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	Insufficient Information (4580)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 3.0mm shockwave c2 aero coronary intravascular lithotripsy (ivl) catheter was used during a procedure.The ivl balloon inflated without incident and was pulsed at 4 atm for an unknown number of pulses.Following ivl, the balloon did not deflate as expected.The balloon was removed through the guide catheter without deflating and successfully removed from the patient.The patient experienced unspecified symptoms which were resolved following the removal of the catheter.There was no reported harm to the patient.A 2nd catheter was used to successfully complete the ivl procedure.It was noted that the device was prepped per the instructions for use (ifu).
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The reported failure of "failure to deflate" was confirmed.The balloon was noted to deflate slowly.Based on the investigation, the deflation issue was due to excessive adhesive on proximal bond next to proximal marker band on the catheter.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 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 95054
• MDR Report Key: 23723380
• Report Number: 3015053858-2025-00149
• Device Sequence Number: 16125151
• Product Code: QMG
• UDI-Device Identifier: 00195451000607
• UDI-Public: (01)00195451000607(17)270731(10)03A250715A
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 12/04/2025

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: 03A250715A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER - UNKNOWN MANUFACTURER.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown