POWERFLEX 4400804SRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 20705032059814), received between Jul 28, 2017 and Nov 20, 2023 — classified as 1 injury, 24 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF AN 8MM X 4CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING A POST-DILATION INFLATION. AS A RESULT, AN 8MM X 4CM NON-CORDIS BALLOON CATHETER WAS USED AS A REPLACEMENT TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS UNAVAILABLE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18169206 ↗
• MalfunctionApr 3, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE POWERFLEX PRO 8MM X 4CM BALLOON RUPTURED DURING USE AND THE CONTRAST AGENT LEAKED. THE BALLOON RUPTURED AT 16 ATM. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT. THE CASE WAS COMPLETED WITH A NEW POWERFLEX PRO BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE PATIENT HAD A LOWER EXTREMITY ATHEROSCLEROSIS. THE LESION WAS CALCIFIED WITH AN 80% STENOSIS. THE VESSEL WAS NOTED TO HAVE A LITTLE TORTUOSITY. THE DEVICE WAS NOT USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND WHILE INSERTING THROUGH THE GUIDE CATHETER. THERE WAS DIFFICULTY ADVANCING THE DEVICE THROUGH THE VESSEL; HOWEVER, THERE WAS NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND AND W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16665778 ↗
• MalfunctionMar 14, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF AN 8MM X 4CM X 80 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNKNOWN DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY. THERE WAS SEVERE CALCIFICATION. THIS WAS AN ENDOVASCULAR THROMBECTOMY (EVT) CASE. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER OR REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE ISSUE WAS NOTED INSIDE THE PATIENT. A CONTRALATERAL APPROACH WAS USED. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE USER WAS TRAINED IN USE OF DEVICE. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, AS IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539080 ↗
• InjuryApr 18, 2022Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, THE POWERFLEX PRO 8MM 4CM 80 BURST WHILE INFLATING THE DRAINING VESSEL OF A SHUNT, AND HALF OF THE BALLOON REMAINED IN THE PATIENT DURING WITHDRAWAL OF THE DEVICE. THE BALLOON HAD TORN RIGHT THROUGH. THE PART WAS REMOVED FROM THE PATIENT. AN EXTRA INTERVENTION HAD TO BE DONE TO REMOVE THE PART OF THE BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14135368 ↗
• MalfunctionFeb 17, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A POWERFLEXPRO 8MM4CM 80 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATION CATHETER RUPTURED AT 4ATM IN AN ENDOVASCULAR ANEURYSM REPAIR PROCEDURE. THE DEVICE WAS REPLACED WITH AN UNKNOWN BALLOON CATHETER TO COMPLETE THE PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE IFU. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, OR REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE PREPPED NORMALLY AND MAINTAINED A NEGATIVE PRESSURE. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT NOT PROVIDED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED DUE TO SUSPICION OF INFECTIOUS DISEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13551596 ↗
• MalfunctionNov 18, 2021Burst Container or Vessel; Burst Container or Vessel

  DURING AN INTERVENTIONAL PROCEDURE, AN 8MM X 4CM POWER FLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 8 ATMOSPHERES (ATM). THEREFORE, THE DEVICE WAS REPLACED WITH A NEW 8MM X 2CM POWER FLEX PRO PTA BALLOON AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE ACCESS SITE WAS THE FEMORAL. THERE WAS NO DIFFICULTY REMOVING THE COMPLAINT BALLOON FROM THE PACKAGING. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. IT WAS EASILY REMOVED. PATIENT INFORMATION INCLUDING THE REASON FOR THE PROCEDURE AND MEDICAL HISTORY WERE REQUESTED BUT WERE NOT AVAILABLE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED DUE TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12840629 ↗
• MalfunctionSep 27, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AN 8MM X 4CM 80 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED; HOWEVER, IT RUPTURED. THERE WAS DIFFICULTY CROSSING THE LESION. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS FOR AN ENDOVASCULAR THERAPY (EVT) CASE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS NOR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED NORMALLY (I.E., MAINTAIN NEGATIVE PRESSURE). THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE, OR THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THE CATHETER WAS IN AN ACUTE BEND. THE PLUNGER DEPRESSED INTO THE SYRINGE/INDEFLATOR WHEN TRYING TO INFLATE. LEAKAGE WAS NOTED FROM EITHER THE BALLOON, SHAFT, HUB, OR OTHER UNKNOWN SEGMENT. THE BALLOON CATHETER WAS NOT KINKED WHILE BEING USED. THE BALLOON CATHETER WAS REMOVED EASILY. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. A NEW DEVICE WAS USE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12531641 ↗
• MalfunctionMay 17, 2021Structural Problem; Structural Problem

