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	Difficult to Remove (1528)
Health Effect - Clinical Code	Non specific EKG/ECG Changes (1817)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A shockwave c2 aero coronary intravascular lithotripsy (ivl) catheter was used to treat a proximal left anterior descending (lad) lesion.A total of 70 ivl pulses were successfully delivered at 4 atmospheres (atm).The balloon was prepared with a 50/50 contrast/saline mixture and performed triple negative vacuum using a 3-way stopcock and a 20 cc syringe.It was reported that during ivl treatment, after the 7th cycle the balloon took unusually longer to deflate.Therefore, the physician elected to suspend cycle delivery.The ivl balloon would not fully deflate after the first one to two cycles so the indeflator was changed and a syringe was used to aspirate the balloon with the stopcock to facilitate deflation.During attempts to deflate the balloon, the patient developed transient st-segment elevations.The balloon was fully deflated and the ivl catheter was removed over the wire and out of the sheath without further difficulty.The st elevations were resolved immediately following successful deflation of the balloon and the patient returned to baseline.The lesion was subsequently stented and post dilated.The procedure was completed successfully, and no patient harm was reported.
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The reported failure of difficulties to completely deflate the balloon was not confirmed.The returned device was found separated into two pieces with a break located at the distal end of the strain relief.During the investigation, the balloon was found to deflate and inflate per testing procedure.The cause of the failure to deflate and subsequent difficulty to remove could not be determined.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 95054
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara, CA 95054
• MDR Report Key: 23967990
• Report Number: 3015053858-2026-00002
• Device Sequence Number: 20020240
• Product Code: QMG
• UDI-Device Identifier: 00195451000607
• UDI-Public: (01)00195451000607(17)270831(10)06A250807A
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: 200039/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): 01/05/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: C2AIVL3012
• Device Catalogue Number: C2AIVL3012
• Device Lot Number: 06A250807A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2025
• 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: 20 CC SYRINGE - MANUFACTURER UNKNOWN; 3 WAY STOPCOCK - MANUFACTURER UNKNOWN; STENT - MANUFACTURER UNKNOWN
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown