Fortrex™ A35HPV06040080 (UDI 00763000105983)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00763000105983), received between Jul 1, 2020 and Aug 15, 2025 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (18 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryAug 15, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE FORTREX BALLOON, A PATIENT WAS TREATED FOR AN 80% STENOSIS IN THE PROXIMAL LEFT ARM VEIN, WHICH EXHIBITED MODERATE CALCIFICATION AND MODERATE TORTUOSITY. ALLEGATIONS INCLUDED DEFORMATION OF THE CATHETER/DELIVERY SYSTEM, TWISTING AND BUNCHING OF THE DEVICE, AND RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE DEVICE EXHIBITED ISSUES IN FRONT OF THE BALLOON TAIL MARKER POINT. A SURGICAL INCISION WAS REQUIRED TO REMOVE THE BALLOON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22813817 ↗
• MalfunctionJul 23, 2025Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE FORTREX BALLOON ALONG WITH A NON-MEDTRONIC SHEATH DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S LEFT DISTAL CEPHALIC VEIN. MODERATE CALCIFICATION AND LITTLE TORTUOSITY WERE REPORTED. ARTERY DIAMETER REPORTED AS 3MM AND LESION DIAMETER REPORTED AS 4MM. DEVICE WAS PREPPED WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT A LONGITUDINAL BALLOON BURST OCCURRED AT 18ATM DURING INFLATION. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE RUPTURED BALLOON WAS REMOVED AND ANOTHER BALLOON WAS USED TO DILATE AND COMPLETED THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22573894 ↗
• InjuryJul 4, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE FORTREX BALLOON DILATATION CATHETER AT THE DISTAL LEFT ARTERIOVENOUS FISTULA ANASTOMOSIS BETWEEN THE ARTERY AND CEPHALIC VEIN, A 60% SOFT TISSUE LESION STENOSIS WAS PRESENT. DURING BALLOON INFLATION WITH AN INFLATION DEVICE AT 23 ATM, A PIN HOLE RUPTURE OF THE BALLOON OCCURRED, RESULTING IN A BALLOON BURST. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. SUBSEQUENTLY, AN ARTERIOVENOUS ENDOLEAK AND FISTULA ARTERIOVENOUS VESSEL RUPTURE OCCURRED, WHICH WAS ADDRESSED BY PERFORMING A VASCULAR ANASTOMOSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Perforation of Vessels

  MAUDE report 22402406 ↗
• MalfunctionJun 19, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE FORTREX BALLOON, THERE WAS ABNORMAL PRESSURE OBSERVED WITH THE BALLOON, FOLLOWED BY A LONGITUDINAL RUPTURE DURING INFLATION AT 12 ATM. THE BALLOON WAS INFLATED USING AN INFLATION DEVICE, AND ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE PROCEDURE WAS COMPLETED BY USING A NEW BALLOON. NO PATIENT SYMPTOMS, COMPLICATIONS, OR ADVERSE OUTCOMES WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289062 ↗
• MalfunctionMar 12, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A FORTREX HIGH PRESSURE BALLOON DILATATION DEVICE FOR TREATMENT IN THE LEFT MID POPLITEAL ARTERY OF A PATIENT. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. DEVICE WAS PREPPED AS PER IFU. IT WAS REPORTED THAT A BALLOON PIN HOLE BURST OCCURRED DURING BALLOON INFLATION. IT WAS REPORTED THAT THIS OCCURRED AT 20ATMS. THE BALLOON WAS REPLACED. NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21582300 ↗
• MalfunctionJan 15, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A FORTREX HIGH PRESSURE BALLOON DILATATION DEVICE FOR TREATMENT IN A PATIENT WITH CALCIFICATION. THE DEVICE WAS NOT PREPPED AS PER IFU. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. IT WAS REPORTED THAT A CIRCUMFERENTIAL/RADIAL BALLOON BURST OCCURRED DURING BALLOON INFLATION AT 20 ATM, THE DEVICE WAS REPLACED AND NO PATIENT INJURY REPORTED FOR THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21159815 ↗
• MalfunctionJan 6, 2025Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE A FORTREX HP PTA BALLOON CATHETER DURING PATIENT TREATMENT. A BALLOON BURST WAS REPORTED. FIRST INFLATION USED 24 ATMOSPHERES, THE SECOND INFLATION USED 20 ATMOSPHERES AND BALLOON RUPTURED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21077435 ↗
• MalfunctionNov 21, 2024Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE A FORTREX HP PTA BALLOON CATHETER DURING TREATMENT OF ARTERIOVENOUS FISTULA STENOSIS IN A PATIENT. IT WAS REPORTED THAT DURING THE BALLOON DILATATION, WHEN THE PRESSURE WAS INCREASED TO 18ATM FOR THE SECOND TIME, THE BALLOON SUDDENLY RUPTURED. A REPLACEMENT BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20744474 ↗
• MalfunctionNov 16, 2024Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  PHYSICIAN ATTEMPTED TO USE A FORTREX HP PTA BALLOON CATHETER DURING TREATMENT OF THE PATIENT'S DISTAL RENAL ARTERY. THERE WERE NO ABN ORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU (INSTRUCTION FOR USE) WITH NO ISSUES IDENTIFIED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE FIRST INFLATION PRESSURE WAS ABOUT 12ATMS, AND THE BALLOON FAILED TOO FULLY OPEN. THE PATIENT WAS IN UNBEARABLE PAIN AND IT WAS DEFLATED. FOR THE SECOND INFLATION, PRESSURE WAS INCREASED TO 16 ATMS BUT PHYSICIAN SUDDENLY FELT DEFLATION. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) SHOWED EXTRAVASATION OF CONTRAST AGENT, AND HEMATOMA WAS SEEN AT THE INFLATION SITE. AFTER THE BALLOON WAS SLOWLY PULLED OUT, IT WAS FOUND TO BE RUPTURED. A LONGITUDINAL BALLOON BURST WAS REPORTED DURING BALLOON INFLATION AT 16ATMS. A REPLACEMENT BALLOON WAS USED TO COMPRESS AND STOP BLEEDING AND THEN INFLATE AGAIN TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: Hematoma; Pain

  MAUDE report 20701272 ↗
• MalfunctionOct 16, 2024Leak/Splash; Leak/Splash

  PHYSICIAN ATTEMPTED TO USE A FORTREX HP PTA BALLOON CATHETER DURING BALLOON DILATATION SURGERY. IT WAS REPORTED THAT THE BALLOON TUBE WAS FOUND TO BE LEAKING WATER WHEN WATER WAS INJECTED. PHYSICIAN FOLDED THE TUBE AND IT COULD CONTINUE TO BE USED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20459238 ↗
• MalfunctionAug 14, 2024Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  A PHYSICIAN WAS USING A FORTREX BALLOON FOR TREATMENT OF A FIBROUS LESION WITH 40% STENOSIS IN THE MID RIGHT REGION OF THE VESSEL. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED AT 20ATM A PINHOLE OCCURRED. THE PINHOLE WAS NOT NOTED PRIOR TO INSERTION INTO THE PATIENT. THE BALLOON WAS NOT RUPTURED, AND THE NEEDLE HOLE CAUSED THE BALLOON TO LEAK AND COULD NOT BE USED NORMALLY. ALL FRAGMENTS WERE RETRIEVED. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE. THE BALLOON WAS REPLACED TO COMPLETE THE CASE. NO PATIENT INJURY REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19979777 ↗
• MalfunctionAug 12, 2024Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE A FORTREX HP PTA BALLOON CATHETER DURING TREATMENT OF THE PATIENTS LEFT MID PERIPHERAL ARTERIOVENOUS FISTULA LESIONS. ARTERY DIAMETER REPORTED AS 6MM. LESION LENGTH REPORTED AS 4MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU (INSTRUCTION FOR USE) WITH NO ISSUES IDENTIFIED. EMBOLIC PROTECTION WAS NOT USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. A PIN HOLE BALLOON BURST WAS REPORTED DURING BALLOON INFLATION AT 20ATMS. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. A REPLACEMENT BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19959076 ↗
• MalfunctionAug 6, 2024Leak/Splash; Leak/Splash

  PHYSICIAN ATTEMPTED TO USE A FORTREX HP BALLOON PRIOR TO PATIENT TREATMENT. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PR EPARATION, PROCEDURE, POST-PROCEDURE WITH AN ISSUE NOTED. 50/50 CONTRAST INFLATION FLUID WAS USED. IT WAS REPORTED A LEAK WAS NOTED DURING PREPARATION. THIS ISSUE IS REPORTED FOR 3 BALLOONS. A REPLACEMENT MEDTRONIC DEVICE WAS USED TO COMPLETE PROCEDURE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19919653 ↗
• MalfunctionJun 7, 2024Burst Container or Vessel; Burst Container or Vessel

  IT IS REPORTED THAT A PHYSICIAN USED A FORTREX BALLOON DURING A PROCEDURE. AFTER BRACHIAL PLEXUS BLOCK ANESTHESIA WAS ADMINISTERED, THE PHYSICIAN PUNCTURED THE FISTULA VEIN ALONG THE BLOOD FLOW FROM THE FOREARM CEPHALIC VEIN UNDER THE GUIDANCE OF INTRACAVITARY ULTRASOUND. AFTER THE BLOOD RETURNED, THE MICRO-PUNCTURE SHEATH WAS QUICKLY EXCHANGED, AND THEN A 0.035 GUIDEWIRE WAS INSERTED. UNDER ULTRASOUND GUIDANCE, THE VASCULAR OCCLUSION WAS SUCCESSFULLY PASSED (CUBITAL FISTULA VEIN), CONTINUED THROUGH THE OCCLUSION INTO THE BASILIC VEIN UNTIL THE AXILLARY VEIN. THE PHYSICIAN INSERTED THE FORTREX BALLOON CATHETER ALONG THE GUIDEWIRE AND THE BALLOON COULDBE SEEN UNDER ULTRASOUND TO REACH THE OCCLUSION. THE BALLOON WAS PRE-DILATED AT 12-24ATM, AND THE BALLOON CATHETER RUPTURED LONGITUDINALLY WHEN THE PRESSURE INCREASED TO 24ATM. THE PATIENT'S INTERNAL FISTULA HAD MULTIPLE STENOSES, AND THE BALLOON WAS REPEATEDLY DILATED, AND OPENED AND CONTRACTED MANY TIMES, WHICH COULD EASILY CAUSE THE BALLOON TO RUPTURE. THE PHYSICIAN IMMEDIATELY STOPPED USING IT AND REPLACED IT WITH A NEW BALLOON DILATION CATHETER TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483434 ↗
• MalfunctionMar 21, 2024Burst Container or Vessel; Burst Container or Vessel

  A PHYSICIAN WAS ATTEMPTING TO USE A FORTEX BALLOON FOR TREATMENT OF ARTERIOVENOUS FISTULA STENOSIS. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED ON THE FIRST INFLATION THE BALLOON BURST LONGITUDINALLY AT 16 ATM. ALL FRAGMENTS WERE RETRIEVED. THE BALLOON WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18948215 ↗
• MalfunctionAug 8, 2023Burst Container or Vessel; Burst Container or Vessel

  A PHYSICIAN WAS USING A FORTEX BALLOON FOR THE TREATMENT OF AN 80MM FIBROUS LESION WITH CHRONIC TOTAL OCCLUSION IN THE LEFT FOREARM ARTERIOVENOUS FISTULA. A NON MEDTRONIC INFLATION DEVICE WAS USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. IT WAS REPORTED THAT A LONGITUDINAL BURST OCCURRED AT 20 ATM. ALL FRAGMENTS WERE RETRIEVED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. ANOTHER BALLOON WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17479422 ↗
• MalfunctionOct 3, 2022Burst Container or Vessel; Burst Container or Vessel

  A FORTREX PTA BALLOON CATHETER WAS INTENDED TO BE USED DURING TREATMENT OF A 60MM CALCIFIED LESION WITH 45% STENOSIS IN THE RIGHT PROXIMAL REGION OF THE SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS 6MM IN DIAMETER WITH MODERATE TORTUOSITY AND SEVERE CALCIFICATION. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE BALLOON WAS INFLATED USING SALINE FLUID AND AN INFLATION DEVICE. IT WAS REPORTED DURING BALLOON INFLATION THE A LONGITUDINAL BURST OCCURRED AT 7 ATM. THE BALLOON BURST ON THE FIRST INFLATION. NO RESISTANCE WAS EXPERIENCED AND THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE PROCEDURE WAS COMPLETED WITH ADDITIONAL PTA BALLOONS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15527990 ↗
• InjuryFeb 7, 2022Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE A FORTREX PTA BALLOON DURING PROCEDURE TO TREAT A LITTLE CALCIFIED FIBROUS LESION IN THE MID AV FISTULA WITH 80% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS. NO EMBOLIC PROTECTION WAS USED. A MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. IT WAS NOT SPECIFIED IF IFU WAS FOLLOWED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DURING FIRST BALLOON INFLATION A LONGITUDINAL BURST OCCURRED AT 20ATM. NOT ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. PHYSICIAN USED A NON-MEDTRONIC STENT TO PIN DOWN REMAINING BALLOON MATERIAL. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. A 10X80 NON-MEDTRONIC STENT WAS DEPLOYED WITH NO ISSUE AND PROCEDURE WAS COMPLETED. THERE WAS NO VESSEL INJURY REPORTED. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13468983 ↗
• MalfunctionNov 7, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN USED A FORTREX HP PTA BALLOON WITH A 6FR NON-MEDTRONIC VASCULAR SHEATH AND 0.035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A FIBROUS LESION IN THE PATIENT'S RIGHT SHORT SAPHENOUS VEIN (SSV). SLIGHT VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. A NON-MEDTRONIC INFLATION DEVICE WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. A LONGITUDINAL BALLOON BURST IS REPORTED WHEN THE DEVICE WAS INFLATED TO 18 ATM. ALL BALLOON FRAGMENTS WERE RETRIEVED. THE RUPTURED BALLOON WAS PUSHED OUT THE BLOOD VESSEL AND A NEW BALLOON WAS USED TO CONTINUE TO PRESSURIZE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12758099 ↗
• MalfunctionOct 27, 2021Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  PHYSICIAN WAS ATTEMPTING TO USE FORTREX PTA BALLOON CATHETER ALONG WITH NON-MEDTRONIC 6FR SHEATH AND 0.035" GUIDEWIRE DURING PROCEDURE TO TREAT THE RIGHT ARM AUTOGENOUS ARTERIOVENOUS FISTULA VEIN STENOSIS. LESION STENOSIS ABOUT 80%. IFU WAS FOLLOWED A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR THE INFLATION OF THE BALLOON. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU. IT WAS REPORTED THAT BALLOON INFLATION DIFFICULTIES OCCURRED AT 15ATM. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. AFTER THE BALLOON WAS PUT INTO THE PATIENT'S BLOOD VESSEL, THE STENOSIS BALLOON WAS PRESSURIZED TO 15ATM AND THE BALLOON RUPTURED. RUPTURE OCCURRED ON FIRST INFLATION. PINHOLE BURST OCCURRED. THE BALLOON DID NOT FRAGMENT. ALL OF THE BALLOON REMOVED. NO VESSEL INJURY NOTED. DEVICE WAS SAFELY REMOVED FROM PATIENT. NO INTERVENTION REQUIRED FOR REMOVAL. AFTER THAT, A NEW BALLOON WAS REPLACED WITH, AND THE LESION WAS EXPANDED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12702997 ↗
• MalfunctionSep 8, 2021Leak/Splash; Leak/Splash

