Emerge™ H7493918915200Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 08714729806196), received between Sep 28, 2018 and Aug 16, 2026 — classified as 1 death, 2 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Break” (22 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-0577-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2026Break; Nonstandard Device; Difficult to Remove; Device-Device Incompatibility

  It was reported that removal difficulties and shaft break occurred.The patient presented with a thrombus in the saphenous vein graft (SVG) to the diagonal artery and underwent percutaneous coronary intervention. The origin of the SVG was difficult to cannulate, and the vessel was moderately tortuous without calcification. The thrombus was described as severe and required thrombectomy with a non-Boston Scientific (BSC) thrombectomy device. A 2.00mm X 15mm Emerge balloon catheter was used to block a branch from thrombus while tissue plasminogen activator was being delivered through a non-BSC guide extension catheter. A non-BSC guide catheter was used and was not coaxial to the SVG ostium. Although a lot of push was required, the balloon was delivered to the intended branch and inflated. During withdrawal, the distal shaft broke and the device appeared to be stuck within the non-BSC guide catheter/non-BSC guide extension catheter. The device was in two pieces but was removed together with the non-BSC guide catheter and non-BSC guide extension catheter. There were no patient complications, and the patient outcome was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50263549 ↗
• MalfunctionApr 30, 2026Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON CATHETER BROKE PRIOR TO REACHING THE LESION. THE BALLOON WAS REMOVED AND COMPLETED THE PROCEDURE WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25044653 ↗
• MalfunctionJan 30, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITH NO FRAGMENTS LEFT INSIDE THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219879 ↗
• MalfunctionJul 28, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING THE PROCEDURE, A 2.00MM X 15MM EMERGE? BALLOON CATHETER WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTICED THAT A FEW CENTIMETERS FROM THE SHEATH, THE DELIVERY SHAFT WAS FOUND BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITHOUT ANY PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631008 ↗
• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE SHAFT OF THE BALLOON WAS FRACTURED. THE BALLOON WAS RECOVERED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21929201 ↗
• MalfunctionDec 3, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A FROZEN GUIDEWIRE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT CORONARY ARTERY. A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING WITHDRAWAL, THE GUIDEWIRE BECAME STUCK. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT REMAINED STABLE. IT WAS FURTHER REPORTED THAT THE DEVICE COULD NOT BE REMOVED NORMALLY DUE TO RESISTANCE AND WAS REMOVED THROUGH VARIOUS ATTEMPTED METHODS. IT WAS FURTHER REPORTED THAT THE DEVICE WAS SIMPLY REMOVED AS A WHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20834800 ↗
• MalfunctionOct 18, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE PASSAGE WAS POOR, AND THE BALLOON WAS STUCK. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20486982 ↗
• InjuryFeb 27, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT PERFORATION AND CHEST PAIN OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE MIDDLE RIGHT CORONARY ARTERY (RCA). A 2.00MM X 15MM FG EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING MULTIPLE INFLATION OF THE DEVICE IT RESULTED IN A SMALL PERFORATION IN THE RIGHT CORONARY ARTERY (RCA). THE BALLOON WAS LEFT REINFLATED FOR 10 MINUTES, THEN A NON-BOSTON SCIENTIFIC DEVICE WAS USED TO COVER THE STENT AND WAS QUICKLY ADVANCED AND INFLATED. FOLLOWING STENT DEPLOYMENT, A SYNERGY XD STENT WAS PLACED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND POST-DILATED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT EXPERIENCES SOME CHEST PAIN BUT NEVER HEMODYNAMICALLY UNSTABLE BECAUSE OF THE PERFORATION OF ROTABLATOR ATHERECTOMY AND BALLOON DILATATION OF RIGHT CORONARY ARTERY (RCA), POST-PROCEDURE THE PATIENT STATUS WAS HEMODYNAMICALLY STABLE.

  Patient problems: Chest Pain; Perforation; Restenosis

  MAUDE report 18788487 ↗
• MalfunctionNov 13, 2023Break; Entrapment of Device; Material Integrity Problem; Break; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND TOTALLY OCCLUDED RIGHT CORONARY ARTERY. A 2.00 MM X 15 MM EMERGE WAS ADVANCED TO THE LESION SITE AND SUCCESSFULLY INFLATED AT 12 ATM FOR 8 SECONDS. AFTER FULL DEFLATION AND REMOVAL OF THE DEVICE FROM THE BODY, THE BALLOON WAS NOTED TO BE STUCK ON THE NON-BOSTON SCIENTIFIC GUIDEWIRE. THE PHYSICIAN TRIED TO FORCEFULLY REMOVE THE BALLOON FROM THE GUIDEWIRE AND THE SHAFT DETACHED FROM THE BALLOON. THE GUIDEWIRE WAS CUT IN ORDER TO REMOVE THE DEVICE AND THE BALLOON WAS DESCRIBED AS SEVERELY MANGLED. A MICROCATHETER AND ADDITIONAL WIRE WERE ADVANCED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18124830 ↗
• MalfunctionJul 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED CORONARY ARTERY. A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A ANOTHER EMERGE BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17287283 ↗
• MalfunctionJun 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS 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 17213443 ↗
• MalfunctionJun 21, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY BLOCKAGE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. THE DEVICE CAME OUT COMPLETELY WITHOUT ISSUE. HOWEVER, AFTER REMOVING IT FROM THE BODY, THE MID-POINT OF THE METAL HYPOTUBE BROKE. THE PROCEDURE WAS COMPLETED WITH 2.5 X 15 EMERGE BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17172055 ↗
• MalfunctionJun 16, 2023Material Rupture

  MIDDLE-AGED MALE WITH HISTORY OF CAD (CORONARY ARTERY DISEASE) AND POSITIVE STRESS TEST. PROCEDURE: CARDIAC CATHETERIZATION, ANGIOPLASTY AND STENTING OF LAD (LEFT ANTERIOR DESCENDING ARTERY). WHILE PERFORMING THE ANGIOPLASTY, THE BALLOON RUPTURED. DEVICE REMOVED WITHOUT KNOWN HARM TO PATIENT AND ANOTHER BALLOON USED SUCCESSFULLY. MANUFACTURER RESPONSE FOR CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS, EMERGE (PER SITE REPORTER): WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17142977 ↗
• MalfunctionFeb 8, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE TARGET LESION WAS LOCATED IN LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS SELECTED FOR DILATATION. HOWEVER, DURING PREPARATION, A BALLOON PINHOLE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16326175 ↗
• DeathNov 21, 2022Break; Difficult to Remove; Material Rupture; Break; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2021, AN INDEX PROCEDURE WAS PERFORMED AND IMPLANTED TWO SYNERGY XD DRUG-ELUTING STENTS (DES) AND TWO SYNERGY MEGATRON DES IN THE OSTIAL LEFT MAIN ARTERY (LM), OSTIAL TO PROXIMAL CIRCUMFLEX ARTERY (CX), MID LEFT ANTERIOR DESCENDING ARTERY (LAD), AND OSTIAL TO PROXIMAL FIRST DIAGONAL ARTERY (DIAG1). A CHRONIC TOTAL OCCLUSION WAS DOCUMENTED IN THE RIGHT CORONARY ARTERY (RCA). IN (B)(6) 2022, THE PHYSICIAN ATTEMPTED TO TREAT THE RESTENOSIS FOUND IN THE OSTIAL CX. IT WAS BELIEVED THAT THE STENTS IMPLANTED IN THE OSTIAL CX AND LM WERE NOT FULLY EXPANDED DURING THE INDEX PROCEDURE WHICH LED TO THE UNINTENTIONAL PASSING OF GUIDEWIRES THROUGH THESE UNOPPOSED STENT STRUTS. A 2.00 X 15MM EMERGE BALLOON CATHETER WAS ADVANCED TO THE LM AND INTO THE CX WHERE IT WAS INFLATED TO 10 ATMOSPHERES (ATM), BUT THE BALLOON RUPTURED. THE PHYSICIAN ATTEMPTED TO REMOVE THE 2.00 X 15MM EMERGE BUT A SIGNIFICANT RESISTANCE WAS ENCOUNTERED. THE BALLOON GOT STUCK IN THE VESSEL AND WHEN AN EXTREME FORCE WAS APPLIED TO REMOVE THE DEVICE, THE DISTAL HALF OF THE BALLOON FRACTURED AND REMAINED STUCK IN THE LM AND CX. IN ORDER TO TRAP AND RECOVER THE DISTAL SHAFT OF TH

  Patient problems: Foreign Body In Patient

  MAUDE report 15837835 ↗
• MalfunctionNov 16, 2022Break; Break

  IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED. A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, THE CATHETER BROKE BEFORE GOING INTO THE BODY. THE PHYSICIAN PULLED A NEW DEVICE, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15803971 ↗
• MalfunctionAug 12, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT ON GUIDEWIRE OCCURRED. A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON WAS STUCK ON A 0.014 NON-BOSTON SCIENTIFIC GUIDEWIRE. THE BALLOON COULD NOT BE REMOVED FROM THE WIRE ONCE OUTSIDE THE PATIENT AND HAD TO USED WIRE CUTTER TO CUT OFF THE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON CATHETER AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15218308 ↗
• MalfunctionAug 5, 2022Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01-AUG-2022. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE PATIENT PRESENTED WITH CORONARY HEART DISEASE. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION, HOWEVER, THE SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15178414 ↗
• MalfunctionMay 7, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING WITHDRAWAL, THE SHAFT WAS FRACTURED. THE REMAINING PART WAS REMOVED BY A GUIDEWIRE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14324621 ↗
• MalfunctionMay 7, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE SHAFT WAS FRACTURED. THE DEVICE WAS PULLED OUT WITHOUT ANY OTHER INTERVENTIONS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14324611 ↗
• MalfunctionMay 7, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY. HOWEVER, DURING PREPARATION, THE DEVICE SHAFT FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14324433 ↗
• MalfunctionFeb 17, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.00MM X 15MM EMERGE BALLOON CATHETER ADVANCED FOR DILATATION. HOWEVER, DURING INTRODUCTION, THE SHAFT BROKE AND WAS NOT ABLE TO ENTER THE PATIENT'S BODY. THE FRACTURE PART WAS REMOVED BY PULLING IT TOGETHER WITH THE GUIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13550349 ↗
• MalfunctionJan 24, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED, 2MMX28MM WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13336738 ↗
• InjuryDec 30, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED VIA MEDWATCH MW5105145 THAT BALLOON DETACHMENT OCCURRED, REQUIRING SURGERY FOR REMOVAL VASCULAR PRESENTED FOR LEFT HEART CATHETERIZATION VIA THE RIGHT RADIAL ARTERY. DISEASE WAS NOTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE DIAGONAL BRANCH. THE PHYSICIAN BALLOONED THE LAD FIVE TIMES WITH A 2.00MM X 20MM EMERGE PUSH BALLOON. THE 2.5MM X 15MM EMERGE BALLOON WAS ADVANCED WITHOUT DIFFICULTY, NO EXCESS FORCE WAS NOTED BUT WHILE MOVING INTO THE DIAGONAL, THE BALLOON DETACHED IN THE ARTERY. AN ATTEMPT WAS MADE TO SNARE THE BALLOON BUT IT WAS UNSUCCESSFUL. THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON IN THE GUIDE IN ORDER TO REMOVE THE DETACHED BALLOON BUT THIS WAS ALSO UNSUCCESSFUL. INADVERTENTLY THE 2.00 X 20MM EMERGE PUSH BALLOON DETACHED IN THE GUIDE IN THE RIGHT ARM. THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND AN INTRA-AORTIC BALLOON PUMP WAS INSERTED IN RIGHT FEMORAL ARTERY. THE PATIENT RECEIVED TWO STENTS TO THE MID LAD AND A VENTRICULAR ASSIST DEVICE WAS INSERTED AND THEN REMOVED. THE PATIENT WAS TRANSPORTED TO A HIGHER LEVEL OF CARE FOR URGENT RETRIEVAL OF THE BALLOONS. THE PATIENT UNDERWENT VASCULAR SURGERY AND BOTH BALLOONS WERE RETRIEVED.

  Patient problems: Hematoma

  MAUDE report 13122357 ↗
• MalfunctionJul 2, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THERE WAS ABOUT 80% STENOSIS IN THE MIDDLE OF LEFT ANTERIOR DESCENDING ARTERY (LAD), 50% STENOSIS IN PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) AND 70% STENOSIS IN DISTAL LCX AND 50% STENOSIS IN PROXIMAL RIGHT CORONARY ARTERY. AFTER A NON-BSC GUIDEWIRE CROSSED THE LESION AT THE DISTAL END OF LAD, PRE-DILATATION WAS PERFORMED WITH A 2.00MM X 15MM EMERGE BALLOON CATHETER. HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR 7 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12112631 ↗