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

Model Number	C2AIVL2512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	08/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A shockwave c2 aero coronary intravascular lithotripsy (ivl) catheter was used to treat an unspecified lesion.It was reported that during ivl treatment, a vessel rupture/perforation was reported following the delivery of approximately 30 pulses at 4 atmospheres (atm).It was reported that the procedure was interrupted and the planned treatment could not be fully completed.The patient was admitted for observation and was reported to be doing well.No additional patient outcome information was provided.Multiple attempts have been made to obtain additional information regarding the event, including procedural details, patient outcome, and any interventions performed; however, no further information has been provided to date.There was no ivl malfunction reported.
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.Therefore, a physical examination cannot be performed.Shockwave attempted to gather additional information however; no additional information was made available.The cause of the vessel rupture/perforation and subsequent hospitalization could not be definitively determined based on the information available.There was no ivl malfunction reported.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 Aero Coronary IVL Catheter
• Common Device Name: Shockwave IVL System with the Shockwave C2 Aero 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; satna clara, CA 95054
• MDR Report Key: 50487899
• Report Number: 3015053858-2026-00101
• Device Sequence Number: 13343134
• Product Code: QMG
• UDI-Device Identifier: 00195451000591
• UDI-Public: (01)00195451000591(17)280229(10)24A260318B
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P200039/S015
• 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,Followup
• Report Date (Section B): 09/01/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: C2AIVL2512
• Device Catalogue Number: C2AIVL2512
• Device Lot Number: 24A260318B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 08/27/2026
• Supplement Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2026
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening; Other
• Patient Sex: Unknown