  AS REPORTED, THE DOCTOR FELT THAT THE MARKER WAS SHORTER THAN THE BALLOON LENGTH (4 CM) SHOWN IN THE SIZE OF THE 8MM X 4CM X 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC). S/HE MEASURED IT WHILE IN THE PATIENT, WHEN IT WAS INFLATED POST DILATION. THE DISTANCE BETWEEN THE MARKERS WAS AS SHORT AS 3.5 CM. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED FOR POST-DILATION AFTER THE STENT (UNKNOWN) WAS IMPLANTED. THE DEVICE WAS OPENED IN THE STERILE FIELD. THE DEVICE WAS STORED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THE INTENDED PROCEDURE WAS A PTA OF THE ILIAC ARTERY. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, OR REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE STERILE PACKAGING WAS NOT COMPROMISED. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, OR NOT APPLICABLE. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11831301 ↗
• MalfunctionMay 3, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, 8MM X 4CM X 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED, HOWEVER, IT RUPTURED AT 4 ATMOSPHERES (ATM). THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11759205 ↗
• MalfunctionApr 12, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 8MM X 4CM X 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS USED, BUT IT RUPTURED WITHIN ITS NOMINAL PRESSURE. IT WAS REPLACED WITH ANOTHER BALLOON CATHETER (UNKNOWN) AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE COMMON ILIAC ARTERY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648209 ↗
• MalfunctionJan 4, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF THE 8MM X 4CM X 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) RUPTURED IN THE VESSEL BEFORE REACHING NOMINAL PRESSURE. IT WAS ALSO NOTED THAT THE DEVICE WAS USED BEYOND THE EXPIRATION DATE. THE BALLOON WAS REMOVED FROM THE PATIENT¿S BODY AND A NEW BALLOON (UNKNOWN) WAS INSERTED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED PER LABELLING AND OPENED IN STERILE FIELD. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS THROWN AWAY.

  Patient problems: Insufficient Information

  MAUDE report 11109081 ↗
• MalfunctionOct 5, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING SECOND INFLATION; THE PHYSICIAN TRIED TO INFLATE AN 8MM X 4CM X 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER AT 12 ATMOSPHERES (ATM) FOR 20 SECONDS. HOWEVER, IT RUPTURED WHEN IT WAS INFLATED APPROXIMATELY 15 SECONDS. AN INTRAVENOUS ULTRASOUND (IVUS) ,AND CONTRAST SHOWED THAT THE LESION WAS INFLATED ENOUGH, THEREFORE, THE PROCEDURE WAS COMPLETED AS IT WAS WITHOUT ADDING INFLATION. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE RIGHT COMMON ILIAC ARTERY. AN APPROACH WAS MADE FROM THE RIGHT COMMON FEMORAL ARTERY. THE DEVICE WAS INTENDED TO BE USED FOR POST-DILATION. THE PHYSICIAN INFLATION INFLATED IT AT 8 ATM FOR 20 SECONDS AS THE FIRST INFLATION. AFTER THAT, SINCE THE INFLATION WAS NOT ENOUGH, SECOND INFLATION WAS PERFORMED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION DUE TO HOSPITAL REGULATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10627762 ↗
• MalfunctionAug 21, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 8MM X 4CM 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INFLATED AS POST DILATION AFTER A SMART STENT WAS IMPLANTED AT THE RIGHT EXTERNAL ILIAC ARTERY; HOWEVER, IT RUPTURED OVER ITS NOMINAL PRESSURE AND IT COULD NOT BE INFLATED. THE DOCTOR CONFIRMED THAT THERE WAS A BLOOD AND THE DEVICE WAS RUPTURED AFTER IT WAS BEING PULLED OUT FROM THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETED AS IT WAS. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, BALLOON COVER THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED NORMALLY. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10437704 ↗
• MalfunctionAug 18, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AN 8MM X 4CM X 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED BUT IT RUPTURED AT 10 ATMOSPHERES (ATM) DURING ITS INITIAL INFLATION AND WAS REMOVED INTACT FROM THE PATIENT. THEREFORE, IT WAS REPLACED WITH ANOTHER UNKNOWN DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A PERCUTANEOUS PERIPHERAL INTERVENTION (PPI) CASE. THE TARGET LESION WAS THE ILIAC ARTERY. THE PHYSICIAN WAS TRAINED WITH THE DEVICE. THE DEVICE WAS OPENED IN A STERILE FIELD. THE PRODUCT LOOKED NORMAL WHEN IT WAS REMOVED FROM IT'S PACKAGING. THE DEVICE PREPPED NORMALLY. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, PROTECTIVE BALLOON COVER, STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. NO KINKS OR OTHER DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE SAME UNKNOWN INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. NO RESISTANCE/FRICTION WAS FELT WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY PLACED STENT. THERE WERE NO FURTHER ANOMALIES

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10420098 ↗
• MalfunctionMar 12, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AN 8MM X 4CM X 80CM POWER FLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER WAS USED FOR POST-DILATION HOWEVER, IT RUPTURED. THEREFORE, THE DEVICE WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT¿S BODY AND REPLACED WITH A NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). THERE WERE NO DAMAGES NOTED TO THE PACKAGING OF THE DEVICE PRIOR TO USE. THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP AND THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND THROUGH THE GUIDE CATHETER. THE TARGET LESION WAS THE COMMON ILIAC ARTERY (CIA) WHICH HAD NINETY-NINE PERCENT (99%) STENOSIS. THE LESION WAS M

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9823457 ↗
• MalfunctionDec 9, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 6MM X 10CM X 80 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) RUPTURED AT ITS APPROXIMATE RATED BALLOON PRESSURE DURING ITS SECOND INFLATION. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED AS A POST DILATION AFTER A SMART STENT WAS IMPLANTED. THE LESION WAS THE ILIAC ARTERY. THE DEVICE WAS REPLACED WITH ANOTHER BALLOON CATHETER. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9440441 ↗
• MalfunctionNov 20, 2019Material Rupture; Material Rupture

  AS REPORTED, AFTER AN INTRAVASCULAR ULTRASOUND (IVUS), THE USER ATTEMPTED TO INFLATE THE LESION USING THE 8MM 4CM 80 POWERFLEX PRO BALLOON CATHETER (BC), HOWEVER, IT RUPTURED AT ITS NOMINAL PRESSURE DURING THE INITIAL INFLATION. THEREFORE, IT WAS REPLACED WITH ANOTHER DEVICE AND THE PROCEDURE WAS CONTINUED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CASE. THE TARGET LESION WAS THE SUBCLAVIAN VEIN. A NON-CORDIS GUIDEWIRE CROSSED THE STENOSIS PART.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9349993 ↗
• MalfunctionOct 2, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 8MMX4CM 80¿ POWERFLEX PRO BALLOON RUPTURED. THE PROCEDURE WAS THEREFORE COMPLETED WITH ANOTHER BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED DURING A PEDIATRIC CASE. THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DIFFICULTIES REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS, THE PRODUCT FROM THE HOOP, OR THE PROTECTIVE BALLOON COVER. THE DEVICE WAS PREPPED PER THE IFU AND PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED BY MISTAKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9145064 ↗
• MalfunctionSep 2, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING USE, THE POWER FLEX PRO BALLOON CATHETER BURST. THERE WAS NO PATIENT INJURY. THE POWER FLEX PRO WAS REPLACED WITH A NEW BALLOON CATHETER (NON CORDIS) AND THE PROCEDURE WAS CONTINUED. THE TARGET LESION WAS THE SUBCLAVIAN VEIN WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). AN UNKNOWN BALLOON CATHETER (5MM) WAS INSERTED AND INFLATED. AFTER THAT A PROWER FLEX PRO WAS USED FOR SIZE-UP. HOWEVER IT RUPTURED AT ITS NOMINAL PRESSURE. THE DEVICE WAS DISCARDED IN THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8954016 ↗
• MalfunctionMar 22, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AN 8MMX4CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS USED FOR A POST DILATION AFTER A STENT IMPLANTATION, HOWEVER IT RUPTURED. NO PATIENT INJURY WAS REPORTED. THE LESION WAS THE ILIAC ARTERY. THE PHYSICIAN COMMENTED THIS ISSUE MIGHT HAVE OCCURRED AS IT HAD HIT THE STENT EDGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8443269 ↗
• MalfunctionAug 30, 2018Burst Container or Vessel; Burst Container or Vessel

