MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER

Model Number	C2PIVL4012
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Remove (1528); Failure to Advance (2524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The reported failure was confirmed.The catheter was returned broken and separated into two pieces.Based on review of the returned devices, it was confirmed that all components were successfully removed from the patient.Per the reported information, the device was unable to advance through a pre-existing stent which is considered off-label use based on the instructions for use.The ivl catheter is intended to be used in de novo lesions.It is likely that the balloon got stuck upon attempts to remove through the pre-existing stent resulting in additional force and subsequent detachment of the device.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
It was reported that a shockwave c2+ coronary intravascular lithotripsy (ivl) catheter was used during a procedure to treat a patient's aorta.The ivl catheter was prepared successfully.When the ivl balloon was advanced toward the aortic bi-femoral graft, it would not advance through a pre-existing stent.The lesion was located at the proximal stent segment within the graft anastomosis.The balloon became stuck at the distal stent segment and could not be advanced to the lesion.During attempted removal, the ivl balloon and catheter broke apart from the shaft at approximately one-third of the distal length.The physician was able to snare and retrieve the entire distal catheter and balloon intact.It was reported that there was no balloon rupture or loss of pressure before the device became difficult to remove, and the balloon had been fully deflated prior to the removal attempt.There was no report of any patient harm that occurred.

• Brand Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER
• Common Device Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY 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: 23835066
• Report Number: 3015053858-2025-00155
• Device Sequence Number: 13080915
• Product Code: QMG
• UDI-Device Identifier: 00195451000034
• UDI-Public: (01)00195451000034(17)261130(10)01A241111B
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P200039/S008
• 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): 12/17/2025

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 Model Number: C2PIVL4012
• Device Catalogue Number: C2PIVL4012
• Device Lot Number: 01A241111B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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: SNARE - UNKNOWN MANUFACTURER
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female