POWERFLEX 4400704SRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 20705032059692), received between Mar 6, 2017 and Dec 18, 2023 — classified as 1 injury, 19 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2023Difficult to Remove; Difficult to Remove

  AS REPORTED, THE 7MM X 4CM POWERFLEX PRO WAS UNABLE TO RETRACT AFTER DEFLATION FROM THE 5F NON-CORDIS LONG SHEATH. THE PRODUCT WAS REMOVED INTACT FROM THE PATIENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED IN THE CATH LAB. THE DEVICE WAS STORED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU. THE INTENDED PROCEDURE WAS A PTA OF THE COMMON ILIAC ARTERY. THE LESION WAS NOTED TO HAVE MODERATE CALCIFICATION AND THE VESSEL HAD A LITTLE TORTUOSITY. THE LESION WAS NOTED TO HAVE A STENOSIS OF 70%. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION WITH THE DEVICE. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE DEVICE WAS ONLY INFLATED OR DEFLATED ONCE PRIOR TO REMOVING. THE BALLOON DEFLATED AS INTENDED. THE SALINE/CONTRAST RATIO AND THE INFLATION DEVICE WAS 1:1. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18344241 ↗
• MalfunctionAug 15, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 7MM X 4CM 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING A 14 ATMOSPHERES (ATM) POST-DILATION INFLATION WITHIN AN UNKNOWN IMPLANTED STENT. AS A RESULT, A 7MM X 4CM NON-CORDIS BALLOON CATHETER WAS USED AS A REPLACEMENT TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT AN ILIAC ARTERY LESION WITH SEVERE CALCIFICATION AND MILD TORTUOSITY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO DIFFICULTIES REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THERE WERE NO DIFFICULTIES DELIVERING THE POWERFLEX PRO BALLOON CATHETER WITHIN THE IMPLANTED STENT. THE DEVICE WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17550843 ↗
• MalfunctionApr 7, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 7MM 4CM POWERFLEX PRO WAS USED BUT IT RUPTURED BEFORE IT REACHED ITS NOMINAL PRESSURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS A PTA CASE, AND THE LESION WAS IN THE ILIAC ARTERY. AN UNKNOWN STENT WAS PLACED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION COULD NOT BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16702621 ↗
• MalfunctionMar 14, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 7MM X 4CM 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED BEFORE REACHING ITS NOMINAL PRESSURE DURING THE PRE-DILATION INFLATION OF AN ILIAC ARTERY LESION. AS A RESULT, AN UNKNOWN BALLOON CATHETER WAS USED AS A REPLACEMENT TO CONTINUE THE PROCEDURE. UNKNOWN STENTS WERE THEN IMPLANTED, AND THE PROCEDURE WAS COMPLETED. 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 16539796 ↗
• MalfunctionJan 3, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE POWERFLEX PRO 7MM 4CM RUPTURED DURING THE INITIAL INFLATION. THE POWERFLEX PRO WAS INFLATED AT THE STENOSIS REGION WHICH HAD SEVERE CALCIFICATION. THE PHYSICIAN ATTEMPTED TO HAVE THE PRESSURE RAISE TO 20 ATM BUT THE PRESSURE WAS UNABLE TO RISE OVER ITS RATED BALLOON PRESSURE. THE DEVICE WAS REPLACED WITH ANOTHER POWER FLEX PRO (8 40) AND THE STENOSIS REGION WAS INFLATED AND THE PROCEDURE COMPLETED. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS A SHUNT PTA CASE. 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 DEVICE INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE WAS PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE LESION HAD A 90% STENOSIS. THE DEVICE WAS NOT BEING USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085835 ↗
• MalfunctionAug 15, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE POWERFLEX PRO 7MM 4CM BALLOON RUPTURED BELOW NOMINAL PRESSURE WHILE IN THE EXTERNAL ILIAC ARTERY DURING POST-DILATION. THE CASE WAS COMPLETED WITH A NON-CORDIS BALLOON OF THE SAME SIZE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE LESIONS WERE IN THE ILIAC ARTERY. THE POWERFLEX PRO BALLOON WAS USED FOR PRE-DILATION, THEN FOUR SMART STENTS WERE IMPLANTED. THE DEVICE WAS DISCARDED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15230073 ↗
• MalfunctionDec 8, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 7MM X 4CM 80 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED FOR POST DILATION; HOWEVER, IT RUPTURED UPON INFLATION. IT WAS THEN REPLACED WITH A NON-CORDIS BALLOON CATHETER AND RUPTURED. AN 8MM X 4CM POWERFLEX PRO PTA BALLOON CATHETER WAS USED, INFLATED BY LOW PRESSURE, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE LEFT COMMON ILIAC ARTERY, AND AN APPROACH WAS MADE FROM THE LEFT COMMON FEMORAL ARTERY. A NON-CORDIS STENT WAS USED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED BY MISTAKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12961204 ↗
• MalfunctionMay 27, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 7MM X 4CM X 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED FOR POST-DILATATION, BUT ON THE FIRST INFLATION AT 8 ATMOSPHERIC PRESSURE (ATM), IT RUPTURED. THEY USED THE SAME SIZE POWER FLEX BALLOON CATHETER FOR DILATION. SABER 3MM AND 4CM WERE USED FOR PRE-DILATATION. A NON-CORDIS STENT GRAFT PLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING PRODUCT FROM THE HOOP. NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER, INNER STYLET, OR ANY OTHER OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. THE DEVICE WAS PREPPED NORMALLY. THE PROCEDURE WAS ENDOVASCULAR TREATMENT OF THE ILIAC ARTERY. THE PATIENT HAD MILD CALCIFIED LESIONS IN THE CASE OF STENOSIS OF ILIAC. THE LESION HAD MODERATE CALCIFICATION AND HAD MODERATE TORTUOSITY. THE LESION HAD A 90% STENOSIS. THE DEVICE WAS NOT USED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE HAD NO DIFFICULTY ADVANCING THROUGH THE VESSEL AND CROSSED THE LES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11894102 ↗
• MalfunctionOct 26, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 7MM X 4CM 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED FOR PRE-DILATION; HOWEVER, IT RUPTURED AT ITS NOMINAL PRESSURE DURING INITIAL INFLATION. THEREFORE, AFTER A SMART STENT WAS IMPLANTED ANOTHER UNKNOWN 9MM BALLOON CATHETER WAS INFLATED AS POST DILATION AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS AN ENDOVASCULAR THERAPY (IVT) CASE. THE LESION WAS AT THE EXTERNAL ILIAC ARTERY WITH NINETY PERCENT STENOSIS AND SEVERE CALCIFICATION. THE BALLOON WAS PREPPED, HANDLED AND STORED ACCORDING TO THE IFU. THERE WERE NO DIFFICULTY REMOVING THE PRODUCTS FROM THE HOOP, PROTECTIVE BALLOON COVERS, THE PROTECTIVE BALLOON COVERS, 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. A COMPETITOR¿S INFLATION DEVICE WAS USED. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WERE NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE CATHETER WAS NEVER IN AN ACU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10738177 ↗
• MalfunctionAug 3, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF 7MM X 4CM 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED WITHIN ITS NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE ILIAC ARTERY WHICH WAS MILDLY TORTUOUS AND CALCIFIED WITH SEVENTY PERCENT STENOSIS. THE BALLOON WAS PREPPED, HANDLED AND STORED ACCORDING TO THE INSTRUCTION FOR USE (IFU) WITH NO DIFFICULTY NOTED IN THE BALLOON DURING PREP. 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. A COMPETITOR'S CONTRAST MEDIA AND INFLATION DEVICE WAS USED. THE INFLATION DEVICE WAS SUCCESSFULLY USED WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE, THE GUIDE CATHETER, OR THROUGH THE VESSEL. THE CATHETER HAS NEVER BEEN IN AN ACUTE BEND. THE PRODUCT REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10355417 ↗
• MalfunctionJul 22, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 7MM X 4CM X 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER CROSSED THE LESION AND INFLATED, HOWEVER; IT RUPTURED WITHIN NOMINAL BURST PRESSURE (NBP). THEREFORE, IT WAS REMOVED FROM THE PATIENT¿S BODY AND REPLACED WITH THE SAME SIZE UNKNOWN BALLOON CATHETER. A PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE ILIAC ARTERY. THE LESION HAD SEVERE CALCIFICATION. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED IN THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10308098 ↗
• MalfunctionApr 20, 2020Difficult to Insert; Material Puncture/Hole; Difficult to Insert; Material Puncture/Hole

  AS REPORTED, WHILE PUSHING THE 55 OPTEASE RETRIEVABLE FILTER, THE THORN OF THE FILTER SCRATCHED THE INNER SURFACE OF THE SHEATH TUBE CAUSING THE SHEATH TO BE TORN AND COULD NOT CONTINUE TO PUSH. THE PROCEDURE WAS COMPLETED USING ANOTHER CORDIS FILTER. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS OPENED IN THE STERILE FIELD. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED ACCORDING TO THE IFU. INDICATION FOR FILTER INSERTION WAS FOR DEEP VEIN THROMBOSIS (DVT). THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9977731 ↗
• MalfunctionOct 25, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE POWERFLEX PRO 7MM4CM 80 WAS USED AS A PRE-DILATION BUT IT RUPTURED AT TEN ATMOSPHERES. THERE WERE NO REPORTED PATIENT INJURIES. THE POWERFLEX PRO WAS REPLACED WITH A NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THE LESION WAS THE ILIAC ARTERY WHICH HAD SEVERE CALCIFICATION. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9241179 ↗
• MalfunctionSep 26, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A SMART STENT WAS IMPLANTED AND A POWER FLEX PRO (7 MM 4 CM 80) WAS INSERTED FOR POST DILATION; HOWEVER, IT RUPTURED AT ITS NOMINAL PRESSURE. THERE WAS NO PATIENT INJURY. THE PRODUCT WAS DISCARDED IN THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. THE PRODUCT LOOKED NORMAL WHEN REMOVED FROM ITS PACKAGING. THE DEVICE PREPPED NORMALLY (I.E. MAINTAINED NEGATIVE PRESSURE). THE ACCESS SITE LOCATION WAS THE RIGHT SUPERFICIAL FEMORAL ARTERY. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, OR 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 SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE DEVICE HAD TO PASS THROUGH A PREVIOUSLY PLACED STENT. THE BALLOON INFLATED NORMALLY. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THERE WERE NO OTHER ANOMALIES NOTED WHEN THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9124105 ↗
• MalfunctionJun 18, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A POWERFLEX PRO PTA BALLOON CATHETER (7MM4CM 80) ADVANCED TO THE LESION AND INFLATED; HOWEVER, IT RUPTURED AT 6-ATMOSPHERES ORESSURE (ATM). THERE WAS NO REPORTED PATIENT INJURY. THE POWERFLEX PRO BALLOON CATHETERWAS REMOVED FROM THE PATIENT BODY. THEN, IT WAS REPLACED WITH A NEW SAME SIZE NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THE LESION WAS THE LEFT COMMON FEMORAL ARTERY WITH STENOSIS. THE VESSEL LEVEL OF CALCIFICATION IS SEVERE. THE VESSEL LEVEL OF ANGULATION AND TORTUOSITY IS NONE. INITIALLY, A CONTRALATERAL APPROACH WAS MADE FROM THE RIGHT INGUINAL REGION WITH A 6F GUIDING SHEATH. A GUIDEWIRE (0.035) CROSSED THE LESION AND A CUTTING BALLOON CATHETER (5MM*2CM) WAS INSERTED AND INFLATED. THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREP NORMALLY. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE BALLOON DID NOT INFLATE NORMALLY AS IT WAS RUPTURED. THERE WAS A LEAKAGE NOTED FROM THE BALLOON. THE CATHETER WAS NOT TORQUED AGAINST RESISTANCE. THERE WERE NO KINK/BENT NOTED AFTER THE DEVICE WAS REMOVED FROM PATIENT. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THE DEVICE WAS REMOVE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8707945 ↗
• MalfunctionJun 7, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A POWERFLEX PRO PTA BALLOON CATHETER (7MM4CM 80) WAS INFLATED AFTER A NON-CORDIS BALLOON CATHETER WAS INFLATED. HOWEVER, IT RUPTURED AT 10-ATMOSPHERES PRESSURE (ATM) DURING ITS INITIAL INFLATION. THERE WAS NO REPORTED PATIENT INJURY. THEREFORE, THE POWERFLEX PRO PTA BALLOON CATHETER WAS REPLACED WITH A NEW NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THE LESION WAS THE LEFT COMMON FEMORAL ARTERY. THE LESION HAD HEAVY STENOSIS AND SEEMED TO BE HEAVILY CALCIFIED. INITIALLY, A CONTRALATERAL APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY WITH A NON-CORDIS 6F GUIDING SHEATH AND A NON-CORDIS GUIDEWIRE CROSSED THE LESION. THE DEVICE WILL BE RETURNED FOR ANALYSIS AS THE DEVICE WAS DISCARDED IN THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8679445 ↗
• MalfunctionFeb 21, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 7MMX4CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INFLATED AS A PRE DILATION, HOWEVER IT RUPTURED WITHIN ITS NOMINAL PRESSURE. NO PATIENT INJURY WAS REPORTED. THE LESION WAS THE ILIAC ARTERY. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE POWERFLEX PRO WAS REPLACED WITH A NEW UNKNOWN DEVICE AND THE PROCEDURE WAS COMPLETED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED BY MISTAKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8359409 ↗
• MalfunctionFeb 8, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE PHYSICIAN INSERTED A POWERFLEX PRO (7MM4CM 80) BALLOON CATHETER, AND THERE WAS A SLIGHT RESISTANCE FELT WHEN IT CROSSED THE LESION. AN INDEFLATOR INFLATED THE BALLOON; HOWEVER, THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATM) DURING ITS INITIAL INFLATION AND LEAKAGE OF CONTRAST MEDIA WAS CONFIRMED. THEREFORE, IT WAS REPLACED WITH ANOTHER BALLOON CATHETER OF THE SAME SIZE. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS CHECKED AGAIN USING INTRAVASCULAR ULTRASOUND (IVUS) AND A SMART STENT WAS IMPLANTED. THE PROCEDURE WAS COMPLETED, AND THE DEVICE WAS THEN REMOVED FROM THE PATIENT. THE DEVICE WAS DISCARDED IN THE HOSPITAL DUE TO HOSPITAL REGULATION. THE PRODUCT WAS STORED IN A HYGIENE-MANAGED STORAGE, AND WAS TAKEN OUT FROM ITS TRAY AND INSPECTED, AND NO ANOMALIES WERE NOTED PRIOR TO USE OR DURING BALLOON SET-UP. IT WAS REPORTED THAT AN APPROACH WAS MADE WITH A SHEATH AND A NON-CORDIS GUIDEWIRE, WHICH CROSSED THE LESION (THE ILIAC ARTERY). THE LESION WAS CHECKED VIA IVUS AND DIFFUSE CALCIFICATION WAS CONFIRMED. A RETROGRADE APPROACH WAS MADE FROM THE COMMON FEMORAL ARTERY. THERE WAS MILD VESSEL TORTUOSITY AND NINETY-FIVE PER-CENT STENOSIS. THE DEVICE WAS PREPPED ACCO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8322954 ↗
• InjuryMay 26, 2017Burst Container or Vessel; Detachment Of Device Component; Burst Container or Vessel; Detachment Of Device Component

  IT WAS REPORTED THAT THE POWER FLEX PRO RUPTURED AND SEPARATED IN THE PATIENT¿S LEFT ILIAC ARTERY. THE DOCTOR USED SEVERAL MEDICAL DEVICES OF BIGGER SIZES TO TRY TO REMOVE THE EXPLODED BALLOON FROM THE ARTERY, WITHOUT ANY SUCCESS. THE SEPARATED DEVICE WAS REMOVED FROM THE PATIENT BY ENDOVASCULAR PATH BUT WITH A LOT OF DIFFICULTIES. THERE WAS NO PATIENT INJURY. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGING OR DURING PREP. AN INDEFLATOR WAS USED TO INFLATE THE BALLOON. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6593907 ↗
• MalfunctionMar 6, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A POWER FLEX PRO BALLOON RUPTURE. THEREFORE IT WAS REPLACED WITH A NEW BALLOON CATHETER AND POST-DILATATION WAS PERFORMED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY. AFTER THE STENT DEPLOYMENT, A POWER FLEX PRO WAS INSERTED AND INFLATED. HOWEVER IT BURST. THE TARGET LESION WAS THE BOTH SIDE OF THE ILIAC ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS WAS UNKNOWN. THE LESION WAS CALCIFIED. 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 6379928 ↗