MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

Model Number	C2PIVL3012
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Arrhythmia (1721); Cardiac Arrest (1762); Ventricular Fibrillation (2130)
Date of Event	02/18/2025
Type of Reportable Event	Death
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 ventricular fibrillation, cardiac arrest, and subsequent patient death could not be definitively determined based on the information available.The patient was reported to have a long history of cardiac issues.The physician noted the possibility of air injection post-rupture but did not directly attribute the issues to the ivl device.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.
Event or Problem Description
A shockwave c2+ coronary intravascular lithotripsy (ivl) catheter was used to treat a heavily calcified lesion in the left circumflex artery (lcx).The procedure faced initial accessibility challenges, requiring small balloons and significant ballooning with a non-compliant (nc) balloon.Intravascular ultrasound (ivus) was difficult but eventually successful before ivl.During the procedure, 50 ivl pulses were delivered at 4 atm before the balloon ruptured.It was reported that the tech may have injected air following the rupture.The patient went into ventricular fibrillation (v fib) multiple times, was immediately shocked, a code was called, and the patient was intubated.Emergency medications were administered.The patient had a return of spontaneous circulation (rosc) but continued to go back into v fib over the next 45 minutes.The patient passed away following the code, approximately 45 minutes later.The last image showed the vessel was open, but imaging stopped when v fib occurred, and the code began.The physician noted the possibility of air injection post-rupture but did not directly attribute the issues to the ivl device.

• Brand Name: SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (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: 21590192
• Report Number: 3015053838-2025-00048
• Device Sequence Number: 18209372
• Product Code: QMG
• UDI-Device Identifier: 00195451000010
• UDI-Public: (01)00195451000010(17)260831(10)27A240820B
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2025

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 Expiration Date: 08/31/2026
• Device Model Number: C2PIVL3012
• Device Catalogue Number: C2PIVL3012
• Device Lot Number: 27A240820B
• 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: 02/18/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2024
• 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: 0.014 WIRES - UNKNOWN MANUFACTURER; GUIDELINER - UNKNOWN MANUFACTURER; IVUS - UNKNOWN MANUFACTURER; NC PTA BALLOON - UNKNOWN MANUFACTURER; NC PTA BALLOON - UNKNOWN MANUFACTURER
• Outcome Attributed to Adverse Event: Other; Death
• Patient Age: 60 YR
• Patient Sex: Male