MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE E8 PERIPHERAL IVL CATHETER

Model Number	E8IVL060080
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A shockwave e8 peripheral intravascular lithotripsy (ivl) catheter was used to treat a lesion in the common femoral artery via contralateral femoral access.There was no resistance while advancing the catheter over the guidewire or through the sheath.However, it was reported that severe iliac tortuosity and the presence of prior iliac stents limited the ability to advance the catheter.The device was advanced across the aortic bifurcation but could not reach the target lesion in the common femoral artery.During catheter removal, the e8 shaft fractured and the balloon detached.All components were successfully retrieved, and no fragments were retained in the patient.No patient harm was reported.
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.Therefore, a physical examination cannot be performed.It was reported that severe iliac tortuosity and the presence of prior iliac stents limited the ability to advance the catheter.The cause of the balloon detachment could not be definitively determined based on 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.

• Brand Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE E8 PERIPHERAL IVL CATHETER
• Common Device Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE E8 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: 24722174
• Report Number: 3015053858-2026-00030
• Device Sequence Number: 10145160
• Product Code: PPN
• UDI-Device Identifier: 00195451000584
• UDI-Public: (01)00195451000584(17)270930(10)03A251014A
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K240225
• 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): 03/27/2026

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: E8IVL060080
• Device Catalogue Number: E8IVL060080
• Device Lot Number: 03A251014A
• 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: 03/05/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2025
• 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: SHEATH - UNKNOWN MANUFACTURER.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown