MAUDE Adverse Event Report: Shockwave Medical, Inc. Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter

Model Number	C2PIVL2512
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Perforation of Vessels (2135); Pericardial Effusion (3271)
Date of Event	08/04/2026
Type of Reportable Event	Death
Event or Problem Description
A shockwave c2+ coronary intravascular lithotripsy (ivl) 2.5 x 12 mm catheter was used to treat a 95% stenosed mid left anterior descending (lad) lesion with a 90-degree turn at the location of the calcific lesion.The physician attempted to cross the lesion with the ivl catheter; however, the catheter would not cross.A 2.5 mm non-complaint (nc) sapphire balloon was used to pre-dilate the lesion, and the ivl catheter was subsequently reinserted.During the second cycle of ivl treatment in the lad, a perforation occurred.The ivl catheter was removed, and fluoroscopy and angiography revealed a perforation at the site of the bifurcation lesion between the lad and diag 1, where eccentric plaque was present.An urgent drug-eluting stent (des) was delivered to treat the perforation.No post-dilation was performed following ivl treatment, as the patient was unstable and initial angiography following ivl identified the perforation.A bedside echocardiogram identified a pericardial effusion, and pericardiocentesis was performed with approximately 200 ml removed from the pericardial sac.Protamine was administered, and internal tamponade was performed with a coronary balloon.Fluoroscopy subsequently indicated the perforation appeared sealed.An impella device and permanent pacemaker were also placed.Continuous echocardiographic monitoring was performed before and after pericardiocentesis.Despite intervention, the patient's condition deteriorated, requiring emergent intubation.Cardiopulmonary resuscitation (cpr) and advanced cardiovascular life support (acls ) were initiated; however, the patient never regained a pulse, and time of death was declared in the catheterization laboratory.According to the physician, this was a high-risk pci involving a 90% stenosed bifurcation lesion between the lad and diag 1, and the patient's comorbidities increased the overall procedural risk.The physician stated that plaque rupture may have occurred during use of either the nc balloon or the ivl balloon.Because both devices were used before the perforation was identified, the physician was unable to determine device causation.Final angiography reportedly demonstrated no active perforation.
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.Therefore, a physical examination cannot be performed.The cause of the perforation, pericardial effusion, cardiac arrest, and subsequent death could not be definitively determined based on the information available.Shockwave medical has controls in place to ensure devices are built to approved procedures and meet lot release acceptance criteria prior to being distributed.A review of the manufacturing and test documentation for subject lot does not reveal any issues with the manufacturing of the device.The device passed all of shockwave medical, inc.Acceptance criteria prior to shipping.

• Brand Name: Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter
• Common Device Name: Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter
• Manufacturer (Section D): Shockwave Medical, Inc.; 5403 betsy ross drive; santa clara CA 95054
• Manufacturer (Section G): Shockwave Medical, Inc.; 5403 betsy ross drive; santa clara CA 95054
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara, CA 95054
• MDR Report Key: 50227732
• Report Number: 3015053858-2026-00093
• Device Sequence Number: 10336085
• Product Code: QMG
• UDI-Device Identifier: 00195451000003
• UDI-Public: (01)00195451000003(17)271031(10)04B251126B
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P200039/S008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: C2PIVL2512
• Device Catalogue Number: C2PIVL2512
• Device Lot Number: 04B251126B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.25 Trek Compliant Balloon - Abbott.; 2.25 x 23 Xience Stent - Abbott.; 2.5 x 18 NC Sapphire balloon -Unknown manufacturer.; 2.5 x 22 NC Sapphire balloon -Unknown Manufacturer.; 2x 5fr pigtail - Unknown Manufacturer.; 2x Minamo wires - Asahi Intecc.; 5.5 Boost Guideliner - Teleflex.; 5fr Pacel Temp ppm Wire - Abbott.; 6fr glidesheath - Unknown Manufacturer.; XB3.0 Guidesheath - Cordis.
• Outcome Attributed to Adverse Event: Required Intervention; Death; Life Threatening
• Patient Age: 86 YR
• Patient Sex: Male