MAUDE Adverse Event Report: SHOCKWAVE MEDICAL INC. SHOCKWAVE LITHO CATH; SHOCKWAVE INTRAVASCULAR LITHOTRIPSY SYSTEM

Model Number	C2IVL2512
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Balloon ruptured when inflated during heart catheterization causing injury to patient's coronary artery.

• Brand Name: SHOCKWAVE LITHO CATH
• Common Device Name: SHOCKWAVE INTRAVASCULAR LITHOTRIPSY SYSTEM
• Manufacturer (Section D): SHOCKWAVE MEDICAL INC.; santa clara CA 95054
• MDR Report Key: 16618502
• Report Number: MW5115984
• Device Sequence Number: 6148987
• Product Code: QMG
• UDI-Device Identifier: 00195451000089
• UDI-Public: (01)00195451000089(17)240831(10)A220817C
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/22/2023

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 Expiration Date: 08/31/2024
• Device Model Number: C2IVL2512
• Device Lot Number: A220817C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White