POWERFLEX 4401004SRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 20705032060056), received between Mar 13, 2019 and May 9, 2023 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (15 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2023Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, THE PHYSICIAN USED A POWERFLEX PRO 10MM 4CM BALLOON DEVICE DURING A FISTULAGRAM WITH ANGIOGRAPHIC GUIDANCE. AFTER INFLATION, THE BALLOON POPPED, AND THEN WHEN THE DEVICE WAS BEING REMOVED OUT OF SHEATH, THE TIP WAS SEPARATED FROM CATHETER. THE MD STATED THAT THE PATIENT WAS NOT HARMED DUE TO THE DISTAL TIP BEING RETAINED. THE PHYSICIAN WAS ABLE TO GUIDE A UNKNOWN WIRE THROUGH THE STENT NARROWING SITE AND PLACED INTO THE IVC (INFERIOR VENA CAVA). THE PHYSICIAN THEN PERFORMED BALLOON ANGIOPLASTY OF THE DISTAL SUBCLAVIAN VEIN STENT. THE PHYSICIAN THEN STARTED TO PERFORM BALLOON ANGIOPLASTY OF THE MORE PROXIMAL STENT, BUT THE BALLOON POPPED. THE BALLOON EASILY WITHDREW OUT OF THE STENTS DOWN TO THE UNKNOWN SHEATH. HOWEVER, THE LAST PORTION OF THE BALLOON HAD A VERY DIFFICULT TIME COMING THROUGH THE SHEATH. WITH MILD FORCE, THE TEAM WAS ABLE TO REMOVE IT OVER THE WIRE WHICH CONFIRMED THAT THE BALLOON HAD TORN. BOTH OPAQUE MARKERS WERE VISUALIZED ON THE CATHETER. HOWEVER, THE PHYSICIAN WAS CONCERNED THAT THERE WAS POSSIBLY MORE BALLOON MATERIAL REMAINING ON THE WIRE. THE PHYSICIAN REMOVED THE UNKNOWN 6FR SHEATH AND FLUSHED TO CONFIRM THAT NO MATERIAL WAS WITHIN THE SHEATH. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16898087 ↗
• InjuryApr 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE BALLOON CATHETER TIP OF A POWERFLEX PRO 10MM X 4CM BROKE DURING A BALLOON ANGIOPLASTY OF THE RIGHT SUBCLAVIAN VEIN OF A DIALYSIS CIRCUIT. THE CATHETER TIP DISLODGED INSIDE OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS PROPERLY STORED AND OPENED IN STERILE FIELD. THE USER IS TRAINED TO THE DEVICE. THERE WAS NO LESION CALCIFICATION OR TORTUOSITY AND THE PERCENTAGE STENOSIS WAS BOUT 50-60 PERCENT (%). THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER NOR DIFFICULTY REMOVING THE 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 PREPPED NORMALLY MAINTAINING NEGATIVE PRESSURE. THE SAME INDEFLATOR WAS SUCCESSFULLY USED WITH OTHER DEVICES. THE CONTRAST TO SALINE RATION WAS 25% CONTRAST AND 75% SALINE. NO GUIDE CATHETER WAS USED OR ROTATING HEMOSTATIC VALVE WAS USED FOR THIS PROCED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16772860 ↗
• MalfunctionMar 13, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE POWERFLEX PRO BALLOON BURST WHILE DILATING FISTULA OUTFLOW STENOSIS. THE BALLOON WAS NOTED TO ALMOST COMPLETELY CAME OFF SHAFT. 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 16530107 ↗
• MalfunctionOct 1, 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 10MM 4CM BALLOON BURST OUT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15526002 ↗
• MalfunctionNov 22, 2021Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, A 10MM X 4CM X 80CM POWER FLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INFLATED, BUT THE PRESSURE WENT DOWN, AND THE BALLOON BECAME SHRUNK. THE PHYSICIAN REPEATEDLY INFLATED THE BALLOON TWICE OR THREE TIMES AND THE CONTRAST MEDIUM LEAKED FROM THE SHAFT ABOUT 10CM FROM THE TIP OF THE DEVICE AND WAS VISUALLY CONFIRMED. THE DEVICE WAS REMOVED FROM THE BODY, AND IT WAS OBSERVED THAT THERE WAS A HOLE LIKE A ¿PINHOLE¿ FROM THE SHAFT PART OF THE BALLOON LUMEN. THE GRAPH ANASTOMOSIS WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) CASE. THE FEMORAL ARTERY WAS CUT DOWN AND INSERTED AN 18F UNKNOWN SHEATH (THE FEMORAL ARTERY HAD A GRAFT IMPLANTED). THE POWER FLEX PRO PTA BALLOON WAS USED FOR HEMOSTASIS IN A BALLOON OCCLUSION. THE PHYSICIAN INSERTED THE POWER FLEX PRO PTA INTO THE 18F UNKNOWN SHEATH. THE SHEATH WAS REMOVED AND INFLATED THE POWER FLEX PRO PTA AT 10 ATMOSPHERES (ATM) AROUND THE EXTERNAL ILIAC ARTERY AND DURING THAT TIME A GRAFT ANASTOMOSIS WAS PERFORMED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12852214 ↗
• MalfunctionNov 11, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A POWER FLEX PRO (10MM4CM 80) BALLOON CATHETER WAS USED; HOWEVER, IT RUPTURED AT 6 ATMOSPHERES (ATM). THEREFORE, IT WAS REPLACED WITH A NEW POWER FLEX PRO (9X4) AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT HAD HCB. THE INTENDED PROCEDURE WAS AN ENDOVASCULAR THERAPY (EVT) CASE. 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 DEVICE 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. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE PLUNGER DEPRESSED INTO THE SYRINGE/INDEFLATOR WHEN TRYING TO INFLATE. LEAKAGE WAS NOT NOTED FROM THE BALLOON, SHAFT, HUB, OR OTHER SEGMENT. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. THE BALLOON CATHETER WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12800125 ↗
• MalfunctionDec 9, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 10MM X 4CM X 80 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS USED. HOWEVER, IT RUPTURED AT ITS NOMINAL PRESSURE PROBABLY BECAUSE OF A CALCIFIED LESION. THEREFORE, THE DEVICE WAS REPLACED WITH A NEW SAME SIZE NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS AN ENDOVASCULAR THERAPY (EVT) CASE. THE LESION WAS THE ILIAC ARTERY WHICH HAD STENOSIS. THE PRODUCT LOOKED NORMAL WHEN REMOVED FROM ITS PACKAGING. THE DEVICE PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). THE ACCESS SITE LOCATION WAS THE FEMORAL ARTERY. THE LESION HAD SEVERE CALCIFICATION. THERE WAS NO VESSEL TORTUOSITY. THE PERCENTAGE OF STENOSIS WAS 75%. 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. A NON-CORDIS INFLATION DEVICE WAS USED. 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 F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10976530 ↗
• MalfunctionDec 9, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 10MM X 4CM X 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED WITHIN ITS NOMINAL PRESSURE. IT WAS REPLACED WITH ANOTHER BALLOON CATHETER (NON-CORDIS PRODUCT). THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE ASCENDING AORTA. THE DEVICE WAS USED AS PER THE INSTRUCTIONS FOR USE (IFU) TO PERFORM PLAIN OLD BALLOON ANGIOPLASTY (POBA). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10975860 ↗
• InjuryNov 20, 2020Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, THE MIDDLE PART OF AN UNKNOWN STENT WAS INFLATED WITH 10MM X 4CM X 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC), HOWEVER, IT RUPTURED AT 12 ATMOSPHERIC PRESSURE (ATM). THE PHYSICIAN ATTEMPTED TO REMOVE THE POWERFLEX PRO BUT IT GOT STUCK ON THE DISTAL END OF THE UNKNOWN SHEATH AND THE BALLOON SHAFT GOT SEPARATED. THE SEPARATED DISTAL END OF THE POWERFLEX PRO WAS ON THE NON-CORDIS GUIDEWIRE; THERE WAS A SEPARATION OF THE BODY/SHAFT OF THE CATHETER. ANOTHER UNKNOWN SHEATH (7FR) WAS INSERTED FROM THE MIDDLE OF THE BRACHIAL VEIN. THE GUIDEWIRE WAS GRASPED WITH A NON-CORDIS SNARE AND WITHDRAWN INTO THE SHEATH, WHICH WAS A PULL-THROUGH CONDITION. THE GUIDEWIRE, THE FRAGMENTS, AND THE SHEATH WERE REMOVED TOGETHER FROM THE PATIENT. THE DISTAL END OF THE TIP OF POWERFLEX PRO WAS REMOVED WITH THE GUIDEWIRE. ALL OF THE BALLOON PARTS WERE REMOVED AND THE PROCEDURE COMPLETED. THE PATIENT HAD TO BE PUNCTURED WITH AN ADDITIONAL UNKNOWN SHEATH IN ONE PLACE. OTHER THAN THAT, THERE IS NO PATIENT INJURY. THE PATIENT IS STABLE. THIS WAS A VASCULAR ACCESS INTERVENTION THERAPY (VAIVT) CASE. THE TARGET LESION HAD NO CALCIFICATION, MILD TORTUOSITY, MILD

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10874023 ↗
• MalfunctionJul 14, 2020Material Rupture; Material Rupture

  AS REPORTED, A 10MM X 4CM X 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INSERTED AND ATTEMPTED TO BE INFLATED AT 6 ATMOSPHERES (ATM); HOWEVER, IT RUPTURED DURING ITS INITIAL INFLATION. THEREFORE, IT WAS REPLACED WITH A NEW 6MM X 2CM UNKNOWN CUTTING BALLOON CATHETER. AFTER THAT, ANOTHER SAME SIZE NON-CORDIS BALLOON CATHETER WAS INFLATED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE COMMON ILIAC ARTERY. THE LESION HAD SEVERE CALCIFICATION AND ¿CIRCUMSCRIBED¿ STENOSIS. AN IPSILATERAL APPROACH WAS MADE WITH A 6F 25CM NON-CORDIS SHEATH. A 175CM NON-CORDIS GUIDEWIRE WAS INSERTED AND CROSSED THE LESION. AN INTRAVENOUS ULTRASOUND WAS PERFORMED AND CHECKED THE LESION. 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 10271038 ↗
• MalfunctionJun 18, 2020Burst Container or Vessel; Burst Container or Vessel

  DURING USE OF THE 10MM X 4CM 80 POWERFLEX PRO BALLOON CATHETER, THE BALLOON RUPTURED DURING ITS INITIAL INFLATION. THEREFORE, THE DEVICE WAS REPLACED WITH ANOTHER UNKNOWN BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE ILIAC ARTERY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10168008 ↗
• MalfunctionMar 20, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 10MM X 4CM X 80 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS USED. HOWEVER, IT RUPTURED WITHIN ITS NOMINAL BURST PRESSURE (NBP). THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE ILIAC ARTERY WITH SEVERE CALCIFICATION. THE DEVICE WILL NOT TO BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED IN THE HOSPITAL. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9860308 ↗
• MalfunctionMar 6, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 10MM 4CM 80 POWERFLEX PRO RUPTURED DUE TO SEVERE CALCIFICATION. THE BALLOON BURST AT 1 ATMOSPHERIC PRESSURE (ATM). THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE ILIAC ARTERY. THERE WAS MODERATE VESSEL TORTUOSITY. THE PERCENTAGE OF STENOSIS WAS AT 90 PERCENT. THE DEVICE WAS NOT USED FOR CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3MONTHS). THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY 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 INSTRUCTIONS FOR USE (IFU). 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. 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 B

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9801577 ↗
• MalfunctionFeb 26, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 10MM X 4CM 80 POWERFLEX PRO BALLOON CATHETER WAS USED BUT IT RUPTURED AT SIX ATMOSPHERES (ATM). THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9758317 ↗
• MalfunctionJul 30, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 10MMX4CM 80¿ POWERFLEX BALLOON WAS INTENDED TO BE USED FOR POST-DILATION FOLLOWING A STENT IMPLANTATION. HOWEVER, THE BALLOON RUPTURED AS IT MIGHT HAVE TOUCHED THE STENT EDGE. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE ILIAC ARTERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8841606 ↗
• MalfunctionJul 1, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 10X4 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED FOR PREPARATION, HOWEVER IT RUPTURED DUE TO SEVERE CALCIFICATION. NO PATIENT INJURY WAS REPORTED. THE LESION WAS THE ILIAC ARTERY. A NON-CORDIS GUIDEWIRE CROSSED THE LESION. THE POWERFLEX PRO WAS REPLACED WITH A NEW, NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THE PATIENT HAD NO INFECTIOUS DISEASE HOWEVER THE DEVICE WAS DISCARDED IN THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8748322 ↗
• MalfunctionJun 17, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THIS WAS A PEDIATRIC CASE AND A POWERFLEX PRO 10MM4CM 80 WAS USED, HOWEVER; IT RUPTURED. THERE WERE NO REPORTED PATIENT INJURIES. THE DEVICE WAS BROUGHT IN THE MORNING OF THE OF THE PROCEDURE. THE DEVICE WAS STORED IN THE CATH LAB FOR ABOUT ONE HOUR. THE DEVICE WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEICE WAS PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. 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 SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE BALLOON CATHETER WAS REMOVED EASILY. THE TARGET LESION WAS THE ARTIFICIAL BLOOD VESSEL. THE LESION WAS SEVERELY CALCIFIED. THERE WAS NO VESSEL TORTUOSITY. THERE WAS EIGHTY PERCENT STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE PROCEDURE WAS COMPLETED BY IMPLANTING A PALAMAZ XL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8704847 ↗
• MalfunctionMar 13, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS INSERTED FOR A POST DILATION AFTER A STENT WAS IMPLANTED IN THE ILIAC ARTERY, THE BALLOON RUPTURED AS IT HIT THE STENT EDGE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8416551 ↗