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	Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
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.The inability to deflate the balloon would make it difficult to remove from the treatment site.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.
Event or Problem Description
A shockwave c2 aero coronary intravascular lithotripsy (ivl) catheter was used to treat a lesion in the coronary arteries.A total of 120 ivl pulses were successfully delivered.It was reported that the ivl balloon was having great difficulty deflating after treatment which was observed at the treatment site prior to attempting to withdraw the ivl catheter from the guide catheter.On removal of the ivl catheter from the patient, the balloon was intact but noted to be partially inflated.After discussion with the physician, the balloon was confirmed to be holding pressure and there were no functional issues with the device or with ivl therapy delivery.The catheter was delivered over a sion blue wire using a 7 fr guide.No patient harm was reported.
Additional Manufacturer Narrative
Section h6, annex d (investigation conclusions) was updated to remove "cause traced to component failure" (code # 4307) which was included in the initial report.The code "manufacturing deficiency" (code #23) will remain unchanged from the initial report.

• 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: 23711433
• Report Number: 3015053858-2025-00148
• Device Sequence Number: 21501139
• Product Code: QMG
• UDI-Device Identifier: 00195451000607
• UDI-Public: (01)00195451000607(17)270731(10)13A250715A
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: 13A250715A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/16/2025
• 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: 7FR GUIDE CATHETER - UNKNOWN MANUFACTURER; SION BLUE WIRE - ASAHI
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown