Advance G52359Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10827002523590), received between Sep 15, 2015 and Jul 25, 2024 — classified as 1 death, 11 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (25 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2024Break; Material Rupture; Break; Material Rupture

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE IN A RADIOLOGY DEPARTMENT, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER'S BALLOON "SNAPPED" AT SIX ATMOSPHERES. THE RADIOLOGIST WAS THEN UNABLE TO PULL THE DEVICE BACK INTO AN UNKNOWN SHEATH. A VASCULAR SURGEON FINISHED THE PROCEDURE IN THE OPERATING ROOM, AND THE DEVICE WAS PULLED OUT AFTER THE GROIN WAS OPENED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19829072 ↗
• MalfunctionNov 9, 2023

  COOK MEDICAL ADVANCE 35LP LOW PROFILE PTA BALLOON DILATION CATHETER RUPTURED DURING USE.

  Patient problems: Insufficient Information

  MAUDE report 18121651 ↗
• MalfunctionFeb 28, 2022Break; Fracture; Material Rupture; Material Separation; Break; Fracture; Material Rupture; Material Separation

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE INVOLVING THE ILIAC ARTERY, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED. THE DEVICE WAS INSERTED VIA CONTRALATERAL ACCESS. THE VESSEL WAS HEAVILY CALCIFIED. THE BALLOON RUPTURED AFTER BEGINNING INFLATION. THE BALLOON THEN BECAME "CAUGHT" WITHIN THE VESSEL, AND THE SHAFT STRETCHED AS THE DEVICE WAS ATTEMPTED TO BE REMOVED. AFTER MULTIPLE ATTEMPTS, THE DEVICE WAS ABLE TO BE REMOVED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13618147 ↗
• MalfunctionDec 1, 2021Material Rupture; Material Rupture

  AS REPORTED, DURING A PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE ILIAC ARTERY, THE BALLOON OF A ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED ON THE FIRST INFLATION INSIDE OF THE PATIENT. THE BALLOON WAS REMOVED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE ALLEGED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12909646 ↗
• MalfunctionNov 4, 2021Material Rupture; Material Rupture

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752463 ↗
• InjuryJul 13, 2021Material Rupture; Material Separation; Material Rupture; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED. ACCESS WAS OBTAINED WITH AN 18 GAUGE NEEDLE. THE STENOSED AREA, DESCRIBED AS A "VERY FIBROSED STRICTURE", WAS CROSSED WITH ANOTHER MANUFACTURER'S WIRE AND WAS THEN EXCHANGED FOR AN UNKNOWN 180-CENTIMETER J WIRE. A 6- MILLIMETER COOK BALLOON WAS INFLATED TO 16-18 ATMOSPHERES. THE STENOSIS DID NOT IMPROVE AND THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT. THE 6MM BALLOON RUPTURE IS CAPTURED UNDER PATIENT IDENTIFIER (B)(6). THE 8-MILLIMETER BALLOON WAS THEN USED AND RUPTURED (SUBJECT OF THIS REPORT). AFTER REMOVAL, THE USER INSPECTED THE BALLOON AND FOUND THE TIP OF THE BALLOON AND CATHETER WERE MISSING. THIS WAS ALSO VISUALIZED ON FLUOROSCOPY OF THE LEFT ARM. THE SHEATH WAS UNABLE TO BE ADVANCED OVER THE FRAGMENT. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL VEIN AND A "600" SAFETY BALLOON WAS INFLATED DISTAL TO THE BALLOON FRAGMENT. THE LEFT ARM VENOUS SHEATH WAS UPSIZED TO A 10 FRENCH SHEATH, AND ANOTHER MANUFACTURER'S SNARE WAS USED TO SUCCESSFULLY RETRIEVE THE BALLOON CATHETER. THE CEPHALIC STENOSIS WAS THEN STENTED WITH ANOTHER MANUFACTURER'S 7X39 COVERED STENT WITH A GOOD RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12159627 ↗
• InjuryDec 29, 2020Material Rupture; Material Separation; Material Rupture; Material Separation

  AS REPORTED, DURING AN AORTOILIOFEMORAL (AIF) PROCEDURE TO OPEN THE SUPERFICIAL FEMORAL ARTERY, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED AND SEPARATED. THE ILIAC ARTERIES WERE REPORTEDLY EXTREMELY CALCIFIED BUT WERE NOT TORTUOUS OR ANGULATED. A 6 FRENCH SHEATH WAS UNABLE TO BE ADVANCED VIA THE LEFT GROIN INTO THE RIGHT ILIAC, SO THE COMPLAINT DEVICE WAS USED TO OPEN THE STENOSED EXTERNAL ILIAC ARTERY. THE BALLOON WAS INFLATED USING AN INFLATION DEVICE AND VISIPAQUE CONTRAST; HOWEVER, THE BALLOON RUPTURED AND SEPARATED UPON THE FIRST INFLATION. THE DEVICE WAS REMOVED, AND ANOTHER MANUFACTURER'S SNARE WAS USED TO RETRIEVE THE SEPARATED BALLOON FRAGMENTS. BLOOD WAS NOTED IN THE INFLATION DEVICE AFTER THE BALLOON RUPTURED. THE BALLOON WAS NOT INFLATED WITHIN A STENT. THE ACCESS SITE WAS CLOSED, AND THE PATIENT WAS TRANSPORTED TO A HOSPITAL FOR FURTHER TREATMENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 11086886 ↗
• MalfunctionOct 16, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING A FISTULOPLASTY IN THE CEPHALIC VEIN IN THE LEFT UPPER ARM, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WOULD NOT INFLATE AND WAS LATER FOUND TO HAVE A HOLE IN THE BALLOON. THE COMPLAINT DEVICE WAS ADVANCED OVER AN UNKNOWN GUIDEWIRE TO THE 75% OCCLUDED LESION. ANOTHER MANUFACTURER¿S 5 FRENCH SHEATH WAS USED DURING THE PROCEDURE. THE USER ATTEMPTED TO INFLATE THE BALLOON WITH AN INFLATION DEVICE, USING A 50/50 SOLUTION OF OMNIPAQUE 240 CONTRAST TO SALINE. THE BALLOON WOULD NOT INFLATE TO NOMINAL PRESSURE AND DECOMPRESSED WHEN INFLATION ATTEMPTS WERE CEASED. THE BALLOON WAS REMOVED OVER THE WIRE, AND A SMALL HOLE WAS OBSERVED ON THE BALLOON UPON ATTEMPTED INFLATION WITH A SYRINGE, OUTSIDE THE BODY. MILD INTIMAL CALCIFICATION BUT NO ANGULATION OR TORTUOSITY WERE REPORTED. BLOOD WAS NOTED IN THE INFLATION DEVICE AFTER THE SECOND INFLATION ATTEMPT. THE BALLOON WAS NOT REMOVED AND REINSERTED BETWEEN ATTEMPTED INFLATIONS. THE BALLOON WAS NOT INFLATED WITHIN A STENT. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT. THIS DID NOT RESULT IN ANY ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATION. THERE WERE NO ADVER

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10692949 ↗
• MalfunctionAug 7, 2020Material Rupture; Material Rupture

  AS REPORTED, DURING A ANGIOPLASTY AND STENTING PROCEDURE A ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS IN USE, BUT BURST AFTER DILATION OF THE STENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PORTION OF THE DEVICE WAS LEFT INSIDE THE PATIENT. THIS DID NOT REQUIRE THE PATIENT TO HAVE ADDITIONAL PROCEDURES OR A PROLONGED HOSPITALIZATION. NO ADVERSE EFFECTS TO THE PATIENT OCCURRED DUE TO THIS INCIDENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND A FOLLOW-UP REPORT WILL BE SUBMITTED IF/WHEN THE INFORMATION IS RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10379201 ↗
• MalfunctionAug 4, 2020Material Rupture; Material Rupture

  AS REPORTED, DURING AN ANGIOGRAPHY AND STENTING OF THE LEFT COMMON ILIAC ARTERY AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS PLACED THROUGH THE LEGION AND INFLATED AS NORMAL WITH AN UNKNOWN 50/50 SOLUTION OF CONTRAST, BUT BURST LONGITUDINALLY BEFORE REACHING NOMINAL PRESSURE. THE RUPTURED BALLOON WAS THEN REMOVED AND REPLACED WITH ANOTHER MANUFACTURER'S BALLOON OF THE SAME SIZE WITHOUT ISSUE. THE BALLOON HAD BEEN INFLATED TO 8 ATM AT THE TIME IT BURST. IT WAS NOTED THE VESSEL WAS SEVERELY CALCIFIED. NO PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT. IT DID NOT LEAD ANY ADDITIONAL PROCEDURES. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10362013 ↗
• InjuryMay 27, 2020Material Rupture; Material Separation; Material Rupture; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Code Available

  MAUDE report 10092137 ↗
• MalfunctionMar 18, 2020Material Rupture; Material Rupture

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9848368 ↗
• MalfunctionAug 8, 2019Material Rupture; Material Rupture

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8874276 ↗
• MalfunctionApr 5, 2019Material Rupture; Material Rupture

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8486549 ↗
• MalfunctionMar 26, 2019Material Rupture; Material Rupture

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8453458 ↗
• MalfunctionMay 17, 2018Material Rupture; Material Rupture

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. REFER TO SECTION H10 FOR INVESTIGATION FINDINGS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7523271 ↗
• DeathMar 7, 2018Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT DURING AN ILIAC ANGIOPLASTY (AS A PRECURSOR FOR FEMORAL POPLITEAL BYPASS) AT NOON ON (B)(6) 2018, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS EASILY INSERTED, INCOMPLETELY INFLATED ONCE TO BELOW NOMINAL PRESSURE, RUPTURED AND SEARED OFF INSIDE OF THE PATIENT AT A PRESSURE LESS THAN 8 ATM. THE PHYSICIAN STATED HE WAS WATCHING THE SCREEN WHEN THE BALLOON BURST AND HE IS NOT ABLE TO CLARIFY THE ACTUAL PRESSURE THE BALLOON BURST AT. THE BALLOON CATHETER MARKERS ALSO CAME OFF WITHIN THE PATIENT'S ANATOMY. A 50:50 RATIO OF CONTRAST TO SALINE WAS UTILIZED DURING THE PROCEDURE. ANOTHER MANUFACTURER'S 4 FR SHEATH WITH A RADIO-OPAQUE TIP AND AN AMPLATZ WIRE GUIDE (MANUFACTURER UNSPECIFIED) WERE UTILIZED DURING THE PROCEDURE. THE PATIENT'S EXTERNAL ILIAC ARTERY (EIA) WAS NOTED TO BE SIGNIFICANTLY CALCIFIED AND TIGHT. ACCESS TO THE LESION (FOCAL STENOSIS - VESSEL APPROXIMATELY 8 MILLIMETERS) AT THE COMMON ILIAC ARTERY (CAI) / EXTERNAL ILIAC ARTERY (EIA) JUNCTION WAS GAINED VIA AN IPSILATERAL APPROACH; THERE WAS 5 TO 10 CENTIMETERS (CM) BETWEEN THE END OF THE 4 FR SHEATH WITH RADIO-OPAQUE TIP. UPON WITHDRAWAL OF THE RUPTURED ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

  Patient problems: Cardiac Arrest; Death; Deformity/ Disfigurement

  MAUDE report 7322430 ↗
• InjuryFeb 22, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A COMMON ILIAC ARTERY ANGIOPLASTY FROM A CROSS-OVER AORTIC BIFURCATION, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED CIRCUMFERENTIALLY AT AN INFLATION PRESSURE OF APPROXIMATELY 14- 15 ATMOSPHERE (ATM) INSIDE OF THE PATIENT'S ANATOMY. IT WAS NOTED THAT THE PATIENT'S VESSEL WAS HEAVILY CALCIFIED; THE CUSTOMER STATED THAT THE RUPTURE WAS DUE TO THE CALCIFICATION. THE BALLOON CATHETER WAS ATTEMPTED TO BE REMOVED THROUGH ANOTHER MANUFACTURER'S SIX (6) FR SHEATH; HOWEVER, ONLY THE PROXIMAL PORTION OF THE BALLOON WAS RETRIEVED. THE DISTAL PORTION REMAINED ON THE AMPLATZ WIRE GUIDE, AND WAS UNABLE TO BE REMOVED THROUGH THE SHEATH. ANOTHER MANUFACTURER'S SEVEN (7) FR SHEATH WAS ADVANCED OVER THE WIRE GUIDE AND REMAINING DISTAL BALLOON PORTION, AND THE RETRIEVAL WAS SUCCESSFULLY COMPLETED. THE SITE WAS CLOSED USING ANOTHER MANUFACTURER'S SUTURE CLOSING DEVICE; NO FURTHER INTERVENTION WAS REQUIRED. THE PATIENT EXPERIENCED BLOOD LOSS AND A BLOOD PRESSURE DROP TO FIFTY (50) DURING THE SHEATH EXCHANGE AND RETRIEVAL. A COOK SPHERE INFLATION DEVICE WAS USED DURING THE PROCEDURE. ANGULATION OF APPROXIMATELY THIRTY (30) DEGREES WAS NOTED.

  Patient problems: Diminished Pulse Pressure; No Code Available

  MAUDE report 7288511 ↗
• InjuryDec 20, 2017Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT DURING AN ILIAC ANGIOPLASTY, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER CIRCUMFERENTIALLY RUPTURED AND SEPARATED INTO TWO PIECES. ONE OF THE PIECES REMAINED INSIDE OF THE PATIENT'S ANATOMY AND WAS REQUIRED TO BE RETRIEVED USING A LASSO DEVICE. A MAXIMUM PRESSURE OF 12 ATMOSPHERE (ATM) WAS UTILIZED DURING THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 7135411 ↗
• MalfunctionDec 7, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ARTERIOVENOUS (AV) FISTULA ANGIOPLASTY, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED CIRCUMFERENTIALLY AT 12 ATMOSPHERE (ATM). ANOTHER MANUFACTURER'S EIGHT (8) FR SHEATH, AND A WIRE GUIDE WERE BEING UTILIZED THROUGH THE SHEATH DURING THE EVENT. THE PATIENT'S LESION WAS LOCATED IN THE CEPHALIC ARCH; CALCIFICATION WAS PRESENT IN THE FIBROTIC VEIN. THE PROCEDURE WAS ABLE TO BE SUCCESSFULLY COMPLETED UTILIZING ANOTHER BALLOON CATHETER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7095455 ↗
• InjuryDec 6, 2017Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT DURING AN ATRIOVENTRICULAR (AV) FISTULA ANGIOPLASTY, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED TRANSVERSELY INTO TWO PIECES. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE ALL PIECES OF THE BALLOON CATHETER FROM THE PATIENT'S ANATOMY WITH A RETRIEVAL SET AFTER SEVERAL TRIES. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED PAIN DURING THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 7087355 ↗
• InjuryNov 15, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ATRIOVENTRICULAR (AV) FISTULOPLASTY (VENOPLASTY), THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS INFLATED TO 14 ATM, AND THEN RUPTURED. THE BALLOON CATHETER WAS PROMPTLY WITHDRAWN, AND ANOTHER MANUFACTURER'S BALLOON CATHETER WAS UTILIZED TO SNAG AND REMOVE THE REMNANT FROM THE PATIENT'S ANATOMY THROUGH THE LARGER SHEATH. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7035479 ↗
• InjuryOct 20, 2017Material Separation; Material Separation

  TWO ADVANCE 35 LP LOW PROFILE BALLOON CATHETERS WERE USED IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE SUPERFICIAL FEMORAL ARTERY. IT WAS REPORTED THAT THE FIRST BALLOON (1820334-2017-03626) BURST AT THE INTERSECTION, BUT WAS STILL ABLE TO BE PULLED THROUGH THE INTRODUCER. A SECOND BALLOON (1820334-2017-03627) RIPPED APART INTO TWO PIECES AND WAS RETRIEVED WITH A SNARE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 6966580 ↗
• MalfunctionJul 28, 2017Hole In Material; Inflation Problem

  THE END USER GAINED ACCESS THROUGH BOTH FEMORAL ARTERIES TO PLACE ANOTHER MANUFACTURE'S STENT THE END USER ATTEMPTED TO INFLATE THE BALLOONS WITH 2 ATM BY KISSING BALLOON TECHNIQUE. THE BALLOON CATHETER WHICH WAS INSERTED INTO THE LEFT ILIAC ARTERY WOULD NOT INFLATE. PRESSURE WAS NOT INCREASED, EVALUATION OF THE BALLOON REVEALED A PIN HOLE LOCATED 2CM FROM THE DISTAL BALLOON BOND. ANOTHER MANUFACTURE'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECT TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6749815 ↗
• MalfunctionJul 27, 2017Material Rupture

  IT WAS REPORTED THAT DURING THE PATIENT'S RIGHT COMMON ILLIAC INTERVENTION PROCEDURE, THE BALLOON RUPTURED AT 6 ATM. IT IS UNKNOWN IN WHAT DIRECTION THE BALLOON RUPTURED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6748342 ↗