MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE S4 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER; INTRAVASCULAR LITHOTRIPSY (IV) CATHETER

Model Number	S4IVL3040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Cardiogenic Shock (2262); Pseudoaneurysm (2605)
Date of Event	11/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.For investigation therefore, a physical examination could not be performed.The cause of the event could not be definitively determined with the limited information available.Based on the reported event, following ivl treatment during the initial procedure on (b)(6) 2022, the patient presented to the emergency room (er) on (b)(6) 2022 with left knee pain where it was x-rayed and the patient subsequently discharged home.A couple of days later, the patient returned to the er and underwent a computed tomography angiography (cta) to the chest, abdomen, and pelvis.It was found that there was extravasation of the left external iliac artery (eia) pseudoaneurysm.The site has reported a probable relationship to the device.Shockwave medical, inc.Has controls in place to ensure devices are built to approved procedures and meet lot release acceptance criteria prior to being distributed.
Event or Problem Description
Post btk ii study using a shockwave peripheral lithotripsy catheter, the patient presented to the emergency department (ed) due to several days of left knee pain.The staff took x-rays and was discharged to home.The patient returned to the ed and underwent a computed tomography angiography (cta) to the chest, abdomen, and pelvis.It was found that there was extravasation of the left external iliac artery (eia) pseudoaneurysm.The patient was provided 2.25 liters of intravenous fluids and 3 units of packed red blood cells (prbc) due to blood loss.The patient also started on levophed (norepinephrine bitartrate).As of this date (b)(6) 2022, the patient is still in the hospital.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the additional information which was inadvertently left out during the submission of the initial report.
Event or Problem Description
Additional information was inadvertently left out in the initial report.It was also reported that the patient experienced cardiogenic shock related to acute blood loss/ anemia.

• Brand Name: SHOCKWAVE S4 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: INTRAVASCULAR LITHOTRIPSY (IV) CATHETER
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95054
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara, CA 95054
• MDR Report Key: 15911914
• Report Number: 3015053858-2022-00066
• Device Sequence Number: 20182934
• Product Code: PPN
• UDI-Device Identifier: 00195451000058
• UDI-Public: (01)00195451000058(17)230430(10)A210430D
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K198140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: S4IVL3040
• Device Catalogue Number: S4IVL3040
• Device Lot Number: A210430D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• 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: COMPUTED TOMOGRAPHY DEVICE (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male