NC Emerge® H7493926712350Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 08714729846413), received between Aug 20, 2018 and Apr 17, 2026 — classified as 6 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT REMOVAL DIFFICULTY AND DEFLATION ISSUE OCCURRED RESULTING IN A PROLONGED PROCEDURE. THE PATIENT WAS BEING TREATED FOR OCCLUSION AND UNDERWENT AN ANGIOPLASTY PROCEDURE. A 3.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON WAS INFLATED INSIDE THE PATIENT; HOWEVER, THE BALLOON COULD NOT BE DEFLATED, AND REMOVAL DIFFICULTY WAS EXPERIENCED. THE BALLOON WAS REMOVED FROM THE PATIENT IN THE INFLATED STATE. A SECOND 3.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ALSO ADVANCED; BUT THE SAME ISSUE OCCURRED, RESULTING IN PROLONGATION OF THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913617 ↗
• MalfunctionApr 17, 2026Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT REMOVAL DIFFICULTY AND DEFLATION ISSUE OCCURRED RESULTING IN A PROLONGED PROCEDURE. THE PATIENT WAS BEING TREATED FOR OCCLUSION AND UNDERWENT AN ANGIOPLASTY PROCEDURE. A 3.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON WAS INFLATED INSIDE THE PATIENT; HOWEVER, THE BALLOON COULD NOT BE DEFLATED, AND REMOVAL DIFFICULTY WAS EXPERIENCED. THE BALLOON WAS REMOVED FROM THE PATIENT IN THE INFLATED STATE. A SECOND 3.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ALSO ADVANCED; BUT THE SAME ISSUE OCCURRED, RESULTING IN PROLONGATION OF THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24912536 ↗
• MalfunctionDec 21, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. AFTER A 6FR NON-BSC GUIDE CATHETER WAS INSERTED, A 3.50 MM X 12 MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, THE SHAFT WAS BROKEN INSIDE THE GUIDE CATHETER. BOTH DEVICES WERE REMOVED TOGETHER, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23860385 ↗
• MalfunctionJan 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 3.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 18 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21223746 ↗
• InjuryJan 15, 2025Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED REQUIRING ADDITIONAL INTERVENTION. DURING THE PROCEDURE, A STENT WAS IMPLANTED, AND A 3.50MM X 12MM NC EMERGE BALLOON CATHETER WAS PLACED INTO THE VESSEL TO PERFORM POST-DILATATION. HOWEVER, THE BALLOON RUPTURED DURING INFLATION, CAUSING PIECES OF THE BALLOON TO EMBOLIZE FURTHER INTO THE VESSEL. ATTEMPTS WERE MADE TO REMOVE THE SEPARATED BALLOON PIECES USING A SNARE DEVICE, BUT NOT ALL PIECES COULD BE SUCCESSFULLY REMOVED. ULTIMATELY, A PIECE OF THE BALLOON MATERIAL WAS LEFT IN ONE OF THE PATIENT'S DISTAL RIGHT CORONARY ARTERY (RCA) BRANCHES. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE PATIENT'S OUTCOME OR ANY ADDITIONAL INTERVENTIONS.

  Patient problems: Embolism/Embolus; Foreign Body In Patient

  MAUDE report 21163530 ↗
• MalfunctionJun 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. DURING PERCUTANEOUS CORONARY INTERVENTION, A 3.00MM X 12MM AND 3.50MM X 12MM NC EMERGE BALLOON CATHETERS WERE ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, BOTH BALLOONS RUPTURED. THE DEVICES WERE REMOVED WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19520806 ↗
• InjuryDec 22, 2023Break; Entrapment of Device; Material Rupture; Detachment of Device or Device Component; Break; Entrapment of Device; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE, BALLOON DETACHMENT, SHAFT BREAK AND CATHETER ENTRAPMENT OCCURRED. THE PATIENT HAD TWO LAYERS OF AN UNKNOWN STENT THAT HAD IN-STENT RESTENOSIS. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 3.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION OF THE LESION FOR A THIRD LAYER OF STENT. HOWEVER, DURING THE INITIAL INFLATION AT 16 ATM FOR 20 SECONDS, THE BALLOON RUPTURED. THE PHYSICIAN PULLED THE DEVICE OUT; HOWEVER, THE INNER SHAFT OF THE BALLOON BROKE LEAVING BEHIND THE DISTAL PART OF THE BALLOON SEVERED AND STUCK ON THE WIRE. A SECOND WIRE WAS DELIVERED TO RCA PAST THE LOOSE BALLOON AND A SECOND EMERGE BALLOON WAS PLACED ON THE SECOND WIRE IN ORDER TO INFLATE AND TRAP THE DETACHED PIECE OF THE BALLOON. THE DETACHED PORTION WAS REMOVED, AND NO DEVICE FRAGMENTS WERE LEFT INSIDE THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18385906 ↗
• InjuryApr 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE DETACHMENT REQUIRING INTERVENTION OCCURRED. A 3.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON CAME OFF OF THE DELIVERY SYSTEM. A SYNERGY XD STENT WAS IMPLANTED TO TRAP THE BALLOON WHICH WAS LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE FOLLOWING DAY, THE PATIENT EXPERIENCED ADDITIONAL SYMPTOMS AND ANOTHER LEFT CATHETERIZATION (LHC) WAS PERFORMED. IT WAS CONFIRMED THAT THE PATIENT HAD GOOD BLOOD FLOW AND NO ADDITIONAL INTERVENTION WAS NEEDED. THE PATIENT FULLY RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16686997 ↗
• MalfunctionJul 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PERFORATION OCCURRED. A 3.50MM X 12MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE; HOWEVER, IT WAS NOTED THAT THE BALLOON WAS PERFORATED UPON OPENING. THE PROCEDURE WAS CANCELLED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15002509 ↗
• MalfunctionAug 25, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHILE PUSHING THROUGH THE SHEATH, THE SHAFT BREAK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE CONDITION OF THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12367582 ↗
• MalfunctionAug 3, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED, TARGET LESION WAS LOCATED IN THE MILLY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 3.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED OR TREATMENT. HOWEVER, DURING THE PROCEDURE, SHAFT BREAK OCCURRED. BALLOON WAS NOT INFLATED PRIOR BREAKING. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12270449 ↗
• MalfunctionJul 14, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MODERATELY TORTUOUS CORONARY ARTERY. A 3.50MM X 12MM EMERGE BALLOON CATHETER KINKED AS IT WAS BEING INSERTED. AS THE DEVICE WAS BEING REMOVED IT BROKE IN TWO PIECES. THE EMERGE CATHETER WAS NOT FULLY INSERTED INTO THE PATIENT SO THE BROKEN CATHETER WAS REMOVED WITH THE PHYSICIAN HAND. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12168190 ↗
• MalfunctionJun 11, 2021Difficult to Remove; Difficult to Advance; Material Integrity Problem; Difficult to Remove; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT DIFFICULTY IN REMOVAL WAS OBSERVED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.50MM X 12MM NC EMERGE BALLOON CATHETER WAS HAVING DIFFICULTY IN ADVANCING IN PREDILATING THE VESSEL DUE TO THE WINGING OF THE BALLOON. FURTHERMORE, THE DEVICE WAS HAVING DIFFICULTY IN REMOVAL AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11987930 ↗
• MalfunctionFeb 12, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50MM X 12MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING INTRODUCTION OF THE BALLOON IN THE GUIDE CATHETER, IT WAS NOTED THAT THE DISTAL SHAFT OF THE BALLOON BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11323887 ↗
• InjuryDec 10, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.5X12 NC EMERGE WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE REMOVAL OF THE DEVICE, THE BALLOON BROKE IN HALF AT THE MID SHAFT. THE PHYSICIAN ADVANCED A SECOND WIRE DOWN AND WRAPPED THE DISTAL SHAFT BETWEEN THE WIRES. THE PHYSICIAN SUCCESSFULLY REMOVED THE DEVICE FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

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

  MAUDE report 10985307 ↗
• MalfunctionOct 1, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, IT WAS NOTED THAT THE SHAFT BROKE AT THE 90CM MARKER BAND ON THE SHAFT. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10613421 ↗
• MalfunctionAug 31, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.50MM X 12MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING INSERTION IN THE GUIDE CATHETER, THE SHAFT OF THE BALLOON CATHETER BROKE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS PULLED OUT AND COMPLETELY REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10473112 ↗
• InjuryMar 12, 2020Inflation Problem; Leak/Splash; Material Integrity Problem; Inflation Problem; Leak/Splash; Material Integrity Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED CARDIAC ARREST. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX CORONARY ARTERY (LCX). AFTER PRE-DILATION WAS PERFORMED WITH A 2.5X12MM UNSPECIFIED BALLOON CATHETER, A 3.5MM UNSPECIFIED STENT WAS THEN PLACED IN THE LCX. THEN POST-DILATION WAS TRIED TO PERFORM USING A 3.50MM X 12MM NC EMERGE BALLOON CATHETER. HOWEVER, THE ATMOSPHERIC PRESSURE OF THE BALLOON WAS NOT INCREASING TO THE CORRECT PROCEDURAL PRESSURE AND WAS ONLY READING AT 8, WHICH IS VERY LOW, THEN THE PRESSURE BEGAN TO DROP. AS THE BALLOON WAS RETRACTED, THE PATIENT STARTED TO SEIZURE AND THIS QUICKLY ESCALATED INTO A HYPOTENSIVE EVENT FROM NO CORONARY FLOW TO THE LEFT SIDE OF THE HEART. CARDIO-PULMONARY RESUSCITATION AND CHEST COMPRESSIONS WERE ADMINISTERED, AND A CODE CART WAS CALLED. AFTER A WHILE, SPONTANEOUS RETURN OF CIRCULATION OCCURRED WITHIN THE HEART AND THE BLOOD PRESSURE RETURNED TO NORMAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. POST PROCEDURE, IT WAS OBSERVED THAT THERE WAS A CRACK IN THE LINE, ABOUT AN INCH DOWN FROM THE BALLOON ON THE SHAFT OF THE WIRE. THEY WERE ABLE TO TEST IT WITH AIR FLOW PRESSURE AND COULD POSITIVELY SE

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension; Seizures

  MAUDE report 9825329 ↗
• MalfunctionOct 7, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2019 IT WAS REPORTED THAT SHAFT KINKED OCCURRED. A 3.50MM X 12MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR TREATMENT. HOWEVER, THE DELIVERY SHEATH OF THE DEVICE WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A SEPARATION AT 138.3CM PROXIMAL OF THE TIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9162601 ↗
• MalfunctionSep 24, 2019Contamination; Contamination

  IT WAS REPORTED THAT DEVICE STERILITY WAS COMPROMISED. DURING PREPARATION OF A 3.50MM X 12MM NC EMERGE BALLOON CATHETER, IT WAS NOTICED THAT THERE WAS A HANDWRITTEN NOTE ON THE BACK OF THE INTERNAL STERILIZED PACKAGING. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9111484 ↗
• MalfunctionAug 16, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. THREE BALLOON CATHETERS WERE USED, A 3.50MM X 12MM NC EMERGE AND TWO 3.00MM X 15MM NC EMERGE. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT ALL THREE BALLOONS RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8901291 ↗
• InjuryJun 10, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. TWO NON-BSC GUIDE WIRES IN USED IN A PROCEDURE TOGETHER WITH A 3.50MM X 12MM NC EMERGE BALLOON CATHETER FOR POST-DILATION. AFTER INFLATING FOR 21 SECONDS, A LEAK WAS NOTED EMANATING FROM THE GUIDE. THE DEVICE WAS WITHDRAWN; HOWEVER, THE SHAFT BROKE WHICH LEFT THE BALLOON IN THE PROXIMAL LAD. SNARING THE DETACHED PART WAS ATTEMPTED BUT FAILED. FINALLY, ANOTHER BALLOON WAS ADVANCED AND INFLATED AT 5 ATMOSPHERES, TRAPPING THE SEPARATED SHAFT AND SUCCESSFULLY REMOVING FROM THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT WAS NOT HARMED. IT WAS FURTHER REPORTED THAT AFTER THE SHAFT BROKE, THE PATIENT EXPERIENCED CHEST PAIN BUT DID NOT HAVE ANY ST-T WAVE ABNORMALITIES OR HEMODYNAMIC ISSUES.

  Patient problems: Chest Pain; No Consequences Or Impact To Patient

  MAUDE report 8685523 ↗
• MalfunctionJun 10, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50MM X 12MM NC EMERGE BALLOON CATHETER WAS USED DURING A BIFURCATION STENTING. HOWEVER, THE OPERATOR KINKED THE CATHETER AND WHEN THE DEVICE WAS RE-INSERTED INTO THE TOUHY, THE SHAFT FRACTURED. A 3.50MM X 12MM EMERGE WAS ALSO USED AT SOME POINT DURING THE PROCEDURE. HOWEVER, IT WAS ALSO NOTED THAT THE CATHETER GOT FRACTURED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8684064 ↗
• MalfunctionMay 17, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY WAS ENCOUNTERED. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.50 MM X 12 MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, FOLLOWING BALLOON DILATATION, IT WAS NOTED THAT THE DEVICE COULD NOT RETRACT SMOOTHLY. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8619861 ↗
• MalfunctionMay 1, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 3.9MM X 2 TARGET LESION WAS LOCATED IN THE NON TORTUOUS MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INSERTION, THE SHAFT BROKE AT THE RAPID EXCHANGE PORT. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER BALLOON AND COMPLETED THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8570679 ↗