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

Model Number	3.5 X 12MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During an interventional procedure in cardiac catheter lab, shockwave lithotripsy device was prepped outside of patient's body successfully and then device advanced into patient's artery.The prepping syringe was removed and the stopcock was attached to the inflation device.When the inflation device pulled negative on device, air kept being pulled out of shockwave (balloon).The stopcock and the inflation device were then replaced with new stopcock and new inflation device and air was still coming out.Doctor did not want to use this device.Device removed and no harm done to patient.A new shockwave device was used successfully.

• 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: 15949587
• Report Number: 15949587
• Device Sequence Number: 20666319
• Product Code: QMG
• UDI-Device Identifier: 00195451000102
• UDI-Public: (01)00195451000102(17)240430
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/06/2022
• Report Date (Section F): 12/06/2022

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: 3.5 X 12MM
• Device Catalogue Number: C2IVL3512
• Device Lot Number: A2204194
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2022
• 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: 67 KG
• Patient Race: White
• Date Report Sent to FDA: 12/06/2022