MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 AERO CORONARY IVL CATHETER

Model Number	C2AIVL3512
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A shockwave c2 aero coronary intravascular lithotripsy (ivl) catheter was used during a procedure to treat an unknown lesion.It is unknown if the device was prepped successfully, if any pulses were delivered, or if the shockwave procedure was successfully completed.It was reported that the ivl balloon failed to deflate, and it was addressed by applying repeated negative pressure.The ivl balloon did not require puncture.The length of time that the ivl balloon could not be deflated is unknown.It is unknown if there was any patient sequelae.
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The reported failure of unable to deflate was confirmed.Based on the investigation observations, not being able to deflate the balloon can be attributed to a loose component on the catheter, attributed to manufacturing.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; santa clara, CA 95054
• MDR Report Key: 24573213
• Report Number: 3015053858-2026-00024
• Device Sequence Number: 9560955
• Product Code: QMG
• UDI-Device Identifier: 00195451000614
• UDI-Public: (01)00195451000614(17)270831(10)01A250812A
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/11/2026

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: C2AIVL3512
• Device Catalogue Number: C2AIVL3512
• Device Lot Number: 01A250812A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown