Symmetry™ M001103240Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 08714729181736), received between Aug 24, 2018 and Oct 22, 2024 — classified as 6 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (31 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A VESSEL. A 3.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION AT BELOW NOMINAL PRESSURE, THE BALLOON RUPTURED. 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 20508510 ↗
• InjuryOct 17, 2024Break; Difficult to Remove; Material Rupture; Break; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND CATHETER SEPARATION OCCURRED WHICH REQUIRES ADDITIONAL INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RADIAL ARTERY. A 3.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE NON-BOSTON SCIENTIFIC SHEATH WAS PLACED IN THE VEIN. HOWEVER, UPON INFLATION AT 17 ATMOSPHERES BEYOND ANASTOMOSIS, THE BALLOON RUPTURED, AND THE BALLOON PART GOT SEPARATED INSIDE THE CATHETER. UPON REMOVAL, RESISTANCE WAS FELT AND THE DEVICE GOT CAUGHT ON THE SHEATH. CONSEQUENTLY, THE DEVICE WAS REMOVED SURGICALLY AS A SINGLE UNIT WITH THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471209 ↗
• MalfunctionOct 16, 2024Inflation Problem; Inflation Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 1 OCT 2024. IT WAS REPORTED THAT BALLOON PINHOLE AT THE DISTAL MARKERBAND OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS VESSEL. A 3.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, INITIAL INFLATION PRESSURE DIDN'T CHANGE. THE DEFLATOR INDICATED THE BALLOON CAUSED THE ISSUE. INSTEAD OF RUPTURING, PRESSURE LEAKAGE SEEMS TO BE THE PROBLEM. 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. HOWEVER, PRODUCT ANALYSIS REVEALED PINHOLE LOCATED APPROXIMATELY AT THE DISTAL MARKERBAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20465380 ↗
• MalfunctionSep 10, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED CEPHALIC VEIN OF THE FOREARM. A 3.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED IN A VERTICAL FORM UPON THIRD INFLATION AT 15 ATMOSPHERES FOR 30 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 20186384 ↗
• InjuryAug 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED AND WAS REMOVED VIA SNARING. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED FOREARM CEPHALIC VEIN ANASTOMOSIS PART. A 3.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING 4TH INFLATION FOR 30 SECONDS, THE BALLOON RUPTURED. THE BALLOON COULD NOT BE PULLED INTO THE SHEATH SINCE NEGATIVE PRESSURE WAS NOT APPLIED. THEREFORE, A SHEATH WAS ADDED UPWARD, AND THE DEVICE WAS RETRIEVED BY GRASPING IT WITH A 5MM SNARE CATHETER. THE PROCEDURE WAS COMPLETED USING 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 20022296 ↗
• MalfunctionAug 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WERE ALL ANASTOMOTIC LESIONS IN THE SAME PATIENT LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED FOREARM LOOP SHUNT. A TOTAL OF FOUR SYMMETRY BALLOON CATHETERS WERE USED IN THIS PROCEDURE WITH TWO IN THE SIZES 3.5-4/4T/90 AND TWO 3.0-4/4T/90. AS THE 3.5-40 DID NOT WIDEN, THEY WERE CHANGED TO 3.0-40 AND AN ATTEMPT WAS MADE TO INCREASE THE PRESSURE, BUT IT ALSO DID NOT WIDEN. DURING THE PROCEDURE, THE BALLOONS RUPTURED STARTING WITH THE FIRST DEVICE ON THE SECOND INFLATION AT 10 ATMOSPHERES, THE SECOND DEVICE ON THE FIRST INFLATION AT 10 ATMOSPHERES, THE THIRD DEVICE ON THE FIRST INFLATION AT 8 ATMOSPHERES, AND THE FOURTH DEVICE ON THE FIRST INFLATION AT 10 ATMOSPHERES. ALL FOUR BALLOONS WERE INFLATED FOR 30 SECONDS BEFORE THEY BURST. THE DEVICES WERE SUCCESSFULLY REMOVED WITH THE RUPTURES NOTED TO BE VERTICALLY SEPARATED IN SHAPE BEFORE THEY WERE REPLACED FOR ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19977355 ↗
