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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Pericardial Effusion (3271)
Date of Event	12/02/2025
Type of Reportable Event	Serious Injury
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 physician first used csi followed by optical coherence tomography (oct) which showed a dissection just distal to a nodular lesion.The physician then requested shockwave c2 aero coronary ivl catheter.After 30 ivl pulses were delivered, a coronary perforation occurred.The physician deployed two xience stents and performed 10 minutes of balloon inflation.Echocardiography was obtained, pericardiocentesis was performed, and a papyrus covered stent was placed.The physician believes the csi caused the injury.Diffuse coronary calcium was noted and the vessel appeared to split after csi and ballooning.There was no report of device malfunction.The patient remained stable and was discharged home.
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.Therefore, a physical examination cannot be performed.Based on the reported information, the cause of the perforation could not be definitively determined.There was no device malfunction.The physician believes the csi caused the injury.Diffuse coronary calcium was noted and the vessel appeared to split after csi and ballooning.A review of the event by shockwave safety determined that the reported events were possibly related to the device and causal relationship to the procedure.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 following updates were added to the following sections per additional information received 30-dec-2025: 1.B5 event narrative: updated to add that "csi" is an orbital atherectomy device.2.D10 concomitant medical products and therapy dates: added "orbital atherectomy - abbott" with a therapy date of (b)(6) 2025.3.H6 annex d investigation conclusions: additional code added, "cause traced to another device".
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 physician first used orbital atherectomy (csi) followed by optical coherence tomography (oct) which showed a dissection just distal to a nodular lesion.The physician then requested shockwave c2 aero coronary ivl catheter.After 30 ivl pulses were delivered, a coronary perforation occurred.The physician deployed two xience stents and performed 10 minutes of balloon inflation.Echocardiography was obtained, pericardiocentesis was performed, and a papyrus covered stent was placed.The physician believes the csi caused the injury.Diffuse coronary calcium was noted and the vessel appeared to split after csi and ballooning.There was no report of device malfunction.The patient remained stable and was discharged home.

• 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: 23924904
• Report Number: 3015053858-2025-00159
• Device Sequence Number: 8763675
• Product Code: QMG
• UDI-Device Identifier: 00195451000607
• UDI-Public: (01)00195451000607(17)270831(10)07A250825A
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/30/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: C2AIVL3012
• Device Catalogue Number: C2AIVL3012
• Device Lot Number: 07A250825A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2X XIENCE STENTS - ABBOTT.; COVERED STENT - PAPYRUS.; ORBITAL ATHERECTOMY - ABBOTT.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Sex: Unknown