MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

Model Number	L6IVL080030
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
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 arteries.300 ivl pulses were delivered at 3 atm.The procedure was successful, and the catheter completely separated upon removal from the 7fr sheath.There was no kinking observed on the device during the procedure.The balloon was fully deflated and all components were successfully retrieved without the need for additional devices.There were no fragments left inside the patient.A covered stent was placed as originally planned, and balloon angioplasty was performed after the stent was deployed.There was no patient harm.
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The reported failure, detachment of device or device component, was confirmed.The returned catheter was found to be damaged and detached at the inner member and outer shaft.The outer shaft, balloon and distal tip were not returned and could not be investigated further.Based on the reported information and investigation observations, the device likely got stuck during removal and the force used to remove the device caused the outer shaft and balloon to detach.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 L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (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: 21753423
• Report Number: 3015053838-2025-00054
• Device Sequence Number: 10161698
• Product Code: PPN
• UDI-Device Identifier: 00195451000386
• UDI-Public: (01)00195451000386(17)260731(10)12A240701A
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2025

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 Expiration Date: 07/31/2026
• Device Model Number: L6IVL080030
• Device Catalogue Number: L6IVL080030
• Device Lot Number: 12A240701A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 7FR SHEATH - UNKNOWN MANUFACTURER; V18 WIRE - BOSTON SCIENTIFIC
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown