Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter C2PIVL4012Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00195451000034), received between Dec 12, 2023 and May 20, 2026 — classified as 2 deaths, 11 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Detachment of Device or Device Component

  A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE CORONARY ARTERIES. THERE WAS SLIGHT RESISTANCE WHILE ADVANCING THE IVL CATHETER. THE INTENDED PROCEDURE WAS COMPLETED WITH ATHERECTOMY. DURING WITHDRAWAL OF THE IVL CATHETER, THE CATHETER SHAFT FRACTURED AND DETACHED INSIDE THE PATIENT. THE DETACHED FRAGMENT WAS SUCCESSFULLY RETRIEVED AS THE GUIDELINER WAS WITHDRAWN AND ALL DEVICE COMPONENTS WERE REMOVED IN ENTIRETY. THE PATIENT WAS THEN TREATED WITH 2 ROTA BURRS, AND THERE WAS NO PATIENT HARM REPORTED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25232629 ↗
• MalfunctionApr 1, 2026Off-Label Use; Detachment of Device or Device Component; Difficult to Advance

  A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE TIBIOPERONEAL TRUNK ARTERY. THE PHYSICIAN WAS AWARE OF THE OFF-LABEL USE AS THE SHOCKWAVE C2+ IVL CATHETER IS INDICATED FOR LITHOTRIPSY-ENABLED, LOW-PRESSURE BALLOON DILATATION OF SEVERELY CALCIFIED, STENOTIC DE NOVO CORONARY ARTERIES PRIOR TO STENTING. IT WAS REPORTED THAT THE CATHETER WAS DAMAGED DURING USE, RESULTING IN A SEPARATION OF THE CATHETER WHEN THE PHYSICIAN ATTEMPTED TO PULL IT OUT. THE BROKEN SHAFT REMAINED INSIDE THE 5 FR INTRODUCER SHEATH. IT WAS NOT DETERMINED WHETHER THE CATHETER WAS KINKED PRIOR TO USE. THE PHYSICIAN BELIEVES THE CATHETER MOST LIKELY DAMAGED DURING ADVANCEMENT, AS HE REPORTED SIGNIFICANT RESISTANCE WHILE ADVANCING THE CATHETER AND NOTED DIFFICULTY POSITIONING THE BALLOON AT THE INTENDED LOCATION. THE BREAK WAS ESTIMATED TO HAVE OCCURRED IN THE MID TO DISTAL SHAFT, WITH THE CATHETER STILL INSIDE THE INTRODUCER SHEATH AT THE POINT OF FAILURE. THE BROKEN CATHETER WAS SNARED AND REMOVED, RESULTING IN ADDITIONAL PROCEDURE TIME, ALTHOUGH IT DID NOT IMPACT OR CHANGE THE PROCEDURE PERFORMED FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT ISSUES, AND N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24760741 ↗
• DeathFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  THIS EVENT WAS REPORTED TO SHOCKWAVE VIA THE POST MARKET EMPOWER CAD CLINICAL STUDY. ON (B)(6) 2024, A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE DISTAL LEFT MAIN CORONARY ARTERY. THE PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE FOR TREATMENT FOR NON-ST ELEVATION ACUTE CORONARY SYNDROME (NSTE-ACS). THE TARGET LESION WAS ACCESSED WITH A 6 FRENCH GUIDE CATHETER (6F) VIA THE FEMORAL ARTERY AND WAS PRE-DILATED WITH A NON-COMPLIANT (NC) BALLOON, FOLLOWED BY THE DELIVERY OF 120 IVL PULSES AT 4 ATMOSPHERES OF PRESSURE (ATM). A STENT WAS SUBSEQUENTLY IMPLANTED, WITH POST-DILATION USING AN ADDITIONAL NC BALLOON. THE PATIENT WAS DISCHARGED ONE DAY AFTER THE INDEX PROCEDURE. NO IVL DEVICE MALFUNCTION OCCURRED DURING THE PROCEDURE. ON (B)(6) 2024, APPROXIMATELY 40 DAYS AFTER THE INDEX PROCEDURE, IT WAS REPORTED THAT THE PATIENT DIED AT HOME FROM A HEART ATTACK. NO ADDITIONAL INFORMATION WAS PROVIDED. THE CLINICAL STUDY SITE DETERMINED THAT THE DEATH WAS POSSIBLY RELATED TO THE STUDY DEVICE AND PROCEDURE.

  Patient problems: Myocardial Infarction

  MAUDE report 24397590 ↗
• MalfunctionDec 17, 2025Off-Label Use; Difficult to Remove; Failure to Advance; Detachment of Device or Device Component; Off-Label Use; Difficult to Remove; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED DURING A PROCEDURE TO TREAT A PATIENT'S AORTA. THE IVL CATHETER WAS PREPARED SUCCESSFULLY. WHEN THE IVL BALLOON WAS ADVANCED TOWARD THE AORTIC BI-FEMORAL GRAFT, IT WOULD NOT ADVANCE THROUGH A PRE-EXISTING STENT. THE LESION WAS LOCATED AT THE PROXIMAL STENT SEGMENT WITHIN THE GRAFT ANASTOMOSIS. THE BALLOON BECAME STUCK AT THE DISTAL STENT SEGMENT AND COULD NOT BE ADVANCED TO THE LESION. DURING ATTEMPTED REMOVAL, THE IVL BALLOON AND CATHETER BROKE APART FROM THE SHAFT AT APPROXIMATELY ONE-THIRD OF THE DISTAL LENGTH. THE PHYSICIAN WAS ABLE TO SNARE AND RETRIEVE THE ENTIRE DISTAL CATHETER AND BALLOON INTACT. IT WAS REPORTED THAT THERE WAS NO BALLOON RUPTURE OR LOSS OF PRESSURE BEFORE THE DEVICE BECAME DIFFICULT TO REMOVE, AND THE BALLOON HAD BEEN FULLY DEFLATED PRIOR TO THE REMOVAL ATTEMPT. THERE WAS NO REPORT OF ANY PATIENT HARM THAT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23835066 ↗
• InjuryNov 15, 2025Adverse 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 OSTIUM OF THE RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT DURING THE THIRD PULSE CYCLE THE PATIENT DEVELOPED VENTRICULAR FIBRILLATION (VF) REQUIRING CARDIOVERSION. AFTER STABILIZATION, THE TEAM ELECTED TO STOP IVL AND SWITCHED TO A SCORING BALLOON AND NON-COMPLIANT (NC) BALLOON, RESULTING IN A SUB-OPTIMAL OUTCOME. THE PATIENT IS CURRENTLY DOING WELL.

  Patient problems: Ventricular Fibrillation

  MAUDE report 23563451 ↗
• InjuryNov 13, 2025Failure to Cycle; Failure to Cycle

  A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). A TOTAL OF 60 IVL PULSES WERE DELIVERED BEFORE AN ERROR 88 OCCURRED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. A ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) WAS REPORTED, BUT IT IS UNKNOWN WHEN IT OCCURRED AND HOW IT WAS TREATED. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Myocardial Infarction

  MAUDE report 23550297 ↗
• InjuryAug 6, 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 CORONARY ARTERY. DURING THE PROCEDURE, 30 PULSES WERE DELIVERED PRIOR TO THE IVL BALLOON LOSING PRESSURE. THE PHYSICIAN SUBSEQUENTLY REMOVED THE IVL DEVICE AND PROCEEDED WITH A NON-COMPLIANT (NC) BALLOON. THE PATIENT EXPERIENCED CARDIAC ARREST AND WAS RESUSCITATED WITH CPR. FOLLOWING THE IVL TREATMENT, THE ARTERY WAS PERFORATED BY THE STENT. A COVERED STENT WAS SUCCESSFULLY IMPLANTED TO ADDRESS THE PERFORATION. THE PATIENT WAS STABILIZED AND TRANSFERRED TO THE ICU.

  Patient problems: Cardiac Arrest; Perforation of Vessels

  MAUDE report 22729051 ↗
• InjuryJun 19, 2025Adverse 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. 120 IVL PULSES WERE SUCCESSFULLY DELIVERED. IT WAS REPORTED THAT THERE WAS A PERFORATION OF A LARGE NODULAR CALCIUM. TO STOP THE BLEEDING, THE PHYSICIAN DEPLOYED A 4.0 X15 ABBOTT TREK BALLOON ACROSS THE AREA AT LOW PRESSURE TO TEMPORARILY STOP EXTRAVASATION WHILE THE TEAM OBTAINED A COVERED STENT. THE TREK BALLOON WAS THEN REMOVED AND A 3.5X15 BIOTRONIK PAPYRUS STENT WAS IMPLANTED ACROSS THE AREA AND POST DILATED WITH A 3.5 X15 ABBOTT TREK NC BALLOON. A FOLLOW-UP ANGIOGRAM REVEALED COMPLETE RESOLUTION OF THE EXTRAVASATION. ADDITIONALLY, A FOLLOW-UP ECHOCARDIOGRAM REVEALED A 1.5 CM "SMALL" AREA OF EFFUSION IN THE PERICARDIAL SPACE. THE DOCTOR THEN INSERTED A PERICARDIAL DRAIN AND DRAINED A TOTAL OF 150ML OF BLOOD OVERNIGHT. THE PERICARDIAL DRAIN WAS REMOVED 2 DAYS LATER. THE PATIENT WAS DISCHARGED THE FOLLOWING WEEKEND. THE PHYSICIAN NOTED THAT PATIENT'S SLOW RECOVERY WAS A RESULT OF HIS COMORBID STATUS (HEART FAILURE AND AORTIC STENOSIS ETC.) AND DID NOT ATTRIBUTE TO THE INCIDENT.

  Patient problems: Perforation of Vessels; Pericardial Effusion

  MAUDE report 22290365 ↗
• InjuryMar 25, 2025Adverse 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 HEAVILY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). ALTHOUGH THE IVL PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO IVL MALFUNCTION, A POST-PROCEDURE ANGIOGRAM REVEALED A PERFORATION IN THE ARTERY. A PAPYRUS STENT WAS PLACED, AND UPON REMOVAL OF THE STENT DELIVERY SYSTEM, THE DELIVERY SYSTEM CAUGHT ON THE STENT CAUSING IT TO COLLAPSE, PREVENTING THE PLACEMENT OF AN ONYX DRUG-ELUTING STENT (DES) AS INITIALLY PLANNED. THE PATIENT'S CONDITION DETERIORATED AND WAS SENT TO SURGERY. AS OF THE DATE OF THIS REPORT, THE PATIENT IS RECOVERING WELL AND HAS HAD THE IMPELLA REMOVED. THE PHYSICIAN BELIEVES THAT THE PERFORATION WAS CAUSED BY SHOCKWAVE. HOWEVER, HE CLARIFIES THAT THE COMPLICATIONS AFTER AND LEADING TO THE PATIENT'S SURGERY WERE UNRELATED TO THE SHOCKWAVE IVL CATHETER. HE STATES THAT THE NEED FOR SURGERY WAS DUE TO THE DRUG-ELUTING STENT BECOMING STUCK ON THE PAPYRUS STENT.

  Patient problems: Perforation of Vessels

  MAUDE report 21691490 ↗
• 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. 120 PULSES WERE SUCCESSFULLY DELIVERED AT 4 ATM. A DRUG ELUTING STENT (DES) WAS PLACED IN THE LAD FOLLOWED BY POST-DILATATION WITH A NON-SHOCKWAVE BALLOON CATHETER. THERE WAS NO PATIENT SEQUALAE REPORTED. ADDITIONALLY, THERE WAS NO IVL MALFUNCTION REPORTED. THE PATIENT WAS DISCHARGED THE DAY OF THE INDEX PROCEDURE. THIS EVENT WAS SENT TO THE CLINICAL EVENTS COMMITTEE (CEC) FOR ADJUDICATION OF THE MYOCARDIAL INFARCTION (MI). THE CEC DETERMINED THAT THE MI WAS A NON Q-WAVE MI ATTRIBUTABLE TO THE TARGET VESSEL. THE MI WAS REPORTED TO OCCUR THE SAME DAY AS THE INDEX PROCEDURE. ADDITIONALLY, THE CEC NOTED A LOSS OF SIDE BRANCH. THEY DETERMINED THAT THE MI WAS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE.

  Patient problems: Myocardial Infarction

  MAUDE report 21415629 ↗
• InjuryFeb 7, 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 RIGHT CORONARY ARTERY (RCA). 10 PULSES WERE SUCCESSFULLY DELIVERED AT A MAX OF 6 ATM. THERE WAS NO IVL MALFUNCTION REPORTED. PRIOR TO THE PROCEDURE, THE PATIENT'S CREATINE KINASE-MB (CK-MB) WAS MEASURED AT NORMAL BASELINE LEVEL. WITHIN FORTY-EIGHT (48) HOURS AFTER THE PROCEDURE, THE PATIENT'S CM-MB LEVELS BECAME ELEVATED TO 100 TIMES THE UPPER NORMAL LIMIT (ULN). THE PATIENT WAS DISCHARGED. THIS EVENT WAS ADJUDICATED BY THE CLINICAL EVENTS COMMITTEE (CEC) WHICH CONFIRMED A NON Q-WAVE MYOCARDIAL INFARCTION WAS ATTRIBUTABLE TO THE TARGET VESSEL. THE CEC NOTED LOSS OF SIDE BRANCHES IN THE RCA AS WELL AS ST ELEVATION IN INFERIOR LEADS POST-INDEX PROCEDURE. 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 21330059 ↗
• MalfunctionJan 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE CORONARY ARTERY. IT WAS NOTED THAT 10 PULSES WERE DELIVERED AT AN UNKNOWN PRESSURE. IT WAS REPORTED THAT DURING THE PROCEDURE, THERE WAS A COMPLETE SEPARATION OF THE IVL CATHETER, WHICH REMAINED INSIDE THE PATIENT WHEN IT DETACHED. IT IS UNKNOWN WHETHER THE DEVICE WAS SUCCESSFULLY PREPPED OR IF THE BALLOON WAS FULLY DEFLATED BEFORE ATTEMPTING REMOVAL FROM THE SHEATH. ALTHOUGH THE PROCEDURE WAS COMPLETED, THE IVL PROCEDURE WAS NOT SUCCESSFUL. THE PATIENT REMAINED HOSPITALIZED BEFORE THE PATIENT WAS BROUGHT BACK TO THE LAB TWO DAYS LATER FOR A SECOND PROCEDURE TO RETRIEVE THE REMAINING CATHETER. APPROXIMATELY 28 CM OF THE DISTAL CATHETER WAS SNARED AND REMOVED FROM THE ASCENDING AORTA. THE LOCATION OF THE DETACHMENT RELATIVE TO THE BLUE STRAIN RELIEF IS UNKNOWN. ONCE THE CATHETER WAS REMOVED, NO FURTHER INTERVENTION WAS NECESSARY. IT IS ALSO UNCLEAR WHETHER BALLOON ANGIOPLASTY WAS PERFORMED. THE PHYSICIAN COULD NOT PROVIDE A REASONABLE EXPLANATION FOR THE BALLOON DETACHING FROM THE CATHETER. THE PATIENT HAS SINCE RECOVERED FROM THE PROCEDURE, WITH NO ADDITIONAL ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21236086 ↗
• MalfunctionJan 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A SHOCKWAVE C2+ CORONARY (4.0MM X 12MM) INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) USING A 6F GUIDE LINER. UPON REMOVAL, THE IVL BALLOON CAUGHT ON THE GUIDE LINER AND DETACHED FROM THE CATHETER WHILE INSIDE THE PATIENT. IT WAS NOTED THAT THE DETACHED IVL CATHETER COMPONENT REMAINED ATTACHED TO THE GUIDE LINER, ALLOWING FOR COMPLETE REMOVAL FROM THE BODY. WHILE THE PHYSICIAN REPORTED THAT THE BALLOON WAS FULLY DEFLATED, AND NO EXCESSIVE FORCE WAS USED DURING REMOVAL, STAFF INDICATED OTHERWISE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER GAINING ALTERNATE ACCESS. THE PHYSICIAN NOTED THAT THE BALLOON WAS DEFLATED AND DID NOT MEET RESISTANCE UNTIL CONTACTING THE GUIDE LINER. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED BY REMOVING THE RADIAL SHEATH AND GAINING ALTERNATIVE ACCESS. NO PATIENT DEMOGRAPHIC INFORMATION OR CONCOMITANT DEVICE USAGE WAS MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21073462 ↗
• InjuryOct 8, 2024Adverse 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. ON (B)(6) 2024, A SHOCKWAVE C2+ INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. NSTEMI ELEVATION WAS NOTED ATTRIBUTABLE TO TARGET VESSEL. THE IVL CATHETER DELIVERED 120 PULSES AT 4 ATMOSPHERIC PRESSURES (ATM). A STENT WAS SUCCESSFULLY DELIVERED. THERE WAS NO REPORT OF AN IVL DEVICE MALFUNCTION. MYOCARDIAL INFARCTION (MI) OCCURRED THE SAME DAY AS THE INDEX PROCEDURE, AFTER THE PROCEDURE AND PRIOR TO DISCHARGE. THE PATIENT EXPERIENCED SHARP CHEST PAIN RADIATING TO THE RIGHT SHOULDER AND ELEVATED TROPONIN LEVELS (467 TIMES THE NORMAL LIMIT) FOLLOWING THE LOSS OF A SEPTAL BRANCH. THE PATIENT WAS GIVEN ASPIRIN WITH GOOD EFFECT. AN EKG (ELECTROCARDIOGRAM) WAS PERFORMED, SHOWING NO ST CHANGES OR ABNORMALITIES. THE PATIENT WAS DISCHARGED 5 DAYS LATER. THE CLINICAL SITE HAS DETERMINED THAT THE RELATIONSHIP OF THE MI AND SUBSEQUENT CHEST PAIN TO BOTH THE STUDY AND PROCEDURE WAS PROBABLE/DEFINITE.

  Patient problems: Chest Pain; Myocardial Infarction

  MAUDE report 20403558 ↗
• DeathOct 2, 2024Off-Label Use; Off-Label Use

  TWO (2) SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETERS WERE USED TO TREAT A LESION IN THE CORONARY ARTERIES. THE FIRST CATHETER (C2PIVL4012) WAS PREPPED USING 100% CONTRAST WHICH IS CONSIDERED OFF-LABEL (INSTRUCTIONS FOR USE INDICATE 50/50 CONTRAST/SALINE MEDIUM). THE PHYSICIAN DELIVERED 2 PULSES BEFORE AN ERROR 81 (CATHETER ISSUE INDICATING RESISTOR VALUES FROM CATHETER DO NOT MATCH CATHETER DATA TABLE) WAS OBSERVED. A SECOND CATHETER (C2PIVL3512) WAS PREPPED ALSO USING 100% CONTRAST AND ERROR 81 WAS OBSERVED AGAIN. GENERATOR TROUBLESHOOTING DID NOT RESOLVE THE ERROR. DESPITE THE CATHETER ERRORS, THE PHYSICIAN WAS ABLE TO RESTORE BLOOD FLOW AND PLACE 2 STENTS. HOWEVER, THE PATIENT DECOMPENSATED WITH A HEART ATTACK AS THEY WERE PULLED OFF THE TABLE. FOLLOWING THE USE OF AN IMPELLA HEART PUMP, THE PATIENT WENT INTO SHOCK AND EXPIRED. IT WAS REPORTED THAT THE PHYSICIAN DOES NOT BELIEVE THAT THE SHOCKWAVE IVL CATHETER LEAD TO THE PATIENT'S DEATH.

  Patient problems: Cardiac Arrest; Reduced Blood Flow; Shock

  MAUDE report 20356086 ↗
• InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY CATHETERS WERE SUCCESSFULLY USED TO TREAT LESIONS IN THE CORONARY ARTERIES. THIS REPORT IS FOR THE FIRST CATHETER REPORTED (REFER TO MDR 3015053858-2024-00052 FOR THE SECOND CATHETER). THE FIRST C2+ CATHETER WAS USED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) AND SUCCESSFULLY DELIVERED 60 PULSES. THE SECOND C2+ CATHETER WAS USED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND SUCCESSFULLY DELIVERED 20 PULSES. THERE WERE NO DEVICE MALFUNCTIONS REPORTED FOR EITHER CATHETER. AFTER THE PROCEDURE WAS PERFORMED ON (B)(6) 2024, THE PATIENT WAS FOUND TO HAVE TYPE A AORTIC DISSECTION AFTER COMPLAINTS OF CHEST PAIN. THE PATIENT WAS THEN TREATED WITH IV ESMOLOL AND TIGHT BLOOD PRESSURE CONTROL. THE PATIENT WAS ADMITTED TO CONTINUE OBSERVATION. 0N (B)(6) 2024, A FEW WEEKS AFTER THE INITIAL PROCEDURE WAS PERFORMED, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) WITH CHEST PAIN. THE PATIENT CONVERTED INTO ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE (RVR). THE PATIENT WAS THEN PLACED ON DITIAZEM AND CONVERTED BACK TO NORMAL SINUS RHYTHM. ADDITIONALLY, ON THAT SAME DAY, A COMPUTED TOMOGRAPHY ANGIOGRAP

  Patient problems: Atrial Fibrillation; Hematoma; Pericardial Effusion; Vascular Dissection

  MAUDE report 19397697 ↗
• InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY CATHETERS WERE SUCCESSFULLY USED TO TREAT LESIONS IN THE CORONARY ARTERIES. THIS REPORT IS FOR THE SECOND CATHETER REPORTED (REFER TO MDR 3015053858-2024-00051 FOR THE FIRST CATHETER). THE FIRST C2+ CATHETER WAS USED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) AND SUCCESSFULLY DELIVERED 60 PULSES. THE SECOND C2+ CATHETER WAS USED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND SUCCESSFULLY DELIVERED 20 PULSES. THERE WERE NO DEVICE MALFUNCTIONS REPORTED FOR EITHER CATHETER. AFTER THE PROCEDURE WAS PERFORMED ON (B)(6).2024, THE PATIENT WAS FOUND TO HAVE TYPE A AORTIC DISSECTION AFTER COMPLAINTS OF CHEST PAIN. THE PATIENT WAS THEN TREATED WITH IV ESMOLOL AND TIGHT BLOOD PRESSURE CONTROL. THE PATIENT WAS ADMITTED TO CONTINUE OBSERVATION. 0N (B)(6) 2024, A FEW WEEKS AFTER THE INITIAL PROCEDURE WAS PERFORMED, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) WITH CHEST PAIN. THE PATIENT CONVERTED INTO ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE (RVR). THE PATIENT WAS THEN PLACED ON DITIAZEM AND CONVERTED BACK TO NORMAL SINUS RHYTHM. ADDITIONALLY, ON THAT SAME DAY, A COMPUTED TOMOGRAPHY ANGIOGRAP

  Patient problems: Atrial Fibrillation; Hematoma; Pericardial Effusion; Vascular Dissection

  MAUDE report 19397696 ↗
• InjuryDec 12, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A SHOCKWAVE CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS ATTEMPTED TO TREAT AN RCA (RIGHT CORONARY ARTERY) LESION. THE CATHETER WOULD NOT CROSS DESPITE MULTIPLE PREDILATION'S, ORBITAL ATHERECTOMY, AND THE USE OF A GUIDELINER. THE SHAFT OF THE CATHETER BECAME KINKED FROM ALL THE ATTEMPTS TO CROSS. THE PROCEDURE WAS THEN COMPLETED WITH ORBITAL ATHERECTOMY AND NC (NON-COMPLIANT) BALLOONS. AFTER THE COMPLETION OF THE CASE, THE PATIENT CODED AND PERICARDIAL EFFUSION WAS FOUND. PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT RESUSCITATED AND WAS DISCHARGED TWO DAYS LATER WITH NO ISSUES.

  Patient problems: Cardiac Arrest; Pericardial Effusion

  MAUDE report 18312292 ↗