Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter C2IVL3012Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00195451000096), received between Sep 21, 2021 and Jan 22, 2026 — classified as 4 deaths, 18 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (6 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• DeathJan 22, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED DURING AN EMERGENCY PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH IMPELLA CIRCULATORY SUPPORT PROCEDURE TO TREAT A PATIENT THAT WENT INTO CARDIOGENIC SHOCK DUE TO SEVERE AORTIC STENOSIS. ANGIOGRAPHY IDENTIFIED CHRONIC TOTAL OCCLUSIONS OF THE RIGHT CORONARY ARTERY (RCA) AND LEFT CIRCUMFLEX ARTERY WITH CIRCUMFERENTIAL, HEAVILY CALCIFIED LESIONS. TWO (2) SHOCKWAVE C2 IVL CATHETERS WERE ADVANCED UNDER GUIDE EXTENSION CATHETER SUPPORT TO ATTEMPT LESION MODIFICATION, HOWEVER, BOTH IVL CATHETERS RUPTURED DURING USE. THE FIRST IVL CATHETER BALLOON RUPTURED AFTER 10 PULSES AND THE SECOND IVL CATHETER (MDR#: 3015053858-2026-00006) RUPTURED AFTER 20 PULSES; A THIRD IVL CATHETER (MDR#: 3015053858-2026-00007) DELIVERED 40 PULSES TO ACHIEVE DILATATION AND COMPLETE THE PROCEDURE. POST[?]IVL IMAGING REVEALED MULTIPLE CRACKS IN THE TREATED SEGMENT. A KIZASHI CUTTING BALLOON WAS THEN INFLATED TO 20 ATM, AT WHICH TIME A VESSEL PERFORATION WAS OBSERVED. A PAPYRUS COVERED STENT WAS DEPLOYED FOR HEMOSTASIS BUT FRACTURED, SO AN ADDITIONAL OVERLAPPING COVERED STENT WAS PLACED, WHERE SUCCESSFUL HEMOSTASIS WAS ACH

  Patient problems: Perforation of Vessels

  MAUDE report 24141930 ↗
• InjuryJul 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). DURING THE PROCEDURE, THE IVL BALLOON RUPTURED AT 4 ATM AFTER 18 PULSES, LEADING TO A TYPE 2 VESSEL PERFORATION EVIDENT ON ANGIOGRAPHY. AS INTERVENTION, A RYUSEI 3.0 MM PERFUSION BALLOON CATHETER WAS DILATED FOR 10 MINUTES, ACHIEVING SUCCESSFUL HEMOSTASIS BEFORE PLACING A PK PAPYRUS 2.5 MM BALLOON. HOWEVER, A LATERAL BRANCH OCCLUSION WAS OBSERVED, LEADING TO ATTEMPTS TO WIRE THE LATERAL BRANCH. UNFORTUNATELY, VENTRICULAR FIBRILLATION (VF) OCCURRED DURING THIS PROCESS, REQUIRING DIRECT CURRENT (DC) CARDIOVERSION FOR STABILIZATION. THE WIRING WAS SUCCESSFULLY COMPLETED, RESULTING IN IMPROVED BLOOD FLOW AND BLOOD PRESSURE. NOTABLY, THE CALCIFICATION WAS 270 DEGREES LONG AND 15 MM WIDE, WITH NO CORONARY NECROSIS NOTED. INTRAVENOUS ULTRASOUND (IVUS) SHOWED PERFORATION AT THE EDGE OF THE CALCIFICATION AND AT A NON-CALCIFIED SITE. THE PATIENT WAS A 78-YEAR-OLD MALE PATIENT, MEDICAL HISTORY INCLUDES AN OLD MYOCARDIAL INFARCTION TREATED WITH A DRUG-COATED BALLOON IN (B)(6) 2021, DYSLIPIDEMIA, AND GASTROESOPHAGEAL REFLUX DISEASE. THE PATIENT WAS DISCHARGED

  Patient problems: Arrhythmia; Perforation of Vessels; Ventricular Fibrillation

  MAUDE report 22544386 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT WAS REPORTED TO SHOCKWAVE VIA THE POST MARKET EMPOWER CAD CLINICAL STUDY. A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THERE WERE 30 PULSES SUCCESSFULLY DELIVERED AT 4 ATM. A STENT WAS SUCCESSFULLY PLACED. THERE WAS NO IVL MALFUNCTION REPORTED. A MYOCARDIAL INFARCTION (MI) OCCURRED ON THE SAME DAY AS THE INDEX PROCEDURE, AFTER THE PROCEDURE AND PRIOR TO DISCHARGE. THE PATIENT WAS ADMINISTERED PRASUGREL AND ASPIRIN WITH POSITIVE EFFECTS. TROPONIN LEVELS NORMALIZED WITHOUT ADDITIONAL INTERVENTION, AND THE PATIENT WAS DISCHARGED TWO DAYS LATER. THIS EVENT WAS ADJUDICATED BY THE CLINICAL EVENTS COMMITTEE (CEC) WHICH CONFIRMED A NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) WAS ATTRIBUTABLE TO THE TARGET VESSEL. IT WAS DETERMINED THAT THE MI WAS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE.

  Patient problems: Myocardial Infarction

  MAUDE report 21407644 ↗
• InjuryNov 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETERS WERE USED TO TREAT A LESION IN THE CORONARY ARTERIES. THIS REPORT IS FOR THE FIRST CATHETER USED IN THE PROCEDURE. REFER TO MDR# 3015053858-2024-00131 FOR THE SECOND CATHETER. BOTH CATHETERS SUCCESSFULLY DELIVERED 80 PULSES AT 4 ATM. DURING THE DELIVERY OF THE IVL CATHETER TO THE LESION, NO ISSUES WERE OBSERVED AT THE TREATMENT SITE, BUT HEMATOMA WAS OBSERVED AT A DISTANT SITE. A 3.0MM XIENCE STENT WAS IMPLANTED FOLLOWING IVL TREATMENT. UPON POST-DILATION OF THE STENT USING A 4.5MM NC BALLOON, A VESSEL RUPTURE OCCURRED. THE PHYSICIAN STATED THAT THE VESSEL WAS HIGHLY CALCIFIED, AND THE DIAMETER OF THE NC BALLOON WAS TOO LARGE. HEMOSTASIS WAS ATTEMPTED WITH A RYUSEI BALLOON CATHETER AND COVERED STENT BUT WAS UNSUCCESSFUL, SO THE PATIENT WAS TRANSFERRED TO SURGERY. A CORONARY ARTERY BYPASS GRAFT (CABG) WAS PERFORMED ALONGSIDE AN AORTIC STENOSIS (AS) AND AORTA ASCENDENS (AA) REPLACEMENT OPERATION. THE SURGERY WAS COMPLETED WITH NO ISSUES AND THE PATIENT IS CURRENTLY STABLE AND HOSPITALIZED IN THE ICU. THE PHYSICIAN STATED THAT IVL COULD BE AN INDIRECT CAUSE OF THE VESSEL PERFORATION, BUT IT IS UNKNOWN AND UNLIKELY. TH

  Patient problems: Perforation of Vessels

  MAUDE report 20776506 ↗
• InjurySep 25, 2024Failure to Cycle; Failure to Cycle

  A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERIES. AFTER 20 PULSES WERE DELIVERED AT 4 ATM, ERROR 88 OCCURRED. NO-REFLOW AND ST ELEVATION WAS FLUOROSCOPICALLY OBSERVED AT LESION #6 FROM JUST PROXIMAL TO DISTAL. AFTER A THROMBUS ASPIRATION CATHETER WAS USED, A 2.5 BALLOON CATHETER (BC) WAS INFLATED, AND BLOOD FLOW WAS OBSERVED. A 2.5 X 26 MM STENT AND A 3.0 X 26 MM STENT WERE PLACED AT LESION#7 AND LESION #6. THE FLOW WAS IMPROVED TO THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI)2 (SLOW FLOW) AND THE PROCEDURE WAS COMPLETED. AFTER THE PROCEDURE, THE CREATINE KINASE (CK) VALUE INCREASED TO 2000 BUT THEN IMPROVED. THE PATIENT UNDERWENT ADDITIONAL HOSPITALIZATION TO IMPROVE BLOOD FLOW AND WAS DISCHARGED FROM THE HOSPITAL A FEW DAYS AFTER THE INDEX PROCEDURE. THE PHYSICIAN BELIEVES THERE IS A CASUAL RELATIONSHIP BETWEEN IVL AND ST ELEVATION.

  Patient problems: Myocardial Infarction; Reduced Blood Flow

  MAUDE report 20306103 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE CORONARY ARTERIES. THERE WAS NO IVL DEVICE MALFUNCTION REPORTED. MYOCARDIAL INFARCTION OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A ROTABLATOR AND IVL FOLLOWED BY DRUG-ELUTING STENT (DES) PLACEMENT. DURING THE USE OF THE ROTABLATOR, SLOW-FLOW TEMPORARILY OCCURRED BECAUSE OF SLIGHT DISTAL EMBOLIZATION, WHICH RECOVERED AFTER INTRACORONARY INJECTION OF NICORANDIL. SLIGHT ELEVATED CARDIAC ENZYMES WERE OBSERVED AND BECAME PERIOPERATIVE NON-Q-WAVE MYOCARDIAL INFARCTION (NON-QMI) BUT THE PATIENT RECOVERED WITH NO ISSUE. THE PHYSICIAN COMMENTED THAT THERE IS NO CAUSAL RELATIONSHIP BETWEEN THE EVENT AND IVL. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AS PLANNED WITH NO EXTENSION OF HOSPITALIZATION.

  Patient problems: Embolism/Embolus; Myocardial Infarction

  MAUDE report 20233651 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN IMAGING CASE REPORT WAS PUBLISHED ON J-STAGE BY THE JAPANESE CORONARY ASSOCIATION (DOI: 10.7793/JCAD.30.24-00011). CATASTROPHIC ELLIS TYPE III CORONARY PERFORATION FROM A HIGH-PRESSURE SCORING BALLOON POST INTRAVASCULAR LITHOTRIPSY (IVL) THERAPY WAS REPORTED IN A CASE THAT OCCURRED IN JAPAN. FOLLOWING THE USE OF A 3.0MM IVL, THE PATIENT UNDERWENT DILATION WITH A 3.0MM SCORING BALLOON CATHETER AT 20 ATM WITHOUT PRIOR IMAGING, RESULTING IN VASCULAR PERFORATION. THE PATIENT ALSO EXPERIENCED HEMODYNAMIC COLLAPSE IN WHICH THE PHYSICIAN PROMPTLY ESTABLISHED VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION. A COVERED STENT WAS SUCCESSFULLY DEPLOYED. APPROXIMATELY 400 ML OF BLOODY PERICARDIAL FLUID WAS DRAINED BY PERICARDIOCENTESIS, AND THE CARDIAC TAMPONADE WAS RESOLVED. FINAL ANGIOGRAPHY DEMONSTRATED COMPLETE HEMOSTASIS OF THE RUPTURED VESSEL, AND THE PATIENT WAS DISCHARGED AFTER CARDIAC REHABILITATION WITHOUT ANY SEQUELAE. THE PHYSICIAN DOES NOT BELIEVE THE C2 CATHETER CAUSED THE VASCULAR PERFORATION. THERE WAS NO IVL DEVICE MALFUNCTION REPORTED.

  Patient problems: Cardiac Tamponade; Hemodynamic instability; Perforation of Vessels

  MAUDE report 20153120 ↗
• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  A SHOCKWAVE C2 CORONARY INTRAVASCULAR (IVL) LITHOTRIPSY CATHETER WAS USED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERIES. THE IVL BALLOON RUPTURED DURING THE SECOND CYCLE, RESULTING IN LOSS OF PRESSURE. BLOOD WAS NOTED AT THE END OF THE CATHETER WHERE IT WAS CONNECTED TO THE PRESSURE PUMP. A NEW IVL CATHETER WAS USED AND DURING CATHETER DELIVERY, IT WAS OBSERVED THAT THE PATIENT'S BLOOD VESSELS WERE RUPTURED BY THE ABRASION OF SHARP CALCIFIED NODULES. THE PROCEDURE WAS COMPLETED AFTER A STENT WAS PLACED. THE PATIENT'S CURRENT STATUS IS UNKNOWN. THIS REPORT IS FOR THE SECOND CATHETER USED IN THE PROCEDURE. PLEASE REFER TO MDR# (B)(4) FOR THE FIRST CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation of Vessels

  MAUDE report 19833637 ↗
• InjuryJul 25, 2024No Apparent Adverse Event; Material Split, Cut or Torn; No Apparent Adverse Event; Material Split, Cut or Torn

  A SHOCKWAVE C2 CORONARY INTRAVASCULAR (IVL) LITHOTRIPSY CATHETER WAS USED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERIES. THE IVL BALLOON RUPTURED DURING THE SECOND CYCLE, RESULTING IN LOSS OF PRESSURE. BLOOD WAS NOTED AT THE END OF THE CATHETER WHERE IT WAS CONNECTED TO THE PRESSURE PUMP. A NEW IVL CATHETER WAS USED AND DURING CATHETER DELIVERY, IT WAS OBSERVED THAT THE PATIENT'S BLOOD VESSELS WERE RUPTURED BY THE ABRASION OF SHARP CALCIFIED NODULES. THE PROCEDURE WAS COMPLETED AFTER A STENT WAS PLACED. THE PATIENT'S CURRENT STATUS IS UNKNOWN. THIS REPORT IS FOR THE FIRST CATHETER USED IN THE PROCEDURE. PLEASE REFER TO MDR# 3015053858-2024-00079 FOR THE SECOND CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation of Vessels

  MAUDE report 19833635 ↗
• DeathApr 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  TWO SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETERS WERE USED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PATIENT HAD A HISTORY OF CORONARY ARTERY DISEASE, CHRONIC KIDNEY DISEASE, HYPERTENSION, HYPERLIPEMIA, TYPE 2 DIABETES, PARKINSON'S DISEASE, HYPOTHYROIDISM, GASTROESOPHAGEAL REFLUX DISEASE, AND LEFT TEMPLE BASAL CELL CARCINOMA. THE VESSEL WAS PRE-DILITATED WITH COMPLIANT BALLOON, FOLLOWED BY ADDITIONAL PRE-DILITATION WITH TWO NON-COMPLIANT BALLOONS. THE PHYSICIAN ATTEMPTED TO PASS AN IVUS THROUGH THE LESION BUT WAS UNSUCCESSFUL. A C2 IVL CATHETER WAS ADVANCED AND ABLE TO CROSS THE LESION AND DELIVERED 40 PULSES AT 4-6 ATMOSPHERES BEFORE THE BALLOON LOST PRESSURE . THE PHYSICIAN STATED THAT THE BALLOON LOSS OF PRESSURE WAS DUE TO SIGNIFICANT CALCIUM. A SECOND C2 IVL CATHETER WAS INTRODUCED INTO THE PATIENT AND ADVANCED TO THE PROXIMAL LAD WHERE ADDITIONAL IVL PULSES WERE DELIVERED AND THE PATIENT DEVELOPED HYPOTENSION. THE PATIENT WAS TREATED WITH LEVOPHED AND PHENYLEPHRINE. THE PROCEDURE CONTINUED WITH THE SECOND C2 IVL CATHETER SUCCESSFULLY DELIVERING THE DESIRED NUMBER OF PULSES. THE PATIENT EXPERIENCED ASYSTOLE AND CPR WAS INITIATED

  Patient problems: Asystole; Low Blood Pressure/ Hypotension

  MAUDE report 19140847 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT THE LEFT MAIN (LM) AND THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A KISSING BALLOON TECHNIQUE WAS UTILIZED FOR THE PROCEDURE. ACCESS TO THE TARGET VESSEL(S) WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY (RFA). THE IVL CATHETER WAS INSERTED INTO THE PATIENT WITH A 7F GUIDE CATHETER. THE IVL CATHETER SUCCESSFULLY DELIVERED 80 PULSES WITH POST DILATION WITH A 3.5 BALLOON CATHETER TO THE LM AND LAD. A 3.5 × 12MM XIENCE SKYPOINT STENT WAS IMPLANTED TO THE LM AND A 2.25 X 15MM RESOLUTE ONYX STENT WAS IMPLANTED IN THE LAD. A STENT MALPOSITION WAS OBSERVED AND A 5.0 BALLOON CATHETER WAS UTILIZED TO DILATE THE STENT AT THE PROXIMAL SITE. A CORONARY PERFORATION OCCURRED AT LEFT MAIN TRIFURCATION (LMT) DISTAL. DURING IVUS IMAGING, IT WAS OBSERVED THAT THERE WAS A HEMATOMA AT THE PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX). THE HEMATOMA CAUSED A SLOW FLOW. THE PHYSICIAN IMPLANTED A HEMOSTASIS STENT (COVERED STENT) TO COMPLETE THE PROCEDURE. THE PATIENT WAS DISCHARGED FOUR DAYS POST PROCEDURE. THERE WAS NO SHOCKWAVE DEVICE PROBLEM REPORTED WITH THE ADVERSE EVENT.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 18660965 ↗
• InjuryJan 30, 2024Entrapment of Device; Off-Label Use; Difficult to Remove; Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn; Entrapment of Device; Off-Label Use; Difficult to Remove; Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn

  A C2 CORONARY IVL CATHETER WAS USED TO TREAT THE LEFT ANTERIOR DESCENDING ARTERY (LAD). ACCESS TO THE TARGET LESION WAS OBTAINED VIA THE RADIAL ARTERY. THE IVL BALLOON DELIVERED 30 PULSES INSIDE A PRE-EXISTING STENT. UPON REMOVAL OF THE IVL CATHETER, IT BECAME STUCK IN THE VESSEL. THE IVL CATHETER BECAME DETACHED AND THE PHYSICIAN ENCOUNTERED DIFFICULTIES IN REMOVING THE DETACHED COMPONENT. THE PHYSICIAN INSERTED AN IMPELLA VENTRICULAR ASSIST DEVICE. HOWEVER, THE PATIENT'S CARDIAC OUTPUT DECREASED. DURING THIS TIME, THE PATIENT STARTED EXHIBITING SYMPTOMS THAT REQUIRED BEING TRANSFERRED TO THE OPERATING ROOM (OR). THE PATIENT UNDERWENT THORACOTOMY TO RETRIEVE THE DETACHED PORTION OF THE IVL CATHETER AND A CORONARY ARTERY BYPASS GRAFT (CABG) WAS ALSO PERFORMED. IT WAS ALSO REPORTED THAT THE LAD WAS DISSECTED DUE TO THE MANIPULATION OF THE CATHETER TO REMOVE IT. THE PATIENT IS REPORTED TO BE RECOVERING WELL.

  Patient problems: Vascular Dissection

  MAUDE report 18608725 ↗
• InjuryJul 20, 2023Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component; Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, A SHOCKWAVE C2 CORONARY LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). PRIOR TO THE START OF THE PCI, A NON-COMPLIANT (NC) BALLOON WAS USED TO PRE-DILATE THE LESION, HOWEVER, THE BALLOON RUPTURED. THE PHYSICIAN DECIDED TO USE A ROTOBLATOR TO REMOVE THE CALCIUM FROM THE TARGET VESSEL. FOLLOWING A SUCCESSFUL ROTOBLATOR PROCEDURE, THE PHYSICIAN ADVANCED THE SHOCKWAVE C2 CORONARY LITHOTRIPSY (IVL) CATHETER TO THE DISTAL LESION. THE BALLOON SUCCESSFULLY DELIVERED 30 PULSES AND THEN IT WAS RETRACTED BACK TO THE PROXIMAL LESION. HOWEVER, THE BALLOON BECAME ENTRAPPED BY CORONARY CALCIUM DESPITE SEVERAL ROUNDS OF THERAPY AT THE SITE. THE PHYSICIAN ATTEMPTED TO PULL BACK THE BALLOON, PULLED DOUBLE NEGATIVE AND ATTEMPTED TO WIRE AROUND WITHOUT SUCCESS. THE BALLOON WAS INFLATED, AND IT APPEARED TO HAVE DEFORMED AS VISUALLY OBSERVED VIA ANGIOGRAM AND IVUS IMAGING. THE PHYSICIAN CONTINUED TO MANIPULATE THE CATHETER TO REMOVE THE STUCK BALLOON AT WHICH THE BALLOON RUPTURED. THE PHYSICIAN INSERTED A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON NEXT T

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 17366855 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE TO TREAT A CONCENTRIC DE NOVO LESION LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). ACCESS TO THE LESION WAS OBTAINED VIA THE RADIAL ARTERY. A SHOCKWAVE C2 CORONARY LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT THE TARGET LESION. THE PHYSICIAN INTENDED TO TREAT THE PROXIMAL LAD BUT DECIDED TO TREAT THE DISTAL LESION FIRST. AFTER THE IVL BALLOON DELIVERED 60 PULSES, A VESSEL PERFORATION OCCURRED IN THE LAD. THE PHYSICIAN PLACED A CORONARY BALLOON TO MANAGE THE PERFORATION WHILE A GRAFTMASTER¿ RX CORONARY STENT GRAFT SYSTEM WAS PREPARED. THE GRAFTMASTER WAS UNABLE TO TREAT THE PERFORATION. THE PATIENT'S CONDITION DECLINED. THE PATIENT'S BLOOD PRESSURE DROPPED, ELECTROCARDIOGRAM (EKG) CHANGED, AND THE PHYSICIAN HAD TO PERFORM PERICARDIOCENTESIS DUE TO PERICARDIAL EFFUSION AND THEN TRANSFERRED THE PATIENT TO SURGERY FOR A SUCCESSFUL BYPASS. SINCE THE PATIENT WAS ALSO ON SCHEDULE FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR), THE SURGEON ALSO ENDED UP REPLACING THE AORTIC VALVE AND TREATING THE PERFORATION WITH ONE SURGICAL PROCEDURE. THE PATIENT WAS EXTUBATED ON (B)(6) 2023 AND IS

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 17302478 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE TO TREAT A 3-VESSEL DISEASE. THE PATIENT HAD AN RCA (RIGHT CORONARY ARTERY), CFX (CIRCUMFLEX CORONARY ARTERY), AND LAD (LEFT ANTERIOR DESCENDING ARTERY) DISEASED VESSELS. A SHOCKWAVE C2 CORONARY LITHOTRIPSY (IV) CATHETER WAS ONLY USED IN THE LAD AND WAS TREATED LAST. FOLLOWING A SUCCESSFUL IVL TREATMENT, THE PHYSICIAN USED A 3.0MM NON-COMPLIANT (NC) BALLOON FOR POST DILATATION. THE NC BALLOON RUPTURED SO ANOTHER NC BALLOON WAS USED. HOWEVER, EXTRAVASATION WAS OBSERVED OUTSIDE OF THE TARGET VESSEL DUE TO A PERFORATION IN THE ARTERY. THE PHYSICIAN USED COVERED STENTS TO CLOSE THE PERFORATION. IT WAS REPORTED THAT THE PATIENT'S CONDITION STARTED TO DECLINE SO EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), WHICH IS A FORM OF LIFE SUPPORT, WAS PROVIDED. PERICARDIOCENTESIS WAS ALSO PERFORMED TO REMOVE FLUID FROM THE PERICARDIAL SAC. THE PATIENT WAS THEN TAKEN TO THE OPERATING ROOM (OR) BECAUSE BLOOD WAS STILL COMING FROM THE HEART DRAIN AND NOT FROM THE LAD. THIS WAS CONFIRMED VIA ANGIOGRAPHY IMAGING. THE PATIENT IS STILL IN THE HOSPITAL BUT NOW OFF ECMO. THE PATIENT IS REPORTED TO BE NEUROLOGICALL

  Patient problems: Extravasation; Hemorrhage/Blood Loss/Bleeding; Perforation; Pericardial Effusion

  MAUDE report 17221830 ↗
• InjuryJun 26, 2023Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE TO TREAT A LESION LOCATED IN THE #3 BRANCH AND THE DISTAL RIGHT CORONARY ARTERY (RCA). ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. AFTER THE PHYSICIAN POSITIONED THE 6F GUIDEZILLA¿II, THE SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS ADVANCED TOWARDS THE TARGET VESSEL. AFTER THE BALLOON SUCCESSFULLY DELIVERED 70 PULSES IN THE # 3 BRANCH, THE PHYSICIAN ATTEMPTED TO ADVANCE TO THE DISTAL RCA. HOWEVER, THE GUIDE CATHETER ENCOUNTERED A PREVIOUSLY IMPLANTED STENT WHICH IS IN THE #1 BRANCH. THE STENT GOT DEFORMED BY THE GUIDE AND SO THE PHYSICIAN ATTEMPTED TO REMOVE THE IVL CATHETER FROM THE PATIENT, HOWEVER, IT COULD NOT BE PULLED BACK AND GUIDEZILLA SIMULTANEOUSLY GOT STUCK. THE PHYSICIAN USED ANOTHER GUIDE EXTENSION AND A GUIDEWIRE TO BAIL OUT THE STUCK DEVICES BUT WERE UNSUCCESSFUL. THE DEVICES WERE RETRIEVED WITH A BYPASS PROCEDURE. REPORTEDLY, THE PATIENT IS STILL IN THE HOSPITAL AND HAS NOT YET BEEN DISCHARGED AS OF THIS REPORT. ACCORDING TO THE REPORT, THE PHYSICIAN BELIEVES THAT THE GUIDE CATHETER DEFORMED THE STENT WHICH LED TO THE GUIDE EXTENSION GETTING STUCK AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17198728 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO SHOCKWAVE C2IVL CORONARY LITHOTRIPSY (IVL) CATHETERS WERE USED ON THIS PATIENT. REPORTEDLY, POST INDEX PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE FOR THE POST MARKET EMPOWER CAD CLINICAL STUDY, PATIENT # 112, 001 WAS REPORTED TO HAVE EXPERIENCED 9/10 CHEST PAIN RADIATING TO THE RIGHT JAW. CARDIAC ANGIOGRAM SHOWED ST DEPRESSIONS AND THE PATIENT WAS GIVEN NITROGLYCERIN BUT WITHOUT RELIEF. INTRAVENOUS TRINDIL DRIP WAS STARTED AND WHEN THE PATIENT WAS BROUGHT BACK TO THE CATH LAB, THERE WAS A LAB DISSECTION OBSERVED. THE PHYSICIAN TREATED THE DISSECTION WITH RX STENTS X 4. THE PATIENT WAS TRANSFERRED TO THE CARDIOTHORACIC INTENSIVE CARE UNIT (CTICU). TWO DAYS LATER, THE PATIENT WAS REPORTED TO HAVE A HEART FAILURE REDUCED EJECTION FRACTION (EF). IT WAS REPORTED TO HAVE BEEN TREATED WITH MEDICATION. ECHOCARDIOGRAM POST PCI EF WAS 40% (BASELINE WAS 64%), HEART FAILURE CONSULTED. THE PATIENT WAS WARM AND WELL PERFUSED, BUT VOLUME WAS OVERLOADED. PATIENT WAS ADVISED TO CONTINUE CARDIAC MEDICATION (HYDRALAZINE) TO ALLOW FOR INCREASE FLUID REMOVAL. THE PATIENT'S EF WAS ALSO ASSOCIATED WITH ORTHOPNEA (SENSATION OF BREATHLESSNESS).

  Patient problems: Angina; Chest Pain; Myocardial Infarction

  MAUDE report 17195184 ↗
• InjuryFeb 14, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT WHO WAS REPORTED TO BE HAVING CHEST PAIN UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE TO TREAT A CALCIFIED DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. ACCESS TO THE LESION WAS OBTAINED VIA FEMORAL APPROACH. PRIOR TO THE PROCEDURE, THE PATIENT WAS PUT ON HEPARIN AND SEDATION MEDICATIONS. THEN A ROTATIONAL ATHERECTOMY WAS PERFORMED TO HELP BREAK DOWN THE CALCIUM FOLLOWED BY PRE-DILATATION USING A NON-COMPLIANT (NC) ANGIOPLASTY BALLOON. THEN A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) BALLOON WAS ADVANCED TOWARDS THE LESION AND AFTER DELIVERING 40 PULSES ON THE 2ND INFLATION AT 4 ATMS, THE BALLOON WOULD NOT HOLD PRESSURE. THE PHYSICIAN DEFLATED THE BALLOON AND PULLED THE CATHETER BACK TO THE GUIDE CATHETER WHERE IT WAS MET WITH RESISTANCE. AFTER THE IVL WAS REMOVED, IT WAS FOUND THAT HALF OF THE BALLOON MATERIAL WAS MISSING BUT THE REST OF THE CATHETER WAS INTACT. ANGIOGRAM SHOWED THE LAD WAS WITHOUT FLOW AND WIRE ACCESS WAS LOST. THE PHYSICIAN ATTEMPTED TO REWIRE THE NATIVE LAD HOWEVER, IT WAS UNSUCCESSFUL. SINCE THE PATIENT ALREADY HAD A GRAFT TO THE DISTAL LAD DUE TO PREVIOUS MULTIPLE BYPASS SURGERIES, ON

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16376074 ↗
• InjuryNov 23, 2022Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  A SHOCKWAVE CORONARY LITHOTRIPSY CATHETER WAS USED ON A PATIENT WHO UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE TO TREAT A CONCENTRIC DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. ACCESS TO THE LESION WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. PRIOR TO THE PROCEDURE, THE LESION WAS PRE-DILATED WITH A 2.0 X 15MM NON-COMPLIANT (NC) BALLOON. WHEN THE 3.0 X 12MM IVL CATHETER WAS ADVANCED TO THE TARGET VESSEL, THE BALLOON WOULD NOT CROSS THE LESION. THE IVL WAS REMOVED, AND THE LESION WAS PRE-DILATED AGAIN WITH A 2.75 X 20MM NC BALLOON. AFTERWARDS, THE IVL CATHETER WAS RE-INSERTED ALONG WITH A 45CM SHEATH TO USE AS A SUPPORT. THE GUIDEWIRE WAS ALREADY INSERTED INTO THE LAD ARTERY AND THE IVL CATHETER WAS INSERTED OVER THAT WIRE THROUGH THE GUIDE CATHETER. THIS TIME THE IVL BALLOON WAS ABLE TO CROSS AND SUCCESSFULLY DELIVERED 60 PULSES. WHEN THE PHYSICIAN ATTEMPTED TO PULL THE GUIDE CATHETER OUT OF THE LAD, THE GUIDE CATHETER WAS PULLED DEEP INTO THE LEFT MAIN (LM). THIS RESULTED IN A DISSECTION IN THE DISTAL (LM), INTO THE PROXIMAL LAD AND THE CIRCUMFLEX (CX) ARTERIES. THE PCI PROCEDURE WAS NOT ABLE TO BE FULLY COMPLETED DUE TO DISSECTION. THE IVL TREATM

  Patient problems: Vascular Dissection

  MAUDE report 15859001 ↗
• DeathOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A PATIENT HAD A VENTRICULAR HEART PUMP PROCEDURE DUE TO CORONARY ARTERY DISEASE (CAD), THE PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) USING THE SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER TO TREAT A CONCENTRIC DE NOVO LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR CORONARY (LAD) AND CIRCUMFLEX (CX) ARTERIES. THE BALLOON SUCCESSFULLY DELIVERED 40 PULSES IN EACH VESSEL. POST IVL PROCEDURE, A DRUG-ELUTING STENTS (DES) WERE DEPLOYED IN THE LEFT CIRCUMFLEX AND PROXIMAL LAD. THE LAD AND THE CX WERE POST-DILATED WITH NON-COMPLIANT (NC) BALLOONS. FOLLOWING POST-DILATATION AND CONTRAST INJECTION, THE PATIENT'S BLOOD PRESSURE WAS OBSERVED TO BE DROPPING. AFTER FURTHER IMAGING, IT WAS DISCOVERED THAT THE LEFT CX AND THE LEFT MAIN (LM) WERE PERFORATED. COVERED STENTS WERE IMMEDIATELY DEPLOYED TO TREATMENT THE PERFORATIONS. ANGIOGRAPHY SHOWED THE BLEEDING HAD SUBSIDED HOWEVER, DUE TO THE STABILITY OF THE PATIENT, AND THE ECHOGRAM STILL SHOWING BLEEDING, THE PATIENT WAS EMERGENTLY TRANSPORTED TO THE OPERATING ROOM (OR) FOR SURGERY TO STOP THE BLEEDING. AFTER THE SURGERY, THE PATIENT WAS TRANSFERRED BACK TO THE ICU ON IMPELLA SUPPORT A

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 15632396 ↗
• InjuryJul 7, 2022Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  A C2 IVL CORONARY CATHETER WAS USED TO TREAT A HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. FEMORAL ACCESS WAS GAINED AND IVUS WAS USED. PHYSICIAN ALSO USED CSI PRIOR TO THE IVL CATHETER. ONE CYCLE OF SHOCKWAVE IVL PULSES WAS DELIVERED AND THE IVL CATHETER WAS ATTEMPTED TO BE WITHDRAWN FROM THE PATIENT. ATTEMPTS TO REMOVE THE IVL CATHETER WERE UNSUCCESSFUL, AND A PORTION OF THE IVL CATHETER BROKE OFF INSIDE THE PATIENT. IT WAS NOTED THAT THE PHYSICIAN THEN TRIED TO SNARE THE DETACHED CATHETER BUT WAS UNSUCCESSFUL. THE PHYSICIAN STATED THAT THE IVL CATHETER POSSIBLY GOT HUNG UP ON A SHELF OF CALCIUM. NO EXCESSIVE FORCE USED DURING DEVICE REMOVAL/DEVICE MANIPULATION. THE PATIENT WAS SCHEDULED FOR ANOTHER PROCEDURE TO SURGICALLY REMOVE THE DETACHED CATHETER. FOLLOWING THE CASE, THE PATIENT WAS STABLE IN ICU. IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN HEART SURGERY A FEW DAYS FOLLOWING THE IVL PROCEDURE, AND THE IVL CATHETER SUCCESSFULLY REMOVED. PATIENT IS DOING WELL, AND NO ADDITIONAL PATIENT SEQUELAE HAS BEEN REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14949908 ↗
• MalfunctionApr 1, 2022Deflation Problem; Entrapment of Device; Difficult to Remove; Deflation Problem; Entrapment of Device; Difficult to Remove

  A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) BALLOON WAS USED IN A PATIENT WHO UNDERWENT A PROCEDURE TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) AT THE RIGHT CORONARY ARTERY (RCA). ACCESS WAS OBTAINED VIA FEMORAL ARTERY. AFTER 40 PULSES WERE DELIVERED, THE PHYSICIAN DEFLATED THE BALLOON TO PULL IT OUT HOWEVER, THE BALLOON WOULD NOT DEFLATE AND COULD NOT BE REMOVED. THE PHYSICIAN CUT OFF THE HUB OF THE IVL CATHETER AND USED A GUIDE EXTENSION TO HELP REMOVE THE CATHETER. THE BALLOON WAS ABLE TO BE WITHDRAWN AS SOON AS THE GUIDE EXTENSION ADDED ADDITIONAL SUPPORT AND CHANGED THE ANGLE OF THE BALLOON. THE IVL BALLOON CAME OUT INTACT, MINUS THE HUB THAT WAS CUT OFF TO ADVANCE THE GUIDE EXTENSION OVER THE BALLOON. ADDITIONALLY, THE PHYSICIAN BELIEVES THE BALLOON GOT SNAGGED ON CALCIUM. POST IVL, ROTATIONAL ATHERECTOMY WAS PERFORMED AND WAS FOLLOWED WITH DRUG ELUTING STENT (DES) PLACEMENT. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13980799 ↗
• MalfunctionDec 27, 2021Sparking; Sparking

  A SHOCKWAVE C2 CORONARY LITHOTRIPSY (IVL) DEVICE WAS USED TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. DURING THE INITIATION OF THE SHOCKWAVE IVL THERAPY PROCEDURE, FLASHES OF BLUE LIGHT WERE OBSERVED IN THE SHOCKWAVE HUB, IN THE DIRECTION OF THE INDEFLATOR, AND THE ASSISTING NURSE REPORTED RECEIVED ELECTRIC SHOCKS IN HER HAND/FINGERS, WHICH WAS PAINFUL AND CAUSED A NUMB/STRANGE FEELING IN HER FINGERS LASTING FOR 3 HOURS. THE ASSISTING NURSE HAD NO INJURY TO HER FINGERS AND DID NOT REQUIRE ANY TREATMENT AND THE CONDITION OF HER FINGERS WAS REPORTED TO HAVE RESOLVED WITHOUT FURTHER INCIDENT. A NEW IVL CATHETER WAS OPENED AND THE IVL PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Discomfort

  MAUDE report 13089698 ↗
• DeathSep 21, 2021Difficult to Advance; Difficult to Advance

  A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) DEVICE WAS USED TO TREAT AN IN-STENT STENOSIS, WHICH IS OFF-LABEL PER THE DEVICE INSTRUCTIONS FOR USE; HOWEVER, THE PHYSICIAN ELECTED TO PROCEED WITH THE IVL PROCEDURE. THE PHYSICIAN REPORTED THAT THE PATIENT HAD ST ELEVATIONS PRIOR TO IVL TREATMENT, AND MINIMAL WORKING VESSELS, AND THE RIGHT CORONARY ARTERY (RCA) WAS COMPLETELY OCCLUDED. DURING PREPARATION OF THE IVL DEVICE, THE BALLOON WAS INADVERTENTLY EXPANDED RATHER THAN PULLING A NEGATIVE TO DE-AIR THE BALLOON, REQUIRING THE DEVICE TO BE RE-PREPPED AGAIN CORRECTLY. PRE-DILATATION WAS PERFORMED USING A 3.0 NON-COMPLIANT (NC) BALLOON. IT WAS NOTED THAT TO REACH THE LESION, THE IVL BALLOON CATHETER WAS TRACKED THROUGH A PRE-EXISTING STENT, AND A PRE-EXISTING STENT WAS ALSO PRESENT WITHIN THE INTENDED TREATMENT LESION, BUT THE DEVICE WOULD NOT FULLY CROSS TO THE DISTAL END OF THE STENT; THE IVL BALLOON COVERED APPROXIMATELY 1/3 OF THE LESION. 10 PULSES WERE DELIVERED, AND THE BALLOON WAS DEFLATED AND REMOVED FROM THE PATIENT. APPROXIMATELY 10 MINUTES POST IVL TREATMENT, THE PATIENT CODED; AN IMPELLA DEVICE WAS ON STANDBY FOR THE PROCEDURE AND WAS USED TO STABILIZE THE PATIEN

  Patient problems: Myocardial Infarction

  MAUDE report 12505490 ↗