  DURING USE, IT WAS REPORTED THAT THE POWERFLEX PRO BALLOON CATHETER RUPTURED WITHIN ITS RATED BURST PRESSURE AFTER THE BALLOON DELIVERED TO THE LESION AND INFLATED. THERE WAS NO PATIENT INJURY. THE DEVICE WAS REMOVED AND REPLACE WITH AN UNKNOWN NEW BALLOON CATHETER. THE LESION WAS THE ILIAC ARTERY WITH SEVERE CALCIFICATION. THE BALLOON INFLATE NORMALLY DURING PREP. THE SAME INDEFLATOR USED SUCCESSFULLY WITH OTHER DEVICES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7832573 ↗
• MalfunctionAug 21, 2018Burst Container or Vessel; Burst Container or Vessel

  DURING USE, IT WAS REPORTED THAT A POWERFLEX PRO BALLOON CATHETER WAS DELIVERED TO THE LESION AND RUPTURED AT FOUR ATMOSPHERE WHEN THE PHYSICIAN INFLATED THE BALLOON. THERE WAS NO PATIENT INJURY. THE LESION WAS THE EXTERNAL ILIAC ARTERY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS BECAUSE OF INFECTIOUS DISEASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7803159 ↗
• MalfunctionJun 20, 2018Burst Container or Vessel; Burst Container or Vessel

  DURING A ENDOVASCULAR TREATMENT, IT WAS REPORTED THAT POWERFLEX PRO RUPTURED. THERE WAS NO PATIENT INJURY. THE LESION WAS THE ILIAC. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7620852 ↗
• MalfunctionJan 3, 2018Burst Container or Vessel; Difficult to Advance; Burst Container or Vessel; Difficult to Advance

  DURING A STENT GRAFT CASE, IT WAS REPORTED THAT THE POWER FLEX PRO WAS DELIVERED TO THE LESION AND INFLATED, HOWEVER, IT RUPTURED. IT WAS UNKNOWN HOW THE PROCEDURE COMPLETED BUT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE PRODUCT WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7161108 ↗
• MalfunctionJul 28, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A POWER FLEX BALLOON CATHETER RUPTURED AT SIX ATMOSPHERE (6 ATM). THEREFORE THE BALLOON CATHETER WAS REPLACED WITH A NEW POWER FLEX PRO (8*2) AND INFLATED AT TEN (10) ATM. THE PROCEDURE FINISHED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. A 6F BRITE TIP SHEATH INTRODUCER WAS INSERTED AND A SV GUIDEWIRE CROSSED THE LESION. THEN UNDER IVUS (VOLCANO) THE LESION WAS CHECKED AND AN 8*10 SMART STENT WAS DEPLOYED IN THE TARGET LESION. A POWER FLEX PRO WAS DELIVERED TO THE LESION FOR POST DILATATION, HOWEVER IT RUPTURED. THE TARGET LESION WAS UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE DEVICE PREP NORMALLY. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE PRODUCT WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6751547 ↗