3 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 20504541 ↗
• MalfunctionAug 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0MMX220MMX150CM STERLING BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 3 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 19989474 ↗
• MalfunctionAug 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0MMX220MMX150CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR 3 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19960208 ↗
• MalfunctionJun 12, 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 RIGHT SUPERFICIAL FEMORAL ARTERY. A 5.0MMX220MMX150CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURE UPON THIRD INFLATION AT 14 ATMOSPHERES FOR 3 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19521722 ↗
• MalfunctionMar 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 5.0MMX220MMX150CM (4F) STERLING BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION AT 6 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18844979 ↗
• MalfunctionJan 15, 2024Material 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 5.0MMX220MMX150CM (4F) STERLING BALLOON WAS ADVANCED FOR DILATATION. HOWEVER, UPON FIRST INFLATION AT 5 ATMOSPHERES FOR 3 SECONDS THE BALLOON RUPTURED NEAR THE CENTER IN PINHOLE FORM. 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 18512404 ↗
• MalfunctionJan 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0MMX220MMX150CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 5 ATMOSPHERES FOR 3 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18508868 ↗
• MalfunctionDec 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 5.0MMX220MMX150CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 8 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. 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 GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18351079 ↗
• MalfunctionDec 15, 2023Material 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 5.0MMX220MMX150CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 5 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18335992 ↗
• MalfunctionOct 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURES OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED COMMON ILIAC ARTERY. A 5.0MMX220MMX150CM (4F) STERLING AND AN 8.0 X 40, 75CM MUSTANG BALLOON CATHETERS WERE USED FOR DILATATION. HOWEVER, THE STERLING BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 40 SECONDS WHILE THE MUSTANG BALLOON RUPTURED DURING THE FIRST INFLATION AT 18 ATMOSPHERES FOR 30 SECONDS. THE DEVICES WERE REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17871042 ↗
• MalfunctionAug 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH CHRONIC CRITICAL LIMB ISCHEMIA THREATENING ISCHEMIA (CLTI). THE 100% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 5.0MM X 220MM X 150CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION AND WAS INFLATED TWICE AT 14 ATMOSPHERES. HOWEVER, DURING THE THIRD INFLATION AT 14 ATMOSPHERES, THE BALLOON RUPTURED VERTICALLY. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17498758 ↗
• MalfunctionFeb 22, 2023Material 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 5.0MMX220MMX150CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THIRD INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED VERTICALLY AT THE CENTER OF THE BALLOON. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16417692 ↗
• MalfunctionFeb 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0MM X 220MM X 150CM (4F) FG STERLING MR BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IN THE MIDDLE OF THE FIRST INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED. A STERLING 5.0 MM X 150MM BALLOON CATHETER WAS THEN ADVANCED AS REPLACEMENT. AFTER THAT, AN OPTICROSS IMAGING CATHETER WAS ADVANCED FOR THE INTRAVASCULAR IMAGING OF THE LESION, BUT LOST IMAGE OCCURRED. ANOTHER OF THE SAME OPTICROSS WAS ADVANCED AND LESION CHECK WAS PERFORMED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED, AND NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED AT 6 ATMOSPHERES OR LESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16343912 ↗
• MalfunctionJan 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 5.0MMX220MMX150CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 3 SECONDS, THE BALLOON RUPTURED AT THE CENTER. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT INJURIES REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16242595 ↗
• MalfunctionDec 5, 2022Material 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. A 5.0MMX220MMX150CM STERLING BALLOON WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER OF A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15914766 ↗
• MalfunctionNov 4, 2022Material Rupture; Material 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 5.0MMX220MMX150CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 5 ATMOSPHERES FOR 3 SECONDS, THE BALLOON RUPTURED NEAR THE CENTER OF THE BALLOON. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15738564 ↗
• MalfunctionSep 27, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0MMX220MMX150CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON THE FIRST INFLATION AT 14 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15493878 ↗
• MalfunctionJul 5, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. A 5.0MMX220MMX150CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 12 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14915473 ↗
• MalfunctionJun 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. A 5.0MMX220MMX150CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED AND A PINHOLE WAS NOTED IN THE MIDDLE PART. 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 14622510 ↗
• MalfunctionApr 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0MMX220MMX150CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. 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 14022471 ↗
• MalfunctionMar 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE (PAD). THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0MMX220MMX150CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. 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 13692195 ↗
• MalfunctionFeb 25, 2022Material Rupture; Material Twisted/Bent; Material Rupture; Material Twisted/Bent

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE 95% STENOSED, 6MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. PRE-INFLATION WAS PERFORMED WITH A 3MM BALLOON. AFTER THE NON-BOSTON SCIENTIFIC GUIDEWIRE WAS CROSSED TO THE LESION, A 5.0MMX220MMX150CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS, THE BALLOON TWISTED. THE DEVICE WAS REMOVED. IN AN ATTEMPT TO FIX THE TWISTED BALLOON OUTSIDE OF THE PATIENT, THE GUIDEWIRE WAS ADVANCED IN AND OUT OF THE BALLOON RESULTING IN THE GUIDEWIRE PENETRATING THROUGH THE BALLOON. 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 13599266 ↗
• MalfunctionJan 26, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 5.0MMX220MMX150CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED AND A PINHOLE WAS NOTED IN THE MIDDLE. 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 13358925 ↗