MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE S4 PERIPHERAL IVL CATHETER

Model Number	S4IVLK4040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	05/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.Based on the reported information, there was no ivl device malfunction.During the investigation, no issues were seen with the returned catheter.The cause of the pain and swelling/edema could not be definitively determined with the information available.Shockwave medical has controls in place to ensure devices are built to approved procedures and meet lot release acceptance criteria prior to being distributed.A review of the manufacturing and test documentation for subject lot does not reveal any issues with the manufacturing of the device.The device passed all of shockwave medical, inc.Acceptance criteria prior to shipping.
Event or Problem Description
A shockwave s4 peripheral intravascular lithotripsy (ivl) catheter was used to treat a lesion in the popliteal artery.A total of 20 ivl pulses were delivered, during which the patient experienced leg pain.The physician proceeded to deliver a subsequent cycle of ivl pulses, but the patient declined continuation of ivl treatment due to pain.The procedure was completed using atherectomy followed by drug-coated balloon (dcb) angioplasty, with no reported patient harm.There was no ivl device malfunction reported.During treatment, the patient reported deep, aching pain with a severity of 7-8 on a 10-point scale.Additionally, the patient reported mild calf pain and bilateral leg swelling.

• Brand Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE S4 PERIPHERAL IVL CATHETER
• Common Device Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE S4 PERIPHERAL IVL CATHETER
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95054
• Manufacturer (Section G): 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: 25459730
• Report Number: 3015053858-2026-00058
• Device Sequence Number: 8670134
• Product Code: PPN
• UDI-Device Identifier: 00195451000348
• UDI-Public: (01)00195451000348(17)260630(10)11B240626A
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

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: 06/30/2026
• Device Model Number: S4IVLK4040
• Device Catalogue Number: S4IVLK4040
• Device Lot Number: 11B240626A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Female