NC Emerge® H7493926715300Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08714729846529), received between Feb 26, 2018 and Aug 21, 2025 — classified as 8 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (15 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Oct 24, 2019Class IITerminated

   Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.

   Z-0579-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2025Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED VIA USER FACILITY REPORT (B)(4) THAT BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX CORONARY ARTERY. A 3.00MM X 15MMM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE ANGIOPLASTY PROCEDURE, THE BALLOON DETACHED INTO THE CORONARY ARTERY. NO FURTHER INFORMATION AVAILABLE. IT WAS FURTHER REPORTED THAT THE LESION EXHIBITED SOME TORTUOSITY. THE BALLOON WAS INFLATED THREE OR MORE TIMES, AND THE BALLOON MATERIAL DETACHING FROM THE SHAFT. BECAUSE THE DETACHED MATERIAL WAS NOT VISIBLE ON THE ANGIOGRAM, IT COULD NOT BE REMOVED, AND STENTS WERE DEPLOYED TO SECURE THE BALLOON MATERIAL AGAINST THE VESSEL WALL.

  Patient problems: Foreign Body In Patient

  MAUDE report 22866028 ↗
• MalfunctionAug 19, 2025Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED VIA USER MEDWATCH MW5172924 THAT BALLOON RUPTURE AND SHAFT BREAK OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI). THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.00 X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PHYSICIAN THEN REMOVED THE BALLOON CATHETER WITH HALF OF THE BALLOON STILL ATTACHED. THE REMAINING PORTION OF THE BALLOON WAS SUCCESSFULLY RETRIEVED FROM THE GUIDE CATHETER, WITH NO BALLOON FRAGMENTS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22841420 ↗
• MalfunctionJun 2, 2025Material Rupture; Material Rupture

  SAME CASE AS TW# (B)(4). IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A >90% STENOSED TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 3.00MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 3.00MM X 15MM NC EMERGE BALLOON CATHETER WHICH ALSO RUPTURED AT NOMINAL PRESSURE. THE DEVICE WAS ALSO REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122907 ↗
• MalfunctionJun 2, 2025Material Rupture; Material Rupture

  SAME CASE AS TW# (B)(4). IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A >90% STENOSED TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 3.00MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 3.00MM X 15MM NC EMERGE BALLOON CATHETER WHICH ALSO RUPTURED AT NOMINAL PRESSURE. THE DEVICE WAS ALSO REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122904 ↗
• MalfunctionJul 10, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE >60% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND TORTUOUS DIAGONAL ARTERY. A 3.00MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN THE BALLOON WAS INTRODUCED INTO THE LESION, THE 6-INCH PROXIMAL PART OF THE SHAFT BROKE PARTIALLY OUTSIDE OF THE BODY. THE DETACHED PORTION OF THE DEVICE WAS SIMPLY PULLED OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19716484 ↗
• MalfunctionFeb 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. A 3.00MM X 15MM NC EMERGE BALLOON CATHETER WAS USED FOR TREATMENT. HOWEVER, DURING OPENING OF THE PACKAGE, THE BALLOON CAME APART. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18748421 ↗
• MalfunctionJul 5, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.00MM X 15MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USED. HOWEVER, AFTER LOADING IT ONTO THE NON-BOSTON SCIENTIFIC (BSC) WIRE, IT WAS NOTICED THAT THE CONTRAST HUB AT THE END OF THE WIRE WAS NOT CONNECTED AND FRACTURED ROUGHLY 10 INCHES FROM THE HUB. THE DEVICE WAS REMOVED FROM THE WIRE, AND THE PROCEDURE WAS COMPLETED WITH NEW BALLOON. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT WAS CODED SEVERAL TIMES AND SHOCKED MULTIPLE TIMES DUE TO V TACH BUT IN NO RELATION TO THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17254729 ↗
• MalfunctionJun 12, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INSERTION, THE SHAFT BROKE IN THE MIDDLE WHILE BEING ADVANCED THROUGH GUIDE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17103062 ↗
• MalfunctionFeb 27, 2023Material Rupture; Failure to Advance; Material Rupture; Failure to Advance

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.00MMX15MM NC EMERGE WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE BALLOON COULD NOT CROSS THE LESION. UPON REMOVAL OF THE BALLOON, IT WAS NOTED THAT THE BALLOON BURST. THE BALLOON WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16445004 ↗
• InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENOSIS OCCURRED. THE TARGET LESION WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.0 MM AND LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE SUBJECT WAS ON A PRIOR REGIMEN OF ASPIRIN AND ANTIPLATELET MEDICATIONS OTHER THAN ASPIRIN. A LOADING DOSE OF 243 MG OF ASPIRIN WAS GIVEN PRIOR TO THE PROCEDURE. PRE PROCEDURE ANGIOGRAM NOTED 55% SIDE BRANCH STENOSIS OF THE FIRST DIAGONAL WITH A THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) FLOW OF 3. HEPARIN OR OTHER ANTITHROMBOTIC MEDICATION WERE ADMINISTERED AT THE TIME OF PROCEDURE. THE LESION WAS PRE DILATED WITH A 3.0 MM X 15 MM BALLOON WITH 5% RESIDUAL STENOSIS AND TIMI FLOW OF 3. A 3.0 MM X 15 MM NC EMERGE WAS DEPLOYED SUCCESSFULLY WITH 10% RESIDUAL STENOSIS AND TIMI FLOW 3. POST PROCEDURE ANGIOGRAM NOTED 80% SIDE BRANCH STENOSIS OF THE FIRST DIAGONAL WITH A TIMI FLOW OF 3. THE SUBJECT WAS DISCHARGED WITH ASPIRIN AND CLOPIDOGREL.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16354786 ↗
• MalfunctionAug 19, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE SHAFT WAS NOTED TO BE BROKEN AFTER INSERTION AND IT IS UNCLEAR IF THERE WAS AN ATTEMPT TO INFLATE. THE DEVICE WAS REMOVED AND THERE WERE NO DEVICE FRAGMENTS RETAINED INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15258275 ↗
• InjuryAug 16, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT AN ADVERSE PATIENT EVENT OCCURRED. A 3.00MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE INABILITY TO CROSS THE LESION CAUSED A SIGNIFICANT DELAY TO THE PROCEDURE THAT RESULTED IN AN ADVERSE PATIENT EVENT. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: Insufficient Information

  MAUDE report 15234460 ↗
• InjuryJun 17, 2022Break; Break

  IT WAS REPORTED VIA FACILITY MEDWATCH REPORT (B)(4) THAT SHAFT BREAK, VESSEL DISSECTION, AND EMBOLISM OCCURRED. A HEART CATHETERIZATION WAS PERFORMED IN WORK UP FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). A 3.00MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE BALLOON WAS BACKED OUT, THE SHAFT OF THE BALLOON BROKE OFF "AFTER THE BLACK TIP, PROXIMAL PART OF THE MONORAIL" CAUSING CORONARY ARTERY DISSECTION AND EMBOLIZATION. DISSECTION WAS AT 100% NON-FLOWING AND THERE WAS NO SNARING INVOLVED. THE PHYSICIAN DECIDED TO LEAVE THE BALLOON IN THE VESSEL BECAUSE THE VESSEL WAS POOR. THE PATIENT WAS MONITORED FOR 1.5 HOURS POST PROCEDURE IN THE CATHETERIZATION LAB AND THEN WAS MOVED TO CRITICAL CARE FOR MONITORING AND OVERNIGHT OBSERVATION. AN ECHOCARDIOGRAM WAS PERFORMED TO EVALUATE FOR LEFT EJECTION FRICTION AND REGIONAL WALL MOTION, NO CHANGES WERE NOTED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY AND WILL BE ANTICIPATING TAVR DONE IN 1 MONTH.

  Patient problems: Foreign Body Embolism; Foreign Body In Patient; Vascular Dissection

  MAUDE report 14739238 ↗
• InjuryJun 2, 2022Break; Difficult to Remove; Material Rupture; Break; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED RESULTING IN PATIENT COMPLICATIONS. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED PROXIMAL CIRCUMFLEX ARTERY. THE TARGET LESION WAS WIRED AND BALLOONED WITH AN EMERGE BUT THE LESION DID NOT YIELD. A 3.0 X 15MM NC EMERGE BALLOON WAS THEN PLACED IN THE VESSEL AND INFLATED TO 24 ATMOSPHERES. THE BALLOON RUPTURED ON THE SECOND INFLATION AND WAS STUCK IN THE LESION, DISSECTING THE VESSEL. THE DISSECTION WAS FLOW LIMITING AND THE PATIENT EXPERIENCED SEVERE CHEST PAIN, HEMATOMA, AND THROMBOSIS. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON, THE SHAFT BROKE AT THE MONORAIL TRANSITION. A BUDDY WIRE WAS USED IN AN UNSUCCESSFUL ATTEMPT TO FREE THE STUCK BALLOON. THE ENTIRE MONORAIL AND BALLOON WERE LEFT IN THE PATIENT AND THE PROCEDURE WAS ENDED. THE PATIENT WAS ADMITTED AND CONTINUES TO BE MONITORED. THE PATIENT HAD CHEST PAIN BUT WAS STABLE POST PROCEDURE.

  Patient problems: Chest Pain; Foreign Body In Patient; Hematoma; Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 14579640 ↗
• InjuryMay 27, 2022Break

  MID 70¿S FEMALE WITH HISTORY OF AORTIC STENOSIS, CORONARY ARTERY DISEASE AND POST CABG IN 2001 AND 2014. PROCEDURE: HEART CATH, WORK UP FOR TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). PROBLEM: BALLOON BROKE OFF THE SHAFT CAUSING CORONARY ARTERY DISSECTION AND EMBOLIZATION. BALLOON WAS LEFT IN VESSEL PER PHYSICIAN DECISION. MONITORED OVERNIGHT AND DISCHARGED HOME NEXT DAY. PATIENT MONITORED FOR 1.5 HOURS POST PROCEDURE IN HEART CATH LAB THEN OVERNIGHT OBSERVATION IN THE CRITICAL CARE UNIT. ECHOCARDIOGRAM TO EVALUATE FOR LEFT VENTRICULAR EJECTION FRACTION AND REGIONAL WALL MOTION- NO CHANGES. ANTICIPATE TAVR BEING DONE IN 1 MONTH. PER REP THAT EXAMINED THE DEVICE "IT BROKE AFTER THE BLACK TIP- PROXIMAL PART OF MONOVAIL" AFTER WATCHING THE FILM STATED "IT APPEARED TO BREAK OFF WHEN IT WAS BACKED OUT". MANUFACTURER RESPONSE FOR CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS, NC EMERGE® (PER SITE REPORTER). PER REP THAT EXAMINED THE DEVICE "IT BROKE AFTER THE BLACK TIP- PROXIMAL PART OF MONOVAIL" AFTER WATCHING THE FILM STATED "IT APPEARED TO BREAK OFF WHEN IT WAS BACKED OUT".

  Patient problems: Device Embedded In Tissue or Plaque; Vascular Dissection

  MAUDE report 14521558 ↗
• MalfunctionMay 12, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT MAIN ARTERY, LEFT ANTERIOR DESCENDING ARTERY, AND CIRCUMFLEX ARTERY. A 3.00MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHILE INSERTING THE BALLOON INTO THE TOUHY, THE DEVICE BROKE IN THE MIDDLE OF THE DELIVERY SHAFT. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14377655 ↗
• MalfunctionApr 13, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 3.00MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE PROXIMAL 1/3 PART CLOSER TO THE BALLOON HUB WAS FRACTURED. THE DEVICE WAS PULLED AND WAS REMOVED INTACT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A NON BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14105052 ↗
• MalfunctionMar 10, 2022Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. A 3.00MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. WHILE THE DEVICE WAS BEING PUSHING IN A TIGHT CALCIFIED LESION, ABOUT 1/4TH OF THE PROXIMAL SHAFT FRACTURED. THE DEVICE WAS REMOVED TOGETHER WITH THE WIRE AND THE PROCEDURE COMPLETED WITH ANOTHER EMERGE BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13725828 ↗
• MalfunctionDec 31, 2021Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE COMMON BILE DUCT. A 3.00MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED OVER THE WIRE FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION, A HOLE AND LEAK WAS NOTED. A SECOND 3.00MM X 15MM NC EMERGE BALLOON CATHETER WAS USED FOR DILATATION BUT THE SAME PROBLEM WAS ENCOUNTERED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 06JAN2022. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATION BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT UPON THE FIRST INFLATION THERE WAS A HOLE/LEAK AND THEY WERE NOT ABLE TO COMPLETE THE DILATION. THE SAME ISSUE OCCURRED WITH THE SECOND MAXFORCE BILIARY DILATION BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13124911 ↗
• MalfunctionDec 31, 2021Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE ANATOMY LOCATION WAS LOCATED IN THE COMMON BILE DUCT. A 3.00MM X 15MM NC EMERGE WAS USED FOR DILATION. HOWEVER, WHEN THE BALLOON WAS ADVANCED OVER THE WIRE AND THROUGH THE STRICTURE DURING FIRST INFLATION, A HOLE/LEAK WAS NOTED ON THE BALLOON. THE DILATION WAS NOT COMPLETED. A SECOND 3.00MM X 15MM NC EMERGE WAS USED FOR DILATION BUT ENCOUNTERED THE SAME PROBLEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATION BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT UPON THE FIRST INFLATION THERE WAS A HOLE/LEAK AND THEY WERE NOT ABLE TO COMPLETE THE DILATION. THE SAME ISSUE OCCURRED WITH THE SECOND MAXFORCE BILIARY DILATION BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13124395 ↗
• MalfunctionFeb 17, 2021Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS EXTREMELY TIGHT IN A ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION CASE. A 3.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, THE BALLOON RUPTURED. ANOTHER 3.00MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION BUT IT ALSO RUPTURED DURING PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS EXTREMELY TIGHT AND THE BALLOONS WERE INFLATED AT 8 ATMOSPHERES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11339978 ↗
• MalfunctionDec 4, 2020Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND SHAFT BREAK OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 3.00MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 2 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE MID PART OF THE SHAFT BROKE OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10944578 ↗
• MalfunctionOct 22, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING PREPARATION, A 3.00MM X 15MM NC EMERGE BALLOON CATHETER WAS OPENED. HOWEVER, IT WAS NOTED THAT IT BROKE IN HALF.

  Patient problems: No Patient Involvement

  MAUDE report 10720655 ↗
• InjurySep 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.00MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, UPON REMOVAL, THE BALLOON TIP WAS FRACTURED. THE DETACHED TIP WAS SUCCESSFULLY RETRIEVED BY SNARING AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10560762 ↗
• MalfunctionNov 13, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00MM X 15MM NC EMERGE BALLOON CATHETER WAS USED IN A PROCEDURE. HOWEVER, THE RAIL ON BALLOON BROKE WHILE IN USE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9318223 ↗