MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER; SHOCKWAVE INTRAVASCULAR LITHOTRIPSY SYSTEM

Model Number	2.5 X 12MM
Health Effect - Clinical Code	Aortic dissection (4870)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Cardiac catheterization complicated by lithotripsy balloon rupture resulting in dissection back into left main and left circumflex requiring stenting of the left main into the lad [left anterior descending] and culotte stenting of the proximal left circumflex finished with kissing balloons.

• Brand Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER
• Common Device Name: SHOCKWAVE INTRAVASCULAR LITHOTRIPSY SYSTEM
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95054
• MDR Report Key: 22122580
• Report Number: 22122580
• Device Sequence Number: 4251299
• Product Code: QMG
• UDI-Device Identifier: 00195451000089
• UDI-Public: (01)00195451000089
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/14/2025
• Report Date (Section F): 05/14/2025

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: 2.5 X 12MM
• Device Catalogue Number: C2IVL2512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 05/14/2025