MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

Model Number	C2IVL2512
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.Therefore, a physical examination cannot be performed.The cause of the difficulty to advance and subsequent dissection could not be definitively determined based on the information available.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.Complaint trends will continue to be monitored.
Event or Problem Description
A shockwave c2 coronary intravascular lithotripsy (ivl) catheter was used to treat a left anterior descending artery (lad).It was reported that the catheter was unable to reach the lesion in the lad.Pre-dilation was performed using pre-extension and post-extension techniques, and access was gained via the radial artery and no resistance was encountered while tracking the catheter over the guidewire.Angiography revealed a severe dissection at the opening of the lad following ivl catheter retraction.The procedure was aborted and successfully completed using an alternative method, with no kinks or balloon damage observed during the process.The patient, with no pre-existing conditions, was treated for a grade c dissection, which was managed by transfer to surgery with a coronary artery bypass graft with no further complications.
Additional Manufacturer Narrative
The device referenced in this report was returned to shockwave medical, inc.Investigation results indicate that all emitters showed little to no signs of wear, with no physical damage observed on the balloon surface or the distal tip.A shipping mandrel inserted from the distal tip passed through the sheath with minimum resistance and was removed successfully.Additionally, the device was passed through the 6f introducer sheath, inserted and advanced with minimum resistance, and exited through the sheath.Based on testing results of the returned device and review of the images provided, the reported issue could not be duplicated.As a result, the root cause of the difficulty to advance could not be definitively determined.

• Brand Name: SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (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: 22909476
• Report Number: 3015053858-2025-00103
• Device Sequence Number: 18375807
• Product Code: QMG
• UDI-Device Identifier: 00195451000089
• UDI-Public: (01)00195451000089(17)260930(10)02A240916A
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P200039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: C2IVL2512
• Device Catalogue Number: C2IVL2512
• Device Lot Number: 02A240916A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• 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: HIGH PRESSURE BALLOON MANUFACTURER UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 65 YR
• Patient Sex: Female