  PHYSICIAN WAS ATTEMPTING TO USE A FORTREX PTA BALLOON DURING PROCEDURE. IT WAS REPORTED THAT THE BALLOON ENTERED THE STENOTIC LESION THROUGH THE GUIDE WIRE. THE FIRST TIME THE PRESSURE PUMP WAS USED TO PRESSURIZE, THE PRESSURE COULD NOT BE PRESSURIZED, AND THE PRESSURE LEAKED. AFTER THE BALLOON WAS PULLED OUT, IT WAS FOUND THAT THE BALLOON LEAKED AFTER BEING PRESSURIZED. THE INSERTION SITE WAS TREATED WITH IODOPHOR FOR SKIN DISINFECTION PRIOR TO PRODUCT PLACEMENT. THE LEAK WAS NOTED AT THE CONNECTION BETWEEN THE BALLOON AND THE SHAFT. THERE WAS A SMALL WATER COLUMN FLOWING OUT OF THE LEAK. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. PHYSICIAN REPLACED WITH MEDTRONIC BALLOON OF THE SAME MODEL AND COMPLETED THE OPERATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12437761 ↗
• MalfunctionSep 8, 2021Leak/Splash; Leak/Splash

  PHYSICIAN WAS ATTEMPTING TO USE A FORTREX PTA BALLOON CATHETER DURING PROCEDURE TO TREAT THE CEPHALIC VEIN IN THE RIGHT ARM. IT WAS REPORTED THAT THE BALLOON LUMEN LEAKED, AND THE PRESSURIZED SALINE WOULD FLOW OUT THROUGH THE GUIDE WIRE LUMEN. AFTER THE BALLOON WAS DELIVERED INTO THE STENOSIS OF THE BLOOD VESSEL THROUGH THE GUIDE WIRE, THE PRESSURE OF THE BALLOON COULD NOT BE ADDED AFTER IT WAS CONNECTED TO THE PRESSURE PUMP. AFTER THE BALLOON WAS PULLED OUT AND TESTED IN VITRO, IT WAS FOUND THAT THE BALLOON LUMEN LEAKED, AND THE PRESSURIZED SALINE WOULD FLOW OUT THROUGH THE GUIDE WIRE LUMEN. THERE WAS VESSEL STENOSIS AT THE PUNCTURE SITE. THERE WAS NO RESISTANCE WHEN THE BALLOON WAS FED INTO THE STENOSIS THROUGH THE GUIDEWIRE. DEVICE WAS SAFELY REMOVED FROM PATIENT. PHYSICIAN REPLACED WITH A SET OF BALLOON OF THE SAME SPECIFICATION, OPENED UP THE LESION, AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12437733 ↗
• MalfunctionJul 1, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE A FORTREX PTA BALLOON ALONG WITH NON-MEDTRONIC 7FR SHEATH AND 0.035" GUIDE WIRE DURING PROCEDURE TO TREAT A NONE CALCIFIED FIBROUS LESION IN THE LEFT PROXIMAL RADIO CEPAHLIC ARTERY WITH 75% STENOSIS. THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 40MM RESPECTIVELY. A MEDTRONIC INFLATION DEVICE WAS USED TO INFLATE THE BALLOON. THERE WAS NO DAMAGE TO DEVICE PACKAGING. THERE WAS NO ISSUE NOTED WHILE REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. DURING SECOND INFLATION A LONGITUDINAL BURST OCCURRED AT 22ATM ALL BALLOON FRAGMENTS WERE RETRIEVED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY IMPLANTED STENT. THERE WAS NO RESISTANCE WHILE ADVANCING DEVICE. ANOTHER MEDTRONIC BALLOON SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10218812 ↗