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	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shockwave c2 aero coronary intravascular lithotripsy (ivl) catheter was used during a procedure to treat a lesion in the coronary artery.The device was prepped successfully.After 20 ivl pulses were delivered, the physician was unable to deflate the balloon.The physician cut the back of the balloon to allow contrast to drain and the balloon to partially deflate.The balloon was then removed by advancing a guide-extension catheter over it, which did not involve puncturing the balloon.The balloon remained unable to deflate for only a couple of minutes.The patient remained hemodynamically stable throughout and is currently doing well.The patient did not require additional hospitalization, and the procedure was completed.There was no report of any patient harm that occurred.
Additional Manufacturer Narrative
The device referenced in this report has been returned to shockwave medical, inc.An evaluation of the reported issue including review of intraoperative images is being investigated.After the investigation is completed, a supplemental report will be submitted.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.
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The reported failure of not being able to completely deflate the balloon could not be confirmed.The balloon was able to be completely deflated; however, it was noted that the deflation was slower than normal.Based on the investigation observations, the slow deflation can be attributed to a combination of excessive adhesive and the proximal end of the polyolefin being flared.The following sections have been also been updated following investigation completion of the device on 08jan2026: 1.H6, type of investigation (b): updated from 4118 to 10.2.H6, investigation findings (c): updated from 3233 to 114.3.H6, investigation conclusions (d): updated from 11 to 23.

• 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: 23888683
• Report Number: 3015053858-2025-00158
• Device Sequence Number: 4669018
• Product Code: QMG
• UDI-Device Identifier: 00195451000607
• UDI-Public: (01)00195451000607(17)270831(10)01A250919A
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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: 01A250919A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2025
• 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-EXTENSION CATHETER, UNKNOWN MANUFACTURER.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown