Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter C2IVL2512Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00195451000089), received between Jul 13, 2021 and Aug 27, 2025 — classified as 6 deaths, 10 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2025Difficult to Advance; Difficult to Advance

  A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LEFT ANTERIOR DESCENDING ARTERY (LAD). IT WAS REPORTED THAT THE CATHETER WAS UNABLE TO REACH THE LESION IN THE LAD. PRE-DILATION WAS PERFORMED USING PRE-EXTENSION AND POST-EXTENSION TECHNIQUES, AND ACCESS WAS GAINED VIA THE RADIAL ARTERY AND NO RESISTANCE WAS ENCOUNTERED WHILE TRACKING THE CATHETER OVER THE GUIDEWIRE. ANGIOGRAPHY REVEALED A SEVERE DISSECTION AT THE OPENING OF THE LAD FOLLOWING IVL CATHETER RETRACTION. THE PROCEDURE WAS ABORTED AND SUCCESSFULLY COMPLETED USING AN ALTERNATIVE METHOD, WITH NO KINKS OR BALLOON DAMAGE OBSERVED DURING THE PROCESS. THE PATIENT, WITH NO PRE-EXISTING CONDITIONS, WAS TREATED FOR A GRADE C DISSECTION, WHICH WAS MANAGED BY TRANSFER TO SURGERY WITH A CORONARY ARTERY BYPASS GRAFT WITH NO FURTHER COMPLICATIONS.

  Patient problems: Vascular Dissection

  MAUDE report 22909476 ↗
• DeathJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT, AN 80 YEAR OLD FEMALE, HAD TOTAL OCCLUSION IN THE RIGHT CORONARY ARTERY (RCA), HIGHLY CALCIFIED DIFFUSE STENOSIS IN THE LEFT MAIN TRUNK (LMT) TO THE LEFT ANTERIOR DESCENDING ARTERY (LAD), IN THE LAD DISTAL, AND IN THE OSTIUM (OS) OF THE CIRCUMFLEX ARTERY (CX). THE PATIENT WAS INTUBATED PRIOR TO THE PROCEDURE DUE TO BAD RESPIRATORY STATUS, AND THE PATIENT HAD A BLOOD PRESSURE READING BELOW 100. ABIOMED IMPELLA WAS INSERTED PRIOR TO THE TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE DUE TO THE EXTREME EMERGENCY SITUATION. AN ATTEMPT WAS MADE TO TREAT THE HIGHLY CALCIFIED LESION IN THE LEFT CIRCUMFLEX ARTERY (LCX) USING THE BOSTON SCIENTIFIC ROTABLATOR 1.5 MM USING A 6 FR EBU 3.75 SHEATH, BUT IT COULD NOT CROSS THE MAIN LESION DIAMETER (MLD). HOWEVER, A BOSTON SCIENTIFIC ROTABLATOR 1.25 MM WAS ABLE TO CROSS THE LESION. ANOTHER 7FR EBU 3.75 SHEATH WAS IN PLACE FOR AN ADDITIONAL GUIDEWIRE, LIKELY TO MINIMIZE THE NEED TO SWAP SHEATHS THEY ALREADY HAD IT IN PLACE WITH A BACK UP DOUBLE-GUIDEWIRE (GW). FOLLOWING THIS, INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED TO ASSESS THE CONDITION OF THE VESSEL. A CALCIFICATION 3+ WAS OBSERVED DURING THE IVUS ASSESSMENT. TO AVOI

  Patient problems: Cardiac Tamponade; Perforation of Vessels

  MAUDE report 22612808 ↗
• MalfunctionJun 2, 2025Material Rupture

  CARDIAC CATHETERIZATION COMPLICATED BY LITHOTRIPSY BALLOON RUPTURE RESULTING IN DISSECTION BACK INTO LEFT MAIN AND LEFT CIRCUMFLEX REQUIRING STENTING OF THE LEFT MAIN INTO THE LAD [LEFT ANTERIOR DESCENDING] AND CULOTTE STENTING OF THE PROXIMAL LEFT CIRCUMFLEX FINISHED WITH KISSING BALLOONS.

  Patient problems: Aortic dissection

  MAUDE report 22122580 ↗
• DeathApr 26, 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 LEFT ANTERIOR DESCENDING ARTERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, FOLLOWED BY STENTING. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY. IN THAT SAME AFTERNOON, THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AGAIN WITH CARDIOPULMONARY ARREST (CPA). IMAGES SHOWED THAT THE LAD STENT WAS OCCLUDED AND IN A STATE OF SPONTANEOUS AWAKENING TRIALS (SAT). AFTER THE CPA URGENT PROCEDURE WAS CONDUCTED, A LEFT VENTRICULAR (LV) RUPTURE AND PERICARDIAL FLUID OCCURRED. THE PATIENT EXPIRED THAT NIGHT. THE PHYSICIAN DID NOT DENY THE CAUSAL RELATIONSHIP COMPLETELY BETWEEN IVL AND THE PATIENT'S DEATH BUT ALSO THINKS OTHER FACTORS MAY BE MORE SIGNIFICANT. LESION #6 WAS TREATED WITH THE IVL CATHETER AND STENT. LESION #7 WAS TREATED WITH A BALLOON CATHETER (BC) AND STENT. ABOUT 75 % STENOSIS REMAINED DISTAL TO THE STENT IN LESION #7. HOWEVER, THE 75 % STENOSIS WAS VERY TINY, SO THE PHYSICIAN DECIDED NOT TO TREAT THE SITE AND LEFT IT AS IT WAS. THE PHYSICIAN BELIEVES THIS MIGHT HAVE BEEN RELATED TO THE EVENT.

  Patient problems: Cardiac Arrest; Pericardial Effusion

  MAUDE report 19198169 ↗
• InjuryMar 18, 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 DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE TO TREAT A LESION LOCATED IN THE LEFT CIRCUMFLEX (CFX). PERI-PROCEDURE, THE PATIENT WAS PROVIDED 7000 UNITS OF HEPARIN. THE IVL BALLOON SUCCESSFULLY DELIVERED 30 PULSES WITH NO MALFUNCTION OF THE DEVICE REPORTED. TWENTY-THREE MINUTES (23) AFTER THE COMPLETION OF THE INDEX PROCEDURE, THE PATIENT REPORTED CHEST PAIN. THE PATIENT WAS SENT BACK FOR IMAGING AND A CORONARY THROMBUS WAS NOTED IN THE NON-TARGET LESION. THE PATIENT UNDERWENT A SECOND PCI (REVASCULARIZATION) ON THE SAME DAY. DURING A SECOND PCI REVASCULARIZATION PROCEDURE, THERE WAS BLEEDING IN THE LEFT GROIN AND PATIENT'S SYSTOLIC BLOOD PRESSURE (SBP) WAS AT 80MMHG. THE PATIENT WAS PROVIDED ATROPINE DELIVERED INTRAVENOUSLY (IV), GIVEN REGLAN FOR NAUSEA, NOREPINEPHRINE INFUSION, AND ONE UNIT OF PACKED RED BLOOD CELLS (PRBC). THEN AN ULTRASOUND WAS PERFORMED, AND THE PATIENT WAS NEGATIVE FOR PSEUDOANEURYSM. AFTER MONITORING, THE PATIENT WAS SUBSEQUENTLY DISCHARGED TO HOME. FOLLOWING CLINICAL EVENTS COMMITTEE (CEC) ADJUDICATION OF THIS EVENT, IT WAS NOTED THAT THE THROMBUS IN THE LESION WAS DUE

  Patient problems: Angina; Hematoma; Thrombosis/Thrombus

  MAUDE report 18924408 ↗
• MalfunctionDec 13, 2023Difficult to Advance; Difficult to Advance

  A PATIENT WITH A 75% OCCLUDED LAD #6 WITH A CALCIFICATION SCORE 4 WAS TREATED VIA PERCUTANEOUS CORONARY INTERVENTION (PCI). USING A 7F GUIDEPLUS GUIDE, PREDILATION OF THE TARGET LESION WAS PERFORMED USING A 2.0 MM NON-COMPLIANT BALLOON (NC) FOLLOWED BY OCT. A 2.5X12MM IVL CATHETER INSERTED INTO THE PATIENT AND ADVANCED UP TO THE TARGET LESION AND WOULD NOT CROSS. THE IVL CATHETER WAS REMOVED, AND PREDILITATION WAS AGAIN PERFORMED USING THE 2.0 MM NC BALLOON AT 12 ATM. THE IVL CATHETER WAS RE-INSERTED INTO THE PATIENT A 2ND TIME, AND THE IVL CATHETER STILL WOULD NOT CROSS THE LESION. THE IVL CATHETER WAS REMOVED, AND THE LESION WAS PREDILATED 2 ADDITIONAL INSTANCES WITH A 2.5 MM NC BALLOON, EACH TIME THE IVL CATHETER WAS REMOVED FROM THE PATIENT AND RE-INSERTED INTO THE PATIENT, STILL UNSUCCESSFUL CROSSING THE LESION. THE GUIDEPLUS WAS PUSHED AGAIN, AND THE IVL STILL WOULD NOT CROSS. THE IVL CATHETER WAS REMOVED FROM THE PATIENT, AND THE GUIDEPLUS GUIDE WAS REPLACED WITH A 6F EZ GUIDE. THE IVL CATHETER WAS AGAIN RE-INSERTED INTO THE PATIENT FOR THE 5TH TIME, AT WHICH TIME THE IVL CATHETER SHAFT WAS OBSERVED TO BE DEFORMED (SHRANK) AROUND THE EXIT PORT. THE IVL CATHETER WAS REMOVED F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18323374 ↗
• DeathNov 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MAJOR CARDIAC DECOMPENSATION UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE USING A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL). ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY WITH A 7F SHEATH. THE IVL PROCEDURE WAS TO TREAT A VERY CALCIFIED LESION LOCATED IN THE CIRCUMFLEX (CX) ARTERY. THE LESION WAS DESCRIBED AS LONG, TORTUOUS, DIFFUSED AND EXTREMELY ANGULATED/ TORTUOUS. THE PHYSICIAN FIRST USED A ROTOBLATOR TO PREPARE THE LESION FOR IVL TREATMENT AND THEN A SUBSEQUENT STENT IMPLANTATION. AFTER THE IVL DELIVERED 20 CYCLES OF PULSES, THE BALLOON RUPTURED. ANOTHER IVL WAS SUCCESSFULLY USED TO TREAT THE CIRCUMFLEX (CX). THE PATIENT ALSO HAS LESIONS IN THE BIFURCATION IN THE LEFT MAIN MEDINA 1,1,1. ACCORDINGLY, THE PHYSICIAN INFLATED THE BIFURCATION USING A 3.0MM BALLOON CATHETER BUT WITH UNDESIRED RESULT. DUE TO THE EFFICACITY, THE PHYSICIAN DECIDED TO INFLATE USING A SHORT NON-COMPLIANT (NC) BALLOON OUTSIDE OF THE CX IN PREPARATION FOR KISSING-STENT TECHNIQUE TO RECONSTRUCT WITH BIFURCATION. THE PHYSICIAN INFLATED THE BALLOON TO 10 ATMS AND IT PERFORATED AND MASSIVELY RUPTURED THE ARTERY AND RESULTED IN PATIENT'S DEATH.

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

  MAUDE report 18209469 ↗
• DeathNov 20, 2023Mechanical Problem; Retraction Problem; Unintended Movement; Mechanical Problem; Retraction Problem; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURE TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. ACCESS TO THE LESION WAS OBTAINED VIA RIGHT FEMORAL WITH A 7 FR. CORDIS AVANTI SHEATH. AFTER THE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER DELIVERED 70 PULSES, THE PHYSICIAN ATTEMPTED TO REMOVE THE IVL CATHETER, A RESISTANCE WAS FELT WITHIN THE MEDTRONIC LAUNCHER EBU3.75 GUIDING CATHETER. REPORTEDLY, THE IVL WAS A LITTLE BULKY TO REMOVE, BECAUSE OF THE HIGHER CROSSING PROFILE, SO THERE WAS MORE FORCE NEEDED TO REMOVE IT. WHILE THE IVL WAS BEING REMOVED, THE GUIDING CATHETER MOVED MORE INTO THE LEFT MAIN (LM) THUS CREATING ARTERIAL DISSECTION. THE DISSECTION WAS SUCCESSFULLY TREATED WITH STENT IMPLANTATION. IT WAS CONFIRMED THAT THE GUIDING CATHETER DID NOT BREAK. WHEN THE IVL CATHETER WAS REMOVED, IT WAS OBSERVED THAT THERE WAS BLOOD INSIDE THE INDEFLATOR, AN INDICATION THAT THE BALLOON HAD RUPTURED. WHILE STILL ON THE TABLE, THE PATIENT STARTED TO DETERIORATE AND EXHIBITED LOW BLOOD PRESSURE TO FULL STOP OF PRESSURE. THE PATIENT WAS REANIMATED WITH A LUCAS-CPR (MECHANICAL CHEST COMPRESSION DEVICE) AN

  Patient problems: Cardiogenic Shock; Low Cardiac Output; Vascular Dissection

  MAUDE report 18170061 ↗
• InjuryOct 4, 2023Partial Blockage; Material Rupture; Partial Blockage; Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE USING A SHOCKWAVE C2 CORONARY INTRAVASCULAR (IVL) CATHETER IN THE # 7 BRANCH OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD), THE IVL BALLOON DELIVERED 10 PULSES. DURING THE 2ND CYCLE, THE BALLOON DELIVERED 7 PULSES. HOWEVER, THE BALLOON WAS FLUOROSCOPICALLY OBSERVED THAT THE PRESSURE WAS DECREASING, AND THE BALLOON WAS SIMULTANEOUSLY DIMINISHING IN SIZE. DURING IMAGING, A LEAKAGE FROM THE SAME TARGET VESSEL (LAD) WAS NOTED UNDER FLUOROSCOPY SO THE PHYSICIAN IMMEDIATELY PLACED A PAPYRUS COVERED STENT TO TAMPONADE THE LEAK. POST IVL TREATMENT, FULL AND PATENT HEMOSTASIS WAS ACHIEVED. THEN THE PHYSICIAN TREATED THE DISTAL TO PROXIMAL LESION IN THE #6 BRANCH OF THE LAD. DURING THE USE OF THE IVL CATHETER, IT WAS OBSERVED THAT THERE WAS A SLOW FLOW AND THROMBOSIS WAS NOTED AT THE SITE OF THE PAPYRUS STENT THAT WAS PLACED IN THE #7 BRANCH. IT WAS ALSO NOTED THAT THE PROXIMAL PART OF THE STENT WAS NOT A PRECISE CIRCLE. THE PHYSICIAN ASPIRATED THE THROMBUS AND PERFORMED LONG INFLATIONS USING A PERFUSION BALLOON CATHETER. THEN A BIOFREEDOM DRUG-COATED CORONARY STENT (DES) WAS IMPLANTED IN THE #6 BRANCH. THE INTENDED PROCEDURE WAS COMPLETED WITH NO ADDIT

  Patient problems: Perforation of Vessels; Thrombosis/Thrombus

  MAUDE report 17871176 ↗
• MalfunctionSep 27, 2023Material Rupture; Material Rupture

  A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) BALLOON WAS USED TO TREAT A DE NOVO LESION IN THE CORONARY ARTERY. AFTER DELIVERING 30 PULSES, A BALLOON LOSS OF PRESSURE OCCURRED. POST IVL TREATMENT, INTRAVASCULAR ULTRASOUND (IVUS) WAS INITIATED TO VIEW THE LESION. AN IMAGE OF A FOREIGN PARTICLE WAS OBSERVED IN IVUS WHICH THE PHYSICIAN SUSPECTED IT TO BE AN IVL MATERIAL THAT BROKE OFF.. ANOTHER IVL WAS PREPPED AND USED TO SUCCESSFULLY COMPLETE THE INTENDED PROCEDURE. ANOTHER IVUS IMAGING WAS TAKEN AFTER THE USE OF THE SECOND DEVICE. IT WAS REPORTED THAT THE FOREIGN PARTICLE APPEARED TO BE ON A DIFFERENT SITE FROM THE FIRST IMAGE THAT WAS TAKEN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17826173 ↗
• MalfunctionSep 19, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE TO TREAT A CALCIFIED DE NOVO LESION LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. PRIOR TO THE PROCEDURE, THE LESION WAS PRE-DILATED MULTIPLES TIMES USING A 2.0MM AND 2.5MM NON-COMPLIANT (NC) BALLOONS AT 12 ATMS. AN OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS TAKEN POST DILATATION TO TAKE IMAGES OF THE TARGET VESSEL. THEN THE PHYSICIAN ATTEMPTED TO ADVANCE A SHOCKWAVE C2 CORONARY INTRAVASCULAR (ILV) CATHETER TOWARDS THE LESION USING A 7F GUIDEPLUS¿ GUIDE EXTENSION CATHETER). HOWEVER, THE IVL WAS UNABLE TO CROSS THE LESION. THE IVL WAS REMOVED FROM THE PATIENT AND THE GUIDEPLUS¿ (GUIDE EXTENSION CATHETER) CATHETER WAS REPLACED WITH A 6F EASYGUIDE (EXTENSION CATHETER). THE IVL WAS SUCCESSFULLY INSERTED HOWEVER, IT WAS OBSERVED THAT THE CATHETER SHAFT WAS DEFORMED AROUND THE EXIT PORT. THE DEFORMED IVL WAS REPLACED WITH ANOTHER IVL CATHETER, BUT THE BALLOON WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN DECIDED TO TREAT THE CALCIFICATION PROXIMAL TO THE LESION, SO HE PULLED THE GUIDE EXTENSION BACK AND KEPT THE IVL CATHETER IN THE SAME POSITION. WHILE PULLING OUT THE GUIDE EXTENSION, IT BROKE OFF. THE IVL CATHETER WAS USED TO RETR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17777153 ↗
• DeathAug 9, 2023Difficult to Remove; Material Separation; Detachment of Device or Device Component; Difficult to Remove; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION LOCATED IN THE CORONARY ARTERIES. IT WAS REPORTED THAT WHEN THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE IVL CATHETER, IT GOT STUCK IN THE LESION. WHEN THE PHYSICIAN TRIED TO REMOVE THE MEDTRONIC 6F TELESCOPE GUIDE EXTENSION, THE SHAFT OF THE CATHETER SEPARATED. ALL ATTEMPTS TO SNARE THE BROKEN PIECE WERE UNSUCCESSFUL. THE PATIENT WAS SENT TO THE OPERATING ROOM (OR) TO SURGICALLY REMOVE THE FRAGMENT HOWEVER, THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17492004 ↗
• InjuryJun 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY CATHETER WAS USED TO TREAT A LESION IN THE #7 BRANCH OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS SEVERELY CALCIFIED (360 DEGREES, 90% OCCLUDED, 10MM LONG LESION). THE PATIENT SHOWED DISCOMFORT AND HIS BLOOD PRESSURE DECREASED TO 50 MMHG DURING PRE-DILATATION WAS PERFORMED AND BEFORE THE INITIAL INSERTION OF THE IVL CATHETER. THE PATIENT'S CONDITION AND BLOOD PRESSURE RECOVERED WHEN THE PRE-DILATION WAS COMPLETED. REPORTEDLY, AFTER THE FIRST BALLOON INFLATION AT 4 ATM, NO PULSE COULD BE DELIVERED, AND ERROR 88 WAS DISPLAYED. THE IVL CATHETER WAS REMOVED FROM THE PATIENT'S BODY WHERE THE PHYSICIAN WAS ABLE TO DELIVER A PULSE OUTSIDE. THE IVL CATHETER WAS THEN REINSERTED BACK INTO THE PATIENT AND RE-INFLATED. A BALLOON RUPTURE OCCURRED AND THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VFIB). NO DRUG WAS USED DURING THE PROCEDURE BEFORE VFIB. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). AS OF THIS DATE, IT IS UNKNOWN IF THE PATIENT HAS BEEN DISCHARGED HOME. ACCORDING TO THE REP, THE PHYSICIAN BELIEVES THAT THE IVL CATHETER HAS NO RELATIONSHIP TO THE REPORTED ADVERSE EVENT. THE P

  Patient problems: Ventricular Fibrillation

  MAUDE report 17243419 ↗
• InjuryMay 1, 2023Intermittent Energy Output; Intermittent Energy Output

  IT WAS REPORTED THAT AN IN-PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A LESION IN THE LEFT MAIN (LM) CORONARY ARTERY. DURING THE INITIAL USE OF THE SHOCKWAVE C2 INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER, THE BALLOON DELIVERED 10 PULSES AND THEN THE GENERATOR DISPLAYED ERROR 88. A SECOND IVL WAS PREPPED AND USED, DELIVERED 18 PULSES. HOWEVER, THE SAME ERROR OCCURRED. FOUR DAYS FOLLOWING THE IVL TREATMENT, THE PATIENT EXPERIENCED ACUTE SEVERE CHEST PAIN WHICH SUBSEQUENTLY CAUSED THE TREATED LEFT MAIN TO CLOSE ABRUPTLY. THE PHYSICIAN PERFORMED A SECOND PCI TO OPEN THE LEFT MAIN. IT WAS REPORTED THAT THE CALCIUM WASN'T FULLY EXPANDED BECAUSE OF INCOMPLETE EXPANSION AND DUE TO INADEQUATE CALCIUM MODIFICATION. THE PHYSICIAN SUCCESSFULLY TREATED THE CLOSED VESSEL WITH STENT IMPLANTATION AND POST DILATATION OF THE VESSEL USING A NON-COMPLIANT (NC) BALLOON. THREE DAYS LATER, THE PATIENT SUFFERED A SECOND ABRUPT VESSEL CLOSURE. TO DATE, THERE HAVE BEEN NO UPDATES ON THE STATUS OF THE PATIENT.

  Patient problems: Chest Pain; Restenosis

  MAUDE report 16844958 ↗
• InjuryMar 30, 2023Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  THE PATIENT PRESENTED AT THE HOSPITAL DUE TO A NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) WITH RESTENOSIS FROM A PRIOR STENT PLACEMENT IN THE LEFT MAIN (LM) CORONARY ARTERY AND CIRCUMFLEX ARTERY (CX). PRIOR TO THE PROCEDURE, THE LM LESION WAS PRE-DILATED WITH A 2.5 X 12MM NON-COMPLIANT (NC) BALLOON USING LOW PRESSURES. AN INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED CONFIRMING SIGNIFICANT CALCIUM IN THE OSTIAL CX AND NEO INTIMAL HYPERPLASIA IN THE LM. THE PHYSICIAN ELECTED TO TREAT THE CX ONLY BY USING A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER, WHICH IS OUTSIDE THE INDICATIONS FOR USE FOR THE CORONARY IVL CATHETER AS IT IS INDICATED FOR USE IN DE NOVO CORONARY ARTERIES. IT WAS NOTED THAT THERE WAS NO OTHER TREATMENT OPTION FOR THE PATIENT. AFTER A SUCCESSFUL DELIVERY OF 60 PULSES, THE IVL BALLOON RUPTURED. AFTER THE DEVICE WAS REMOVED, AN ANGIOGRAM WAS PERFORMED SHOWING A NOTABLE SLOW FLOW IN THE CX AND THE DISTAL OBTUSE MARGINAL (OM) BRANCHES COULD NOT BE VISUALIZED. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) WAS REPORTED TO BE AROUND 300 SECS AND PATIENT BECAME HYPOTENSIVE AND EXPERIENCED BRADYCARDIA (SLOW HEART RATE). A CARDIOPULMONARY RESUSCITATION

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension

  MAUDE report 16645982 ↗
• MalfunctionMar 24, 2023Material Rupture

  BALLOON RUPTURED WHEN INFLATED DURING HEART CATHETERIZATION CAUSING INJURY TO PATIENT'S CORONARY ARTERY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16618502 ↗
• InjurySep 19, 2022Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) BALLOON WAS USED IN A PATIENT WHO UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A CHRONIC UNDER-EXPANDED STENT WITH CONCENTRIC CALCIUM IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PRE-DILATED WITH A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) NON-COMPLIANT (NC) BALLOON. ACCESS TO THE TARGET LESION WAS OBTAINED VIA FEMORAL APPROACH. WHEN THE IVL CATHETER WAS CONNECTED TO THE GENERATOR, THE BALLOON WAS PRESSURIZED TO 4 ATMS AND WITH THE 1ST PUSH OF THE BUTTON ON THE CONNECTOR CABLE, ERROR 88 WAS DISPLAYED. AFTER THE STAFF CLEARED THE ERROR, THE BALLOON WAS ABLE TO DELIVER A FULL 20 PULSES BEFORE IT RUPTURED. IMMEDIATELY, THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VFIB). THE PATIENT WAS "SHOCKED" OR DEFIBRILLATED WITH A DEFIBRILLATOR AND THE PATIENT WAS CONVERTED BACK TO INTRINSIC NORMAL SINUS RHYTHM (NSR). AFTER THE PATIENT WAS DEFIBRILLATED, NO OTHER INTERVENTION WAS NEEDED TO TREAT THE VFIB. THE PATIENT WAS DISCHARGED TO HOME THE FOLLOWING DAY WITH NO CLINICAL SEQUELAE.

  Patient problems: Arrhythmia; Ventricular Fibrillation

  MAUDE report 15451724 ↗
• DeathMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) BALLOON WAS USED IN A PATIENT WHO UNDERWENT A HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A HIGHLY CALCIFIED DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE IVL BALLOON SUCCESSFULLY DELIVERED 80 PULSES. POST IVL, THE TARGET LESION WAS DILATED WITH A NON-COMPLIANT (NC) BALLOON TO ENLARGE THE OPENING AND FURTHER EXPANDED WITH A DRUG-ELUTING STENT (DES) USING A KISS-POT (PROXIMAL OPTIMIZATION TECHNIQUE) ACROSS THE OSTIAL CIRCUMFLEX. THE LEFT MAIN CORONARY ARTERY (LMCA) WAS ALSO DISEASED AND ONCE STENTED WITH A MEDICATED STENT, VISUALIZATION OF THE STENTS WAS SEEN TO BE WIDELY OPEN. AT THIS TIME, THE PATIENT DEVELOPED HYPOTENSION (BP DROPPED TO 67/43 MMHG) AND HEARBEAT RATE OF 48 AND CONTINUED TO DECLINE. THE PATIENT'S LEVEL OF CONSCIOUSNESS (LOC) WAS IMPAIRED, AND THE OXYGEN LEVEL SATURATION (DESATS) WAS UNDETECTABLE. THE PATIENT WENT INTO ELECTROMECHANICAL DISSOCIATION (EMD). THE PATIENT WAS GIVEN EPINEPHRINE BOLUSES, CARDIOPULMONARY RESUSCITATION (CPR), CARDIOVERSION AND INTUBATION HOWEVER, THE PATIENT CODED AND SUBSEQUENTLY EXPIRED.

  Patient problems: Cardiogenic Shock; Low Blood Pressure/ Hypotension

  MAUDE report 14497899 ↗
• MalfunctionFeb 22, 2022Activation Failure

  CATHETER WAS UNDEPLOYABLE ONCE INSERTED INTO THE CORONARY ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13577625 ↗
• InjuryJan 25, 2022Use of Device Problem; Deformation Due to Compressive Stress; Difficult to Advance; Use of Device Problem; Deformation Due to Compressive Stress; Difficult to Advance

  A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) BALLOON WAS USED IN A PATIENT WHO HAS A CHRONIC CORONARY SYNDROME THREE-VESSEL DISEASE (3VD) AND A LEFT VENTRICLE (LV) FUNCTIONING AT ONLY 15-20%. THE DE NOVO LESION LOCATED AT THE RIGHT CORONARY ARTERY (RCA) WAS PRE-DILATED MULTIPLE TIMES USING 1.0, 2.0 AND 2.5MM NON-COMPLIANT (NC) BALLOONS (THE LATTER TWO). ANGIOGRAM AND OPTICAL COHERENCE TOMOGRAPHY (OCT) SHOWED A SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). THERE WERE NO PRE-EXISTING STENTS AT THE VICINITY OF THE TARGET LESION. RESISTANCE WAS ENCOUNTERED WHILE ATTEMPTING TO CROSS THE PROXIMAL/MID LAD WITH THE FIRST IVL BALLOON, AND THE CATHETER SHAFT BROKE OUTSIDE THE PATIENT'S ANATOMY, PRIOR TO DELIVERY OF ANY PULSES. A SECOND IVL BALLOON WAS INSERTED INTO THE PATIENT HOWEVER, IT WAS ALSO UNABLE TO CROSS THE LESION. THE PHYSICIAN APPLIED FORCE TO CROSS THE LESION AND IT RENDERED THE IVL SHAFT TO BEND/KINK AT THE LEVEL OF THE GUIDE EXIT WHICH WAS INSIDE THE PATIENT. THE BEND/KINK CAUSED CESSATION OF BLOOD FLOW IN THE LAD. THE PATIENT WAS IMMEDIATELY PROVIDED 2X1MG ADRENALIN AND 10 MINUTES OF MECHANICAL ASSIST DEVICE (IMPELLA HEART PUMP). ONCE THE PATIENT REGAIN

  Patient problems: Cardiac Arrest

  MAUDE report 13347202 ↗
• InjuryJan 18, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  C2 BALLOON DETACHMENT AND SUCCESSFUL RETRIEVAL. HEAVILY CALCIFIED RCA UNDER ANGIOGRAPHY. A SHOCKWAVE CORONARY C2 INTRAVASCULAR LITHOTRIPSY (IVL) DEVICE WAS USED TO TREAT THE RIGHT CORONARY ARTERY (RCA). USING A 6F SYSTEM, THE PHYSICIAN OBTAINED ACCESS TO THE RCA AND PERFORMED MULTIPLE BALLOON INFLATIONS THROUGHOUT THE LESION SEGMENT. A 6F GUIDELINER WAS ADVANCED WITHIN THE RCA TO ADVANCE THE 2.5 X 12 IVL CATHETER TO THE SEGMENTED LESION OF 18-20MM. THE IVL BALLOON WAS INFLATED TO 4ATMS AND SEVERAL TREATMENTS PERFORMED (PULSES USED UNKNOWN). DURING ADVANCING OR INFLATION OF THE IVL DEVICE, THE 6F GUIDE-LINER WAS PULLED BACK INTO THE GUIDE DUE TO PATIENT PRESSURE DAMPENING. UPON COMPLETION OF IVL THERAPY, RESISTANCE WAS ENCOUNTERED UPON ATTEMPTS TO WITHDRAWAL THE IVL CATHETER. AFTER SEVERAL ATTEMPTS TO PULL BACK AND REMOVE THE IVL CATHETER, THE BALLOON SEGMENT OF THE CATHETER SEPARATED FROM THE SHAFT, LEAVING THE BALLOON ON THE WIRE IN THE DISTAL RCA. A SECOND WIRE WAS ADVANCED ALONG WITH A BALLOON, AND THE BALLOON WAS INFLATED TO CONTAIN THE DETACHED IVL CATHETER SEGMENT, AND THE ENTIRE SYSTEM, INCLUDING THE DETACHED COMPONENT, WAS SUCCESSFULLY REMOVED AS A UNIT, IN WHICH CAUSED LOS

  Patient problems: Vascular Dissection

  MAUDE report 13280753 ↗
• InjuryDec 14, 2021Material Deformation; Material Deformation

  A SHOCKWAVE C2 CORONARY LITHOTRIPSY (IVL) DEVICE WAS USED ON A PATIENT WHO UNDERWENT A CHRONIC TOTAL OCCLUSION (CTO) PROCEDURE AT THE RIGHT CORONARY ARTERY (RCA). ACCESS WAS OBTAINED VIA FEMORAL ARTERY. ANGIOGRAPHY REVEALED A SHELF OF PROXIMAL NODULAR CALCIFICATION AND NO PRE-EXISTING STENT WAS AT THE TARGET VESSEL. THE VESSEL WAS PRE-DILATED MULTIPLE TIMES WITH BOTH NON-COMPLIANT AND COMPLIANT BALLOONS. REPORTEDLY, THE PHYSICIAN FELT A LOT OF RESISTANCE WHILE ADVANCING THE CATHETER THROUGH THE SHAFT TO THE TARGET VESSEL. AFTER THE IVL BALLOON DELIVERED 10 PULSES, AT WHICH TIME THE SHAFT WAS OBSERVED TO BE KINKED. THE SHAFT DID NOT SEPARATE SO THE PHYSICIAN WAS ABLE TO PULL OUT THE KINKED CATHETER WITH SOME RESISTANCE. A SECOND IVL BALLOON CATHETER WAS USED, AND THE SHAFT EXPERIENCED THE SAME RESISTANCE, AND GOT STUCK IN THE GUIDING CATHETER ON THE OFF-RAMP OF THE GUIDE EXTENSION. THE PHYSICIAN REMOVED IT BY PULLING THE ENTIRE GUIDING CATHETER OUT. IT WAS THEN NOTED UNDER FLUOROSCOPY THAT THERE WAS A DISSECTION AT THE DISTAL END OF THE RCA. THE VESSEL WAS VERY CALCIFIED AND THE IVL BALLOON WAS UNABLE TO PASS THROUGH THIS SECTION. ACCORDING TO THE FIELD CLINICAL SPECIALIST (FCS), TH

  Patient problems: Vascular Dissection

  MAUDE report 13002439 ↗
• MalfunctionJul 13, 2021Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  A SHOCKWAVE C2 CORONARY LITHOTRIPSY (IVL) DEVICE WAS SUCCESSFULLY USED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN ATTEMPTED TO OPEN THE LAD LESION USING A NON-COMPLIANT (NC) BALLOON WITHOUT SUCCESS. THE C2 CATHETER WAS PREPPED AND INSERTED INTO THE PATIENT. FOLLOWING BALLOON INFLATION AND INITIATION OF IVL, THE BALLOON LOST PRESSURE AFTER 3 PULSES. THE BALLOON WAS DEFLATED AND ATTEMPTS TO REMOVE THE BALLOON WERE UNSUCCESSFUL, LEAVING A PORTION OF THE BALLOON JAILED AGAINST THE VESSEL WALL. HALF OF BALLOON REMAINED ATTACHED ON THE VESSEL WALL, AND THE PHYSICIAN WAS UNABLE TO RECROSS THE LESION WITH THE GUIDEWIRE AND ELECTED TO CONVERT THE PATIENT TO SURGICAL BYPASS. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

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

  MAUDE report 12161041 ↗