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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Catheter was undeployable once inserted into the coronary artery.

• 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: 13577625
• Report Number: 13577625
• Device Sequence Number: 14545016
• Product Code: QMG
• UDI-Device Identifier: 00195451000089
• UDI-Public: (01)00195451000089
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 02/07/2022
• Report Date (Section F): 02/07/2022

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
• Device Lot Number: A2109201
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2022
• 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
• Patient Sex: Male
• Patient Weight: 117 KG
• Date Report Sent to FDA: 02/07/2022