MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE L6 PERIPHERAL IVL CATHETER

Model Number	L6IVL080030
Medical Device Problem Codes	Off-Label Use (1494); 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	03/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A shockwave l6 peripheral intravascular lithotripsy (ivl) catheter was used to treat a lesion in the iliac artery.It was reported that the ivl balloon sheared off the catheter upon reinsertion of the device, which is off-label per the device instructions for use.The distal ivl balloon segment was noted to be adjacent to an internal iliac stent and the ivl balloon detached inside the patient.The detached balloon fragment was retrieved by advancing a 7fr sheath, followed by a 5fr slender, over the balloon fragment while working over a 0.018" wire.The sheath was advanced further to capture the material, and significant force was required to pass the sheath over and extract the fragment.No additional containment or intervention was needed following successful removal of the ivl device components.There was no additional information available, and no additional patient sequelae reported.The procedure was completed without issues, and 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.The root cause of the difficulty to advance and subsequent detachment of the ivl catheter could not be definitively determined based on the information available.It was reported that the ivl catheter was reinserted into the patient which is off-label per the device instructions for use.This device is intended for single (one) time use only and is not to be re-sterilized and/or reused.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 L6 PERIPHERAL IVL CATHETER
• Common Device Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE L6 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: 24701688
• Report Number: 3015053858-2026-00028
• Device Sequence Number: 15964136
• Product Code: PPN
• UDI-Device Identifier: 00195451000386
• UDI-Public: (01)00195451000386(17)270831(10)04A250903A
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K240954
• 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): 03/26/2026

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: L6IVL080030
• Device Catalogue Number: L6IVL080030
• Device Lot Number: 04A250903A
• 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: 03/03/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2025
• 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: 0.018" WIRE - UNKNOWN MANUFACTURER.; 5FR SLENDER - UNKNOWN MANUFACTURER.; 7FR SHEATH - UNKNOWN MANUFACTURER.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown