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

Model Number	C2AIVL3012
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
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 reported balloon catheter deflation failure could not be definitively determined based on the information available.The device successfully delivered 10 pulses prior to the reported event; therefore, this is not considered an out-of-the-box failure.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 aero coronary intravascular lithotripsy (ivl) catheter was used to treat a lesion in the coronary artery.It was reported that after the catheter delivered 10 pulses, the physician attempted to deflate the balloon; however, the balloon would not deflate.Multiple attempts were made to deflate the balloon by attaching a syringe and aspirating, but these attempts were unsuccessful.The physician then intentionally overinflated the balloon several times to cause it to rupture, and the catheter was subsequently removed from the patient.A second shockwave c2 aero coronary intravascular lithotripsy (ivl) catheter was opened and used; however, an error 81 code was observed and could not be cleared.The procedure was subsequently completed successfully.The patient was reported to be recovering and was discharged per routine.This report is for the first catheter.

• 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; santa clara, CA 95054
• MDR Report Key: 50871768
• Report Number: 3015053858-2026-00122
• Device Sequence Number: 10690654
• Product Code: QMG
• UDI-Device Identifier: 00195451000607
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: C2AIVL3012
• Device Catalogue Number: C2AIVL3012
• Device Lot Number: 01A260516B
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2026
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Race: White