• MalfunctionAug 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WERE ALL ANASTOMOTIC LESIONS IN THE SAME PATIENT LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED FOREARM LOOP SHUNT. A TOTAL OF FOUR SYMMETRY BALLOON CATHETERS WERE USED IN THIS PROCEDURE WITH TWO IN THE SIZES 3.5-4/4T/90 AND TWO 3.0-4/4T/90. AS THE 3.5-40 DID NOT WIDEN, THEY WERE CHANGED TO 3.0-40 AND AN ATTEMPT WAS MADE TO INCREASE THE PRESSURE, BUT IT ALSO DID NOT WIDEN. DURING THE PROCEDURE, THE BALLOONS RUPTURED STARTING WITH THE FIRST DEVICE ON THE SECOND INFLATION AT 10 ATMOSPHERES, THE SECOND DEVICE ON THE FIRST INFLATION AT 10 ATMOSPHERES, THE THIRD DEVICE ON THE FIRST INFLATION AT 8 ATMOSPHERES, AND THE FOURTH DEVICE ON THE FIRST INFLATION AT 10 ATMOSPHERES. ALL FOUR BALLOONS WERE INFLATED FOR 30 SECONDS BEFORE THEY BURST. THE DEVICES WERE SUCCESSFULLY REMOVED WITH THE RUPTURES NOTED TO BE VERTICALLY SEPARATED IN SHAPE BEFORE THEY WERE REPLACED FOR ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19977336 ↗
• MalfunctionAug 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED FOREARM ARTERY ANASTOMOSIS. AN SV/3.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON VERTICALLY RUPTURED UPON THIRD INFLATION AT 15 ATMOSPHERES FOR 1 MINUTE. THE DEVICE WAS PULLED OUT WITHOUT ANY PROBLEMS. SUBSEQUENTLY, ANOTHER OF THE SAME SYMMETRY BALLOON WAS ADVANCED, HOWEVER, THE BALLOON ALSO RUPTURED DURING SECOND INFLATION AT 12 ATMOSPHERES FOR 1 MINUTE. UPON REMOVAL, THE DEVICE COULD NOT BE REMOVED FROM THE 6F NON-BOSTON SCIENTIFIC SHEATH. IT WAS SEPARATED WHEN PULLED OUT, AND THE BALLOON TIP WAS RETRIEVED USING A SNARE. THE PROCEDURE WAS COMPLETED WITH THIS 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 19913794 ↗
• InjuryAug 5, 2024Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED FOREARM ARTERY ANASTOMOSIS. AN SV/3.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON VERTICALLY RUPTURED UPON THIRD INFLATION AT 15 ATMOSPHERES FOR 1 MINUTE. THE DEVICE WAS PULLED OUT WITHOUT ANY PROBLEMS. SUBSEQUENTLY, ANOTHER OF THE SAME SYMMETRY BALLOON WAS ADVANCED, HOWEVER, THE BALLOON ALSO RUPTURED DURING SECOND INFLATION AT 12 ATMOSPHERES FOR 1 MINUTE. UPON REMOVAL, THE DEVICE COULD NOT BE REMOVED FROM THE 6F NON-BOSTON SCIENTIFIC SHEATH. IT WAS SEPARATED WHEN PULLED OUT, AND THE BALLOON TIP WAS RETRIEVED USING A SNARE. THE PROCEDURE WAS COMPLETED WITH THIS 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 19911316 ↗
• MalfunctionApr 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED ON THE MODERATELY TORTUOUS AND MILDLY CALCIFIED FOREARM CEPHALIC VEIN. A 3.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING PROCEDURE, THE BALLOON RUPTURED ON THE FIRST INFLATION AT 15 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND IT WAS NOTED THAT THE RUPTURE WAS VERTICALLY SEPARATED. THE DEVICE WAS REPLACED FOR ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19055827 ↗
• InjuryJun 6, 2023Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE AND TIP DETACHMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RETROGRADE APPROACH FROM THE RADIAL VEIN SIDE. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS FOREARM RADIAL ARTERY. AFTER A 5FR 4CM NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER WAS PLACED AND A NON-BSC GUIDEWIRE WAS CROSSED THE LESION, PRE-DILATION WAS PERFORMED WITH A 3.5-4/4T/90 SYMMETRY BALLOON CATHETER. HOWEVER, ON THE THIRD INFLATION AT 16 ATMOSPHERES, THE BALLOON RUPTURED. THE BALLOON AND WIRE WERE REMOVED TOGETHER FROM THE SHEATH, BUT THE TIP OF THE BALLOON WAS NOTED TO BE MISSING. SUBSEQUENTLY, ANGIOGRAPHY WAS PERFORMED, BUT THE LOCATION OF THE SEPARATED PART COULD NOT BE CONFIRMED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17073952 ↗
• InjuryMay 9, 2023Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE AND DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED SHUNT LIMB. A 3.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INITIAL INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED IMMEDIATELY. A RUPTURE WAS IDENTIFIED, AND DEFLATION WAS PERFORMED SEVERAL TIMES. DURING REMOVAL, THE BALLOON WAS STUCK ON THE TIP OF THE SHEATH AND COULD NOT BE REMOVED PROPERLY. AN ATTEMPT WAS MADE TO REMOVE THE BALLOON WHILE ROTATING IT, BUT ONLY THE BALLOON CATHETER WAS REMOVED WHILE BEING LIFTED AND BALLOON PART WAS REMAINED INSIDE THE BODY. A BIOPSY FORCEPS WAS THEN INSERTED, AND THE BALLOON REMNANT WAS COLLECTED. ECHOCARDIOGRAPHY CONFIRMED THAT THERE WAS NO RETENTION IN THE BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16899059 ↗
• MalfunctionFeb 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED CEPHALIC VEIN. A 3.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. INFLATION WAS PERFORMED FOURTH TIMES. HOWEVER, DURING FOURTH INFLATION AT 18 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED VERTICALLY. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16344097 ↗
• MalfunctionJan 26, 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 CEPHALIC VEIN. A 3.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16246246 ↗
• MalfunctionDec 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED FOREARM CEPHALIC VEIN. A 3.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 15 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED VERTICALLY. 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 POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15973540 ↗
• MalfunctionNov 21, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED FOREARM RADIAL CUTANEOUS VEIN. A 3.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, ON THE SECOND INFLATION AT 18 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15835070 ↗
• MalfunctionNov 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED FOREARM CEPHALIC VEIN. A 3.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 18 ATMOSPHERES FOR 30 SECONDS THE BALLOON RUPTURED. 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 15738391 ↗
• MalfunctionSep 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED FOREARM CEPHALIC VEIN. A 3.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED IN A VERTICAL TEAR. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15465604 ↗
• MalfunctionSep 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. (B)(4). A 3.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 15 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND IT WAS OBSERVED THAT THE BALLOON WAS COMPLETELY VERTICALLY SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414635 ↗
• MalfunctionJul 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE NON-TORTUOUS AND MODERATELY CALCIFIED BRACHIAL VEIN. A 3.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 18 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15040106 ↗
• MalfunctionJul 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE NON-CALCIFIED NEAR THE FOREARM VEIN ANASTOMOSIS A 3.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 18 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED WITH OVERALL VERTICAL SPLIT. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT INJURY REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15037074 ↗
• MalfunctionMar 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED NEAR A SHUNT ANASTOMOSIS IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 3.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 12 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED AND A VERTICAL TEAR WAS NOTED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13634619 ↗
• MalfunctionJun 30, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 3.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED AND A VERTICAL CRACK AT THE TIP OF THE BALLOON WAS NOTED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED VESSEL WITH 85% STENOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12096067 ↗
• MalfunctionJan 21, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A SV/3.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 15 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9611135 ↗
• MalfunctionDec 4, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15NOV2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED AND SHAFT KINK OCCURRED. THE TARGET LESION WAS 90% STENOSED AND LOCATE IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS VESSEL. A 3.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PHYSICIAN PUSHED THE DEVICE BUT THE CATHETER GOT KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9412405 ↗