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

Model Number	S4IVL2540
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Restenosis (4576); Reduced Blood Flow (4598)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.Therefore, a physical examination cannot be performed.The cause of the monophasic flow and re-occlusion could not be definitively determined based on the information available.Balloon ruptures are a known failure mode with a low probability of occurrence.Contributing factors include patient calcium, damage caused when the balloon wall comes into close contact with the device emitters, likely causes include (a) an irregular calcium lesion capable of compressing the balloon wall into close proximity with the emitter(s) and/or (b) an incompletely inflated balloon.The shockwave intravascular lithotripsy (ivl) system with the shockwave s4 peripheral ivl catheter generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of an artery stenosis using low balloon pressure not to exceed 4 atm during ivl treatment, and 6 atm for post dilatation.The associated patient risk for this failure mode is low and adequately captured in swmi's risk documentation 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
This event was reported to shockwave via the post market btk ii study.On (b)(6) 2022, a shockwave s4 peripheral intravascular lithotripsy (ivl) catheter was used to treat a lesion in the mid posterior tibial vessel.A total of 154 ivl pulses were delivered at 4 atmospheres of pressure (atm) before the balloon ruptured.However, it was reported that the subject had no complications from the balloon rupture.Subsequently, the procedure was completed with post dilation performed using a percutaneous transluminal angioplasty (pta) balloon.The patient was discharged the same day as the index procedure.Approximately 4 months after the index procedure, it was reported that the patient had a cerebrovascular accident (cva), or stroke.It was resolved 2 days after, but the treatment provided is unknown.The clinical site determined that the cva was not related to the study device or procedure.In a 6-month follow-up, an ultrasound showed monophasic flow and possible re-occlusion.The clinical site determined no further actions were required.No additional information was provided, and the patient outcome is unknown.The clinical site determined that the posterior tibial re-occlusion was possibly related to the study device and not related to the procedure.Alongside the re-occlusion, pitting edema was also reported in the 6-month follow-up.The clinical site determined that the pitting edema was not related to the study device and procedure.Approximately 10 months after the index procedure, the patient presented to the emergency department with hemorrhoids.The patient was not admitted, but a follow-up with a gastrointestinal (gi) specialist was scheduled.The clinical site determined that the hemorrhoids were not related to the study device and procedure.No additional information was provided.

• 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: 24384339
• Report Number: 3015053858-2026-00016
• Device Sequence Number: 21392412
• Product Code: PPN
• UDI-Device Identifier: 00195451000041
• UDI-Public: (01)00195451000041(17)231031(10)A211015A
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: S4IVL2540
• Device Catalogue Number: S4IVL2540
• Device Lot Number: A211015A
• 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: 01/27/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2021
• 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: POST-DILATATION PTA BALLOON - 2.5 X 120 - ABBOTT
• Outcome Attributed to Adverse Event: Other
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White