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

Model Number	C2AIVL3012
Medical Device Problem Codes	Crack (1135); Inflation Problem (1310); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A shockwave coronary c2 aero intravascular lithotripsy (ivl) catheter was used to treat a lesion in the coronary arteries.There were no problems removing the device from its packaging or removing the balloon protective sheath.There was significant air present in the endoflator tubing.A new stopcock and endoflator were then used, and a total of 20 ivl pulses were delivered.However, the distal balloon did not fully inflate.A small crack in the catheter hub was reported by the operator, and the balloon could not deflate or be retrieved.Thus, the catheter shaft was cut, and the balloon was able to deflate and be successfully retrieved from the patient.A new 3.0mm shockwave c2 aero was used without issues, delivering all pulses , and there were no patient sequelae reported.
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The reported failures of catheter hub damage, unable to inflate, and unable to deflate could not be confirmed.Per the investigation, the balloon was able to successfully inflate and deflate within the c2 aero product specification.There was no damage to the shaft or the hub that was noted during the procedure.The hub section of the catheter was inflated and no leaks from the hub were noted.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: 24205868
• Report Number: 3015053858-2026-00008
• Device Sequence Number: 9635605
• Product Code: QMG
• UDI-Device Identifier: 00195451000607
• UDI-Public: (01)00195451000607(17)270831(10)10A250925A
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/28/2026

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: 10A250925A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2025
• 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: Required Intervention; Other
• Patient Sex: